Chagas Disease
Conditions
Brief summary
Researchers are looking for a better way to treat children who have an infectious disease caused by the parasite Trypanosoma cruzi (Chagas' disease). Chagas'disease is an inflammatory, infectious disease caused by the parasite Trypanosoma cruzi. This parasite is mainly spread by insects called triatomine bug. If Chagas' disease is left untreated, it can later cause serious heart and digestive problems. The study treatment nifurtimox has been used for more than 50 years to treat Chagas' disease. When used early after infection, it kills the parasite. In people who have long-term Chagas' disease, it's no longer possible to kill the parasite. However, nifurtimox may help slow the progression of the disease and its most serious complications. Nifurtimox was developed for use in adults only, but has also been used in children (off-label) for over 40 years. Currently it is available for doctors to give to adults and to children. However, there are not enough data about nifurtimox in children. The main purpose of this study is to learn how well nifurtimox works in children aged 8 months to less than 18 years with Chagas' disease. To answer this, the researchers will compare the amount of antibodies against the parasite Trypanosoma cruzi in the serum (fluid from blood without the clotting factors) between children treated with nifurtimox for 60 days with untreated children from the past (control group): * 12 months and * 4 years after the end of treatment. The data for the control group will come from 2 previous studies conducted in children.
Interventions
For pediatric participants with body weight ≤ 40 kg: dosage 10 to 20 mg/kg/day in three divided doses. For pediatric participants with body weight \> 40 kg: 8 - 10 mg/kg/day in three divided doses. 60 days or 30 days of nifurtimox treatment
DRUGPlacebo
Matching placebo
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
No
Inclusion criteria
Part 1: * Male and female pediatric subjects aged 0 days to younger than 18 years * Chagas' disease diagnosed/ confirmed for a) Subjects \< 8 months of age at randomization must demonstrate direct observation of Trypanosoma cruzi by concentration test; b) Subjects ≥ 8 months to \< 18 years of age at randomization must demonstrate a positive conventional ELISA result for both recombinant ELISA and total purified antigen ELISA Part 2: \- Male and female subjects who were randomized and received at least one dose of their assigned 60- or 30-day regimen of nifurtimox treatment
Exclusion criteria
Part 1: * Subjects aged 0 to 27 days who, at birth, were pre-term, weighed less than 2500 g, or had a maximum Apgar score \< 7 at 5 minutes * Known evidence of Chagas' disease-related cardiomyopathy/ Chagas' heart disease * Known evidence of Chagas' disease-related gastrointestinal dysfunction (e.g. megaoesophagus, megacolon, or both) or Chagas' digestive disease * Serious manifestations of acute Chagas' disease, including myocarditis, meningoencephalitis, or pneumonitis * Known evidence of Chagas' disease-related damage to the peripheral nervous system or peripheral neuropathy * Clinically significant psychiatric disorder (e.g. moderate to severe depression, severe anxiety, or psychosis) or epilepsy * Subjects with contraindications/ warnings to nifurtimox administration, or with conditions that may increase the risk of the undesirable effects of nifurtimox * Subjects who have had previous treatment with trypanocidal agents or an accepted indication for antiparasitic therapy (e.g. reactivation of Chagas' infection due to immunosuppression by several diseases or treatment with steroids) * Subjects living in housing conditions where there is no active or effective vector control to Trypanosoma cruzi reinfection as determined by Ministry of Health guidelines in each country Part 2: * Subjects with acute or chronic health conditions or congenital disorders which, in the opinion of the investigator, would make them unsuitable for participation in the clinical study * Subjects living in housing conditions where there is no active or effective vector-control to Trypanosoma cruzi reinfection as determined by Ministry of Health guideline of the respective country * Subjects with clinical manifestations of Chagas' disease-related gastrointestinal dysfunction or serious manifestations of acute Chagas' disease * Immuno-compromised subjects (e.g. with human immunodeficiency virus or treated with immunosuppressive drugs)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1 - Percentage of Sero-reduction or Sero-conversion (Cured Subjects) | At 12 months post-treatment | Cure is defined as sero-reduction (in subjects ≥8 months to \<18 years of age at randomization) or sero-conversion (in all subjects). Sero-reduction is defined as a ≥20% reduction in optical density \[OD\]) measured by two conventional ELISA serology tests and sero-conversion is defined as negative Immunoglobulin G (IgG) concentration measured by two conventional ELISA serology tests. Subjects who have missing conventional serology results at the 12 month time point were treated as failures (ie, no cure). For the primary objective in the study, superiority over placebo was confirmed if the lower limit of the 95% Confidence Interval (CI) for the nifurtimox (60-day regimen) cure rate is greater than 16%, the larger of the upper limits of the 95% CIs for historical placebo control. |
| Part 2 - Incidence Rate of Seronegative Conversion in Subjects Received at Least One Dose of the 60-day Nifurtimox Treatment Regimen. | Subjects participating in Part 2 were followed up for another 3 years, for a total follow-up period of 4 years after end of nifurtimox treatment in Part 1 | Seronegative conversion measured by two types of assay (recombinant ELISA and indirect hemagglutination assay \[IHA\]) in subjects who were randomized and received at least one dose of the 60-day nifurtimox treatment regimen compared to an external control group of historical placebo patients with Chagas' disease. Incidence rate is the number of new cases of seronegative conversion over the study period (i.e., 4 years after end of nifurtimox treatment) divided by the person-time at risk. It was modelled using a Poisson distribution with a 2-sided 95% exact CI. Number of participants with events were reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part 1 - Mean Changes in Vital Signs (Diastolic Blood Pressure) Between the Treatment Groups From Baseline | Baseline and up to 420 days (Visit 11 post-treatment) | Diastolic Blood Pressure |
| Part 1 - Number of Subjects With Abnormal Urinalysis Findings Considered as Clinically Significant or Reported as Adverse Events (AEs) | Up to 420 days (Visit 11 post-treatment) | Urinalysis was performed and the following parameters evaluated: bilirubin, blood (red blood cells, white blood cells), chorionic gonadotropin β, glucose, ketones, leukocytes, nitrite, pH, protein, specific gravity, and urobilinogen. |
| Part 1 - Number of Subjects With Abnormal ECG Findings Considered as Clinically Significant by Investigators | Up to 420 days (Visit 11 post-treatment) | Clinical significance of abnormal ECG was based on the judgement of the investigator |
| Part 1 - Mean Changes in Vital Signs (Systolic Blood Pressure) Between the Treatment Groups From Baseline | Baseline and up to 420 days (Visit 11 post-treatment) | Systolic Blood Pressure |
| Part 1 - Mean Changes in Vital Signs (Respiratory Rate) Between the Treatment Groups From Baseline | Baseline and up to 420 days (Visit 11 post-treatment) | Respiratory Rate |
| Part 1 - Mean Changes in Vital Signs (Heart Rate) Between the Treatment Groups From Baseline | Baseline and up to 420 days (Visit 11 post-treatment) | Heart Rate |
| Part 1 - Mean Changes in Vital Signs (Body Temperature) Between the Treatment Groups From Baseline | Baseline and up to 420 days (Visit 11 post-treatment) | Temperature |
| Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 2 | At Visit 2 (Day 1): Pre-dose and Post-dose at 5-10 minutes, 10-120 minutes, 2-4 hours, and 4-8 hours | Measured in sub-population. |
| Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 3 | At Visit 3 (Day 7): Pre-dose and Post-dose at 5-10 minutes, 10-120 minutes, 2-4 hours, and 4-8 hours | Measured in sub-population. |
| Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 6 | At Visit 6 (Day 30): Pre-dose and Post-dose at 5-10 minutes, 10-120 minutes, 2-4 hours, and 4-8 hours | The evaluation was based on clinical examinations. Measured in sub-population. |
| Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 8 | At Visit 8 (Day 60): Pre-dose and Post-dose at 5-10 minutes, 10-120 minutes, 2-4 hours, and 4-8 hours | Measured in sub-population. |
| Part 2 - Incidence Rate of Seronegative Conversion in Subjects Who Received at Least One Dose of the 30-day Nifurtimox Treatment Regimen | Subjects participating in Part 2 were followed up for another 3 years, for a total follow-up period of 4 years after end of nifurtimox treatment in Part 1 | Seronegative conversion measured by two types of assay (recombinant ELISA and indirect hemagglutination assay \[IHA\]) in subjects who were randomized and received at least one dose of the 30-day nifurtimox treatment regimen. Incidence rate is the number of new cases of seronegative conversion over the study period (i.e., 4 years after end of nifurtimox treatment) divided by the person-time at risk. It was modelled using a Poisson distribution with a 2-sided 95% exact CI. Number of participants with events were reported. |
| Part 2 - ECG Signs of Established Chagas-related Cardiomyopathy | Subjects participating in Part 2 were followed up for another 3 years, for a total follow-up period of 4 years after end of nifurtimox treatment in Part 1 | Summary of subjects by evidence of established Chagas-related cardiomyopathy as measured by electrocardiogram (ECG). Evidence of established Chagas-related cardiomyopathy: Total |
| Part 2 - Serological Response of Established Chagas-related Cardiomyopathy | Subjects participating in Part 2 were followed up for another 3 years, for a total follow-up period of 4 years after end of nifurtimox treatment in Part 1 | Summary of subjects by evidence of established Chagas-related cardiomyopathy as measured by Serological response. Evidence of established Chagas-related cardiomyopathy: Total |
| Part 1 + Part 2 - Serial Reduction of Optical Density Values Measured by Total Purified Antigen ELISA | Baseline and Subjects participating in Part 2 were followed up for another 3 years, for a total follow-up period of 4 years after end of nifurtimox treatment in Part 1 | Summary and change from baseline of optical density values measured by total purified antigen ELISA. Optical density is the measure of absorbance, and is defined as the ratio of the intensity of light falling upon a material and the intensity transmitted. |
| Part 1 + Part 2 - Serial Reduction of Optical Density Values Measured by Recombinant ELISA | Baseline and Subjects participating in Part 2 were followed up for another 3 years, for a total follow-up period of 4 years after end of nifurtimox treatment in Part 1 | Summary and change from baseline of optical density values measured by recombinant ELISA. Optical density is the measure of absorbance, and is defined as the ratio of the intensity of light falling upon a material and the intensity transmitted. |
| Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 1 | At Visit 1 (before treatment started) | The evaluation was based on clinical examinations. |
| Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 3 | Up to 7 days (Visit 3) | The evaluation was based on clinical examinations. |
| Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 6 | Up to 30 days (Visit 6) | The evaluation was based on clinical examinations. |
| Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 8 | Up to 60 days (Visit 8; end of treatment) | The evaluation was based on clinical examinations. |
| Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 9 | Up to 90 days (Visit 9 post-treatment) | The evaluation was based on clinical examinations. |
| Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 10 | Up to 240 days (Visit 10 post-treatment) | The evaluation was based on clinical examinations. |
| Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 11 | Up to 420 days (Visit 11 post-treatment) | The evaluation was based on clinical examinations. |
| Part 1 - Number of Subjects With Positive Results in Concentration Test for T. Cruzi (for Subjects <8 Months of Age) | Up to 90 days (Visit 9 post-treatment) | — |
| Part 1 - Number of Subjects With a Positive Serological Response Using Non-conventional Enzyme-linked Immunosorbent Assay-F29 (ELISAF29) Test | Up to 420 days (Visit 11 post-treatment) | The non-conventional ELISA-F29 test is considered an early marker of treatment efficacy in chronic Chagas disease. |
| Part 1 - Number of Subjects With Positive Quantitative Polymerase Chain Reaction (qPCR) Results | Up to 420 days (Visit 11 post-treatment) | The qPCR is molecular technique, considered a tool to diagnose acute and congenital Chagas disease, as well as a marker to measure treatment failure when demonstrating positive (detectable) results |
| Part 1 - Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | up to 7 days after last application of study drug | TEAEs comprised events which first occurred or worsened at or after first application of study drug during the course of the study up to and including 7 days after last application of study drug |
| Part 2 - Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Subjects participating in Part 2 were followed up for another 3 years, for a total follow-up period of 4 years after end of nifurtimox treatment in Part 1 | TEAEs comprised events which first occurred or worsened at study start up to end of study in part 2. In Part 2, only AEs considered at least possibly related to nifurtimox (administered in part 1) and those caused by protocol-related procedures were reported. |
| Part 1 - Number of Subjects With Treatment-emergent High Blood Chemistry Abnormalities by Treatment | Up to 420 days (Visit 11 post-treatment) | The Number Analyzed represents the number of subjects at baseline with a normal or lower than normal laboratory assessment who also had at least one valid laboratory value after start of treatment. The number of subjects represents subjects with at least one high laboratory assessment after start of treatment who had a normal or lower than normal laboratory assessment at baseline. |
| Part 1 - Number of Subjects With Treatment-emergent Low Blood Chemistry Abnormalities by Treatment | Up to 420 days (Visit 11 post-treatment) | The number analyzed represents the number of subjects at baseline with a normal or higher than normal laboratory assessment who also had at least one valid laboratory value after start of treatment. The number of subjects represents subjects with at least one low laboratory assessment after start of treatment who had a normal or higher than normal laboratory assessment at baseline. |
| Part 1 - Number of Subjects With Treatment-emergent High Hematology Abnormalities by Treatment | Up to 420 days (Visit 11 post-treatment) | The number analyzed represents the number of subjects at baseline with a normal or lower than normal laboratory assessment who also had at least one valid laboratory value after start of treatment. Subjects with missing or high abnormal values at baseline are not included in the number analyzed. The number of subjects represents subjects with at least one high laboratory assessment after start of treatment who had a normal or lower than normal laboratory assessment at baseline. |
| Part 1 - Number of Subjects With Treatment-emergent Low Hematology Abnormalities by Treatment | Up to 420 days (Visit 11 post-treatment) | The number analyzed represents the number of subjects at baseline with a normal or lower than normal laboratory assessment who also had at least one valid laboratory value after start of treatment. Subjects with missing or low abnormal values at baseline are not included in the number analyzed. The number of subjects represents subjects with at least one low laboratory assessment after start of treatment who had a normal or higher than normal laboratory assessment at baseline. |
| Part 1 - Number of Subjects With Treatment-emergent High Coagulation Abnormalities by Treatment | Up to 420 days (Visit 11 post-treatment) | The Number Analyzed represents the number of subjects at baseline with a normal or lower than normal laboratory assessment who also had at least one valid laboratory value after start of treatment. The number of subjects represents subjects with at least one high laboratory assessment after start of treatment who had a normal or lower than normal laboratory assessment at baseline. |
| Part 1 - Number of Subjects With Treatment-emergent Low Coagulation Abnormalities by Treatment | Up to 420 days (Visit 11 post-treatment) | The number analyzed represents the number of subjects at baseline with a normal or higher than normal laboratory assessment who also had at least one valid laboratory value after start of treatment. The number of subjects represents subjects with at least one low laboratory assessment after start of treatment who had a normal or higher than normal laboratory assessment at baseline. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Part 1 - Relationship of Conventional Serology (Recombinant ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Up to 420 days (Visit 11 post-treatment) | Using frequencies of matches and mismatches to assess agreement Reactive = Reac ELISA Reactive = Reac F29 Non-reactive = Nonreac ELISA Non-reactive= Nonreac F29 |
| Part 1 - Relationship of Conventional Serology (ELISA) to Indirect Hemagglutination Assay (IHA) Results | Up to 420 days (Visit 11 post-treatment) | Sero-reduction is defined as a =\> 20% reduction in optical density \[OD\]) using two conventional ELISA serology tests in subjects =\> 8 months to \< 18 years of age at randomization; Others: reactive results that are not sero-reduction in subjects =\> 8 months to \< 18 years of age at randomization; or reactive results in subjects \< 8 months of age at randomization. Non-reactive ELISA = Nonreac ELISA Non-reactive IHA = Nonreac IHA Reactive IHA decrease = Reac IHA dec React IHA nochange = Reac IHA nochange Reactive ELISA: seroreduction = Reac ELISA reduc Reactive ELISA: others = Reac ELISA other |
| Part 1 - Relationship Between Conventional ELISA Results in Terms of Cure or No Cure and IHA Results in All Patients | Up to 420 days (Visit 11 post-treatment) | Cure is defined as sero-reduction (in subjects =\> 8 months to \< 18 years of age at randomization) or sero-conversion (in all subjects). Sero-reduction is defined as a =\> 20% reduction in optical density \[OD\]) measured by two conventional ELISA serology tests and sero-conversion is defined as negative Immunoglobulin G \[IgG\] concentration measured by two conventional ELISA serology tests. Cure = Cure Non reactive/reactive decreasing = Nonreac/reac dec Reactive non-decreasing = Reac nondec No cure = No Cure Missing IHA testing = IHA missing |
| Part 1: Number of Participants Cured With 60-day Regimen Compared With Historical Active Control (Benznidazole) | Up to 420 days (Visit 11 post-treatment) | This exploratory efficacy analysis evaluated the cure rate assessed as seroconversion of nifurtimox after 1-year post-treatment follow-up with that of published data for benznidazole (Sosa Estani et al. 1998 and de Andrade et al. 1996) at 4- and 3-year post-treatment follow-up, respectively, used as historical control. |
| Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and qPCR Testing by Visit | Up to 420 days (Visit 11 post-treatment) | Using frequencies of matches and mismatches to assess agreement Reactive = Reac ELISA Detectable = Detec qPCR Non-reactive = Nonreac ELISA Non-detectable = Nondetec qPCR Non evaluable = Noneval qPCR qPCR Missing = Miss qPCR Missing conventional testing = Miss ELISA |
| Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Up to 420 days (Visit 11 post-treatment) | Using frequencies of matches and mismatches to assess agreement Reactive = Reac ELISA Reactive = Reac F29 Non-reactive = Nonreac ELISA Non-reactive = Nonreac F29 |
Countries
Argentina, Bolivia, Colombia
Participant flow
Recruitment details
Part 1 of the study was conducted from 27 JAN 2016 (First subject first visit) to 25 JUL 2018 (Last subject last visit) in Argentina, Bolivia and Colombia. Part 2 of the study was conducted from 26 SEP 2018 (First subject first visit) to 10 AUG 2021 (Last subject last visit) in Argentina, Bolivia and Colombia.
Pre-assignment details
Part 1: 330 subjects who were eligible to participate in the study were randomized in a 2:1 ratio to either a 60-Day or 30-Day regimen with nifurtimox tablets. 308 subjects completed treatment in Part 1, and 318 subjects completed Part 1. Part 2: Of the 318 subjects completed Part 1, 295 subjects were included in Part 2.
Participants by arm
| Arm | Count |
|---|---|
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 Nifurtimox tablets administered three times daily for 30 days, followed by placebo administered three times daily for 30 days (Days 1 - 30, active nifurtimox treatment; Days 31 - 60, placebo) | 111 |
| Nifurtimox 60 Days / Arm 1 Nifurtimox tablets administered three times daily for 60 days (Days 1 - 60, active nifurtimox treatment) | 219 |
| Total | 330 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Part 1 | Lost to Follow-up | 9 | 3 |
| Part 2 | Lost to Follow-up | 4 | 6 |
| Part 2 | Other, including due to the COVID-19 Pandemic | 2 | 1 |
Baseline characteristics
| Characteristic | Total | Nifurtimox 60 Days / Arm 1 | Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 |
|---|---|---|---|
| Age, Customized 0 to 27 days | 7 Participants | 4 Participants | 3 Participants |
| Age, Customized 28 days to younger than 8 months | 12 Participants | 8 Participants | 4 Participants |
| Age, Customized 2 years to younger than 18 years | 286 Participants | 190 Participants | 96 Participants |
| Age, Customized 8 months to younger than 2 years | 25 Participants | 17 Participants | 8 Participants |
| Concentration test for T. cruzi Missing | 311 Participants | 207 Participants | 104 Participants |
| Concentration test for T. cruzi Negative | 0 Participants | 0 Participants | 0 Participants |
| Concentration test for T. cruzi Positive | 19 Participants | 12 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 325 Participants | 217 Participants | 108 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 2 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Non conventional ELISA-F29 test results Non Reactive | 116 Participants | 77 Participants | 39 Participants |
| Non conventional ELISA-F29 test results Reactive | 214 Participants | 142 Participants | 72 Participants |
| Race/Ethnicity, Customized American Indian or Alaska native | 94 Participants | 64 Participants | 30 Participants |
| Race/Ethnicity, Customized White | 236 Participants | 155 Participants | 81 Participants |
| Recombinant ELISA OD values | 2.745 No dimension STANDARD_DEVIATION 0.628 | 2.735 No dimension STANDARD_DEVIATION 0.64 | 2.765 No dimension STANDARD_DEVIATION 0.605 |
| Recombinant ELISA test results Non Reactive | 1 Participants | 0 Participants | 1 Participants |
| Recombinant ELISA test results Reactive | 329 Participants | 219 Participants | 110 Participants |
| Sex: Female, Male Female | 178 Participants | 119 Participants | 59 Participants |
| Sex: Female, Male Male | 152 Participants | 100 Participants | 52 Participants |
| Total Purified Antigen ELISA optical density (OD) values | 1.494 No dimension STANDARD_DEVIATION 0.546 | 1.474 No dimension STANDARD_DEVIATION 0.553 | 1.532 No dimension STANDARD_DEVIATION 0.533 |
| Total Purified Antigen enzyme-linked immunosorbent assay (ELISA) test results Non Reactive | 1 Participants | 0 Participants | 1 Participants |
| Total Purified Antigen enzyme-linked immunosorbent assay (ELISA) test results Reactive | 329 Participants | 219 Participants | 110 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 219 | 0 / 111 |
| other Total, other adverse events | 128 / 219 | 51 / 111 |
| serious Total, serious adverse events | 6 / 219 | 3 / 111 |
Outcome results
Primary
Part 1 - Percentage of Sero-reduction or Sero-conversion (Cured Subjects)
Cure is defined as sero-reduction (in subjects ≥8 months to \<18 years of age at randomization) or sero-conversion (in all subjects). Sero-reduction is defined as a ≥20% reduction in optical density \[OD\]) measured by two conventional ELISA serology tests and sero-conversion is defined as negative Immunoglobulin G (IgG) concentration measured by two conventional ELISA serology tests. Subjects who have missing conventional serology results at the 12 month time point were treated as failures (ie, no cure). For the primary objective in the study, superiority over placebo was confirmed if the lower limit of the 95% Confidence Interval (CI) for the nifurtimox (60-day regimen) cure rate is greater than 16%, the larger of the upper limits of the 95% CIs for historical placebo control.
Time frame: At 12 months post-treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nifurtimox 60 Days / Arm 1 | Part 1 - Percentage of Sero-reduction or Sero-conversion (Cured Subjects) | 32.9 Percentage of subjects |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Percentage of Sero-reduction or Sero-conversion (Cured Subjects) | 18.9 Percentage of subjects |
95% CI: [3.7, 24.2]
Primary
Part 2 - Incidence Rate of Seronegative Conversion in Subjects Received at Least One Dose of the 60-day Nifurtimox Treatment Regimen.
Seronegative conversion measured by two types of assay (recombinant ELISA and indirect hemagglutination assay \[IHA\]) in subjects who were randomized and received at least one dose of the 60-day nifurtimox treatment regimen compared to an external control group of historical placebo patients with Chagas' disease. Incidence rate is the number of new cases of seronegative conversion over the study period (i.e., 4 years after end of nifurtimox treatment) divided by the person-time at risk. It was modelled using a Poisson distribution with a 2-sided 95% exact CI. Number of participants with events were reported.
Time frame: Subjects participating in Part 2 were followed up for another 3 years, for a total follow-up period of 4 years after end of nifurtimox treatment in Part 1
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nifurtimox 60 Days / Arm 1 | Part 2 - Incidence Rate of Seronegative Conversion in Subjects Received at Least One Dose of the 60-day Nifurtimox Treatment Regimen. | 16 Participants |
95% CI: [1.21, 3.45]
Secondary
Part 1 - Mean Changes in Vital Signs (Body Temperature) Between the Treatment Groups From Baseline
Temperature
Time frame: Baseline and up to 420 days (Visit 11 post-treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nifurtimox 60 Days / Arm 1 | Part 1 - Mean Changes in Vital Signs (Body Temperature) Between the Treatment Groups From Baseline | VISIT 8 | -0.06 °C | Standard Deviation 0.45 |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Mean Changes in Vital Signs (Body Temperature) Between the Treatment Groups From Baseline | VISIT 3 | -0.10 °C | Standard Deviation 0.36 |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Mean Changes in Vital Signs (Body Temperature) Between the Treatment Groups From Baseline | VISIT 9 | -0.03 °C | Standard Deviation 0.44 |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Mean Changes in Vital Signs (Body Temperature) Between the Treatment Groups From Baseline | VISIT 2 | -0.35 °C | Standard Deviation 0.45 |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Mean Changes in Vital Signs (Body Temperature) Between the Treatment Groups From Baseline | VISIT 10 | -0.07 °C | Standard Deviation 0.49 |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Mean Changes in Vital Signs (Body Temperature) Between the Treatment Groups From Baseline | VISIT 6 | -0.06 °C | Standard Deviation 0.44 |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Mean Changes in Vital Signs (Body Temperature) Between the Treatment Groups From Baseline | VISIT 11 | -0.14 °C | Standard Deviation 0.51 |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Mean Changes in Vital Signs (Body Temperature) Between the Treatment Groups From Baseline | VISIT 1 | 0.01 °C | Standard Deviation 0.39 |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Mean Changes in Vital Signs (Body Temperature) Between the Treatment Groups From Baseline | VISIT 11 | -0.10 °C | Standard Deviation 0.5 |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Mean Changes in Vital Signs (Body Temperature) Between the Treatment Groups From Baseline | VISIT 2 | -0.03 °C | Standard Deviation 0.39 |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Mean Changes in Vital Signs (Body Temperature) Between the Treatment Groups From Baseline | VISIT 3 | 0.04 °C | Standard Deviation 0.43 |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Mean Changes in Vital Signs (Body Temperature) Between the Treatment Groups From Baseline | VISIT 6 | 0 °C | Standard Deviation 0.44 |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Mean Changes in Vital Signs (Body Temperature) Between the Treatment Groups From Baseline | VISIT 8 | 0.05 °C | Standard Deviation 0.42 |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Mean Changes in Vital Signs (Body Temperature) Between the Treatment Groups From Baseline | VISIT 9 | 0.02 °C | Standard Deviation 0.47 |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Mean Changes in Vital Signs (Body Temperature) Between the Treatment Groups From Baseline | VISIT 10 | -0.01 °C | Standard Deviation 0.52 |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Mean Changes in Vital Signs (Body Temperature) Between the Treatment Groups From Baseline | VISIT 1 | 0.04 °C | Standard Deviation 0.36 |
Secondary
Part 1 - Mean Changes in Vital Signs (Diastolic Blood Pressure) Between the Treatment Groups From Baseline
Diastolic Blood Pressure
Time frame: Baseline and up to 420 days (Visit 11 post-treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nifurtimox 60 Days / Arm 1 | Part 1 - Mean Changes in Vital Signs (Diastolic Blood Pressure) Between the Treatment Groups From Baseline | VISIT 1 | 1.00 mmHg | Standard Deviation 7.72 |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Mean Changes in Vital Signs (Diastolic Blood Pressure) Between the Treatment Groups From Baseline | VISIT 2 | -1.25 mmHg | Standard Deviation 2.5 |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Mean Changes in Vital Signs (Diastolic Blood Pressure) Between the Treatment Groups From Baseline | VISIT 3 | 0.76 mmHg | Standard Deviation 8.36 |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Mean Changes in Vital Signs (Diastolic Blood Pressure) Between the Treatment Groups From Baseline | VISIT 6 | 0.26 mmHg | Standard Deviation 10.87 |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Mean Changes in Vital Signs (Diastolic Blood Pressure) Between the Treatment Groups From Baseline | VISIT 8 | 0.08 mmHg | Standard Deviation 9.91 |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Mean Changes in Vital Signs (Diastolic Blood Pressure) Between the Treatment Groups From Baseline | VISIT 9 | -0.68 mmHg | Standard Deviation 8.81 |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Mean Changes in Vital Signs (Diastolic Blood Pressure) Between the Treatment Groups From Baseline | VISIT 10 | 0.99 mmHg | Standard Deviation 9.9 |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Mean Changes in Vital Signs (Diastolic Blood Pressure) Between the Treatment Groups From Baseline | VISIT 11 | 2.30 mmHg | Standard Deviation 11.06 |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Mean Changes in Vital Signs (Diastolic Blood Pressure) Between the Treatment Groups From Baseline | VISIT 11 | 3.25 mmHg | Standard Deviation 10.95 |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Mean Changes in Vital Signs (Diastolic Blood Pressure) Between the Treatment Groups From Baseline | VISIT 1 | 0.90 mmHg | Standard Deviation 7.9 |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Mean Changes in Vital Signs (Diastolic Blood Pressure) Between the Treatment Groups From Baseline | VISIT 8 | 0.93 mmHg | Standard Deviation 10.17 |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Mean Changes in Vital Signs (Diastolic Blood Pressure) Between the Treatment Groups From Baseline | VISIT 2 | -1.00 mmHg | Standard Deviation 2 |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Mean Changes in Vital Signs (Diastolic Blood Pressure) Between the Treatment Groups From Baseline | VISIT 10 | 0.85 mmHg | Standard Deviation 9.53 |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Mean Changes in Vital Signs (Diastolic Blood Pressure) Between the Treatment Groups From Baseline | VISIT 3 | 0.26 mmHg | Standard Deviation 8.05 |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Mean Changes in Vital Signs (Diastolic Blood Pressure) Between the Treatment Groups From Baseline | VISIT 9 | -0.21 mmHg | Standard Deviation 10.03 |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Mean Changes in Vital Signs (Diastolic Blood Pressure) Between the Treatment Groups From Baseline | VISIT 6 | -0.14 mmHg | Standard Deviation 10.21 |
Secondary
Part 1 - Mean Changes in Vital Signs (Heart Rate) Between the Treatment Groups From Baseline
Heart Rate
Time frame: Baseline and up to 420 days (Visit 11 post-treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nifurtimox 60 Days / Arm 1 | Part 1 - Mean Changes in Vital Signs (Heart Rate) Between the Treatment Groups From Baseline | VISIT 1 | -1.08 BEATS/MIN | Standard Deviation 10.19 |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Mean Changes in Vital Signs (Heart Rate) Between the Treatment Groups From Baseline | VISIT 2 | -6.75 BEATS/MIN | Standard Deviation 2.22 |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Mean Changes in Vital Signs (Heart Rate) Between the Treatment Groups From Baseline | VISIT 3 | 0.04 BEATS/MIN | Standard Deviation 10.11 |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Mean Changes in Vital Signs (Heart Rate) Between the Treatment Groups From Baseline | VISIT 6 | -0.78 BEATS/MIN | Standard Deviation 11.49 |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Mean Changes in Vital Signs (Heart Rate) Between the Treatment Groups From Baseline | VISIT 8 | -1.27 BEATS/MIN | Standard Deviation 11.65 |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Mean Changes in Vital Signs (Heart Rate) Between the Treatment Groups From Baseline | VISIT 9 | -1.26 BEATS/MIN | Standard Deviation 11.97 |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Mean Changes in Vital Signs (Heart Rate) Between the Treatment Groups From Baseline | VISIT 10 | -3.28 BEATS/MIN | Standard Deviation 11.87 |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Mean Changes in Vital Signs (Heart Rate) Between the Treatment Groups From Baseline | VISIT 11 | -3.57 BEATS/MIN | Standard Deviation 12.57 |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Mean Changes in Vital Signs (Heart Rate) Between the Treatment Groups From Baseline | VISIT 11 | -4.66 BEATS/MIN | Standard Deviation 14.73 |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Mean Changes in Vital Signs (Heart Rate) Between the Treatment Groups From Baseline | VISIT 1 | 0.26 BEATS/MIN | Standard Deviation 11.37 |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Mean Changes in Vital Signs (Heart Rate) Between the Treatment Groups From Baseline | VISIT 8 | -1.34 BEATS/MIN | Standard Deviation 11.03 |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Mean Changes in Vital Signs (Heart Rate) Between the Treatment Groups From Baseline | VISIT 2 | -0.75 BEATS/MIN | Standard Deviation 2.99 |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Mean Changes in Vital Signs (Heart Rate) Between the Treatment Groups From Baseline | VISIT 10 | -3.28 BEATS/MIN | Standard Deviation 11.61 |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Mean Changes in Vital Signs (Heart Rate) Between the Treatment Groups From Baseline | VISIT 3 | -0.51 BEATS/MIN | Standard Deviation 11.46 |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Mean Changes in Vital Signs (Heart Rate) Between the Treatment Groups From Baseline | VISIT 9 | -1.63 BEATS/MIN | Standard Deviation 10.56 |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Mean Changes in Vital Signs (Heart Rate) Between the Treatment Groups From Baseline | VISIT 6 | -0.75 BEATS/MIN | Standard Deviation 11.92 |
Secondary
Part 1 - Mean Changes in Vital Signs (Respiratory Rate) Between the Treatment Groups From Baseline
Respiratory Rate
Time frame: Baseline and up to 420 days (Visit 11 post-treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nifurtimox 60 Days / Arm 1 | Part 1 - Mean Changes in Vital Signs (Respiratory Rate) Between the Treatment Groups From Baseline | VISIT 1 | 0.12 BREATHS/MIN | Standard Deviation 4.1 |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Mean Changes in Vital Signs (Respiratory Rate) Between the Treatment Groups From Baseline | VISIT 2 | -1.50 BREATHS/MIN | Standard Deviation 3.42 |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Mean Changes in Vital Signs (Respiratory Rate) Between the Treatment Groups From Baseline | VISIT 3 | -0.05 BREATHS/MIN | Standard Deviation 3.15 |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Mean Changes in Vital Signs (Respiratory Rate) Between the Treatment Groups From Baseline | VISIT 6 | -0.57 BREATHS/MIN | Standard Deviation 4.16 |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Mean Changes in Vital Signs (Respiratory Rate) Between the Treatment Groups From Baseline | VISIT 8 | -0.77 BREATHS/MIN | Standard Deviation 4.04 |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Mean Changes in Vital Signs (Respiratory Rate) Between the Treatment Groups From Baseline | VISIT 9 | -1.01 BREATHS/MIN | Standard Deviation 4.06 |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Mean Changes in Vital Signs (Respiratory Rate) Between the Treatment Groups From Baseline | VISIT 10 | -1.36 BREATHS/MIN | Standard Deviation 4.5 |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Mean Changes in Vital Signs (Respiratory Rate) Between the Treatment Groups From Baseline | VISIT 11 | -1.93 BREATHS/MIN | Standard Deviation 5.1 |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Mean Changes in Vital Signs (Respiratory Rate) Between the Treatment Groups From Baseline | VISIT 11 | -0.74 BREATHS/MIN | Standard Deviation 4.61 |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Mean Changes in Vital Signs (Respiratory Rate) Between the Treatment Groups From Baseline | VISIT 1 | 0.47 BREATHS/MIN | Standard Deviation 2.91 |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Mean Changes in Vital Signs (Respiratory Rate) Between the Treatment Groups From Baseline | VISIT 8 | 0.04 BREATHS/MIN | Standard Deviation 4.58 |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Mean Changes in Vital Signs (Respiratory Rate) Between the Treatment Groups From Baseline | VISIT 2 | -1.00 BREATHS/MIN | Standard Deviation 1.15 |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Mean Changes in Vital Signs (Respiratory Rate) Between the Treatment Groups From Baseline | VISIT 10 | -0.24 BREATHS/MIN | Standard Deviation 3.6 |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Mean Changes in Vital Signs (Respiratory Rate) Between the Treatment Groups From Baseline | VISIT 3 | -0.14 BREATHS/MIN | Standard Deviation 3.91 |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Mean Changes in Vital Signs (Respiratory Rate) Between the Treatment Groups From Baseline | VISIT 9 | -0.50 BREATHS/MIN | Standard Deviation 3.76 |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Mean Changes in Vital Signs (Respiratory Rate) Between the Treatment Groups From Baseline | VISIT 6 | -0.06 BREATHS/MIN | Standard Deviation 3.87 |
Secondary
Part 1 - Mean Changes in Vital Signs (Systolic Blood Pressure) Between the Treatment Groups From Baseline
Systolic Blood Pressure
Time frame: Baseline and up to 420 days (Visit 11 post-treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nifurtimox 60 Days / Arm 1 | Part 1 - Mean Changes in Vital Signs (Systolic Blood Pressure) Between the Treatment Groups From Baseline | VISIT 1 | 1.09 mmHg | Standard Deviation 7.79 |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Mean Changes in Vital Signs (Systolic Blood Pressure) Between the Treatment Groups From Baseline | VISIT 2 | -3.75 mmHg | Standard Deviation 7.5 |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Mean Changes in Vital Signs (Systolic Blood Pressure) Between the Treatment Groups From Baseline | VISIT 3 | 1.08 mmHg | Standard Deviation 9.98 |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Mean Changes in Vital Signs (Systolic Blood Pressure) Between the Treatment Groups From Baseline | VISIT 6 | -0.74 mmHg | Standard Deviation 10.7 |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Mean Changes in Vital Signs (Systolic Blood Pressure) Between the Treatment Groups From Baseline | VISIT 8 | -0.41 mmHg | Standard Deviation 11.01 |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Mean Changes in Vital Signs (Systolic Blood Pressure) Between the Treatment Groups From Baseline | VISIT 9 | -0.13 mmHg | Standard Deviation 11.11 |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Mean Changes in Vital Signs (Systolic Blood Pressure) Between the Treatment Groups From Baseline | VISIT 10 | -0.02 mmHg | Standard Deviation 10.46 |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Mean Changes in Vital Signs (Systolic Blood Pressure) Between the Treatment Groups From Baseline | VISIT 11 | 1.20 mmHg | Standard Deviation 11.52 |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Mean Changes in Vital Signs (Systolic Blood Pressure) Between the Treatment Groups From Baseline | VISIT 11 | 1.57 mmHg | Standard Deviation 10.7 |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Mean Changes in Vital Signs (Systolic Blood Pressure) Between the Treatment Groups From Baseline | VISIT 1 | 0.69 mmHg | Standard Deviation 7.85 |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Mean Changes in Vital Signs (Systolic Blood Pressure) Between the Treatment Groups From Baseline | VISIT 8 | 0.48 mmHg | Standard Deviation 11.24 |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Mean Changes in Vital Signs (Systolic Blood Pressure) Between the Treatment Groups From Baseline | VISIT 2 | -5.00 mmHg | Standard Deviation 7.07 |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Mean Changes in Vital Signs (Systolic Blood Pressure) Between the Treatment Groups From Baseline | VISIT 10 | -1.48 mmHg | Standard Deviation 10.95 |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Mean Changes in Vital Signs (Systolic Blood Pressure) Between the Treatment Groups From Baseline | VISIT 3 | -0.50 mmHg | Standard Deviation 8.45 |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Mean Changes in Vital Signs (Systolic Blood Pressure) Between the Treatment Groups From Baseline | VISIT 9 | -0.45 mmHg | Standard Deviation 10.49 |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Mean Changes in Vital Signs (Systolic Blood Pressure) Between the Treatment Groups From Baseline | VISIT 6 | -1.12 mmHg | Standard Deviation 9.89 |
Secondary
Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 2
Measured in sub-population.
Time frame: At Visit 2 (Day 1): Pre-dose and Post-dose at 5-10 minutes, 10-120 minutes, 2-4 hours, and 4-8 hours
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Nifurtimox 60 Days / Arm 1 | Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 2 | 5 - 10 MIN POST | NA ug/L |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 2 | 2 - 4 HOURS POST | 215.4 ug/L |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 2 | 10 - 120 MIN POST | 78.2 ug/L |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 2 | 4 - 8 HOURS POST | 267.6 ug/L |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 2 | Predose | NA ug/L |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 2 | 4 - 8 HOURS POST | 289.6 ug/L |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 2 | Predose | NA ug/L |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 2 | 5 - 10 MIN POST | 21.1 ug/L |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 2 | 10 - 120 MIN POST | 49.0 ug/L |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 2 | 2 - 4 HOURS POST | 300.7 ug/L |
Secondary
Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 3
Measured in sub-population.
Time frame: At Visit 3 (Day 7): Pre-dose and Post-dose at 5-10 minutes, 10-120 minutes, 2-4 hours, and 4-8 hours
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Nifurtimox 60 Days / Arm 1 | Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 3 | 5 - 10 MIN POST | 82.6 ug/L |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 3 | 2 - 4 HOURS POST | 497.2 ug/L |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 3 | 10 - 120 MIN POST | 250.6 ug/L |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 3 | 4 - 8 HOURS POST | 427.5 ug/L |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 3 | Predose | 47.7 ug/L |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 3 | 4 - 8 HOURS POST | 267.0 ug/L |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 3 | Predose | 38.3 ug/L |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 3 | 5 - 10 MIN POST | 56.0 ug/L |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 3 | 10 - 120 MIN POST | 232.3 ug/L |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 3 | 2 - 4 HOURS POST | 257.7 ug/L |
Secondary
Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 6
The evaluation was based on clinical examinations. Measured in sub-population.
Time frame: At Visit 6 (Day 30): Pre-dose and Post-dose at 5-10 minutes, 10-120 minutes, 2-4 hours, and 4-8 hours
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Nifurtimox 60 Days / Arm 1 | Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 6 | 5 - 10 MIN POST | 71.7 ug/L |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 6 | 2 - 4 HOURS POST | 369.5 ug/L |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 6 | 10 - 120 MIN POST | 135.0 ug/L |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 6 | 4 - 8 HOURS POST | 249.7 ug/L |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 6 | Predose | 23.8 ug/L |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 6 | 4 - 8 HOURS POST | 165.2 ug/L |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 6 | Predose | 40.8 ug/L |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 6 | 5 - 10 MIN POST | 73.7 ug/L |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 6 | 10 - 120 MIN POST | 172.7 ug/L |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 6 | 2 - 4 HOURS POST | 103.8 ug/L |
Secondary
Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 8
Measured in sub-population.
Time frame: At Visit 8 (Day 60): Pre-dose and Post-dose at 5-10 minutes, 10-120 minutes, 2-4 hours, and 4-8 hours
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Nifurtimox 60 Days / Arm 1 | Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 8 | 5 - 10 MIN POST | 92.4 ug/L |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 8 | 2 - 4 HOURS POST | 395.6 ug/L |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 8 | 10 - 120 MIN POST | 139.1 ug/L |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 8 | 4 - 8 HOURS POST | 300.6 ug/L |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 8 | Predose | NA ug/L |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 8 | 4 - 8 HOURS POST | NA ug/L |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 8 | Predose | NA ug/L |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 8 | 5 - 10 MIN POST | NA ug/L |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 8 | 10 - 120 MIN POST | NA ug/L |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 8 | 2 - 4 HOURS POST | NA ug/L |
Secondary
Part 1 - Number of Subjects With Abnormal ECG Findings Considered as Clinically Significant by Investigators
Clinical significance of abnormal ECG was based on the judgement of the investigator
Time frame: Up to 420 days (Visit 11 post-treatment)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Abnormal ECG Findings Considered as Clinically Significant by Investigators | 0 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Abnormal ECG Findings Considered as Clinically Significant by Investigators | 0 Participants |
Secondary
Part 1 - Number of Subjects With Abnormal Urinalysis Findings Considered as Clinically Significant or Reported as Adverse Events (AEs)
Urinalysis was performed and the following parameters evaluated: bilirubin, blood (red blood cells, white blood cells), chorionic gonadotropin β, glucose, ketones, leukocytes, nitrite, pH, protein, specific gravity, and urobilinogen.
Time frame: Up to 420 days (Visit 11 post-treatment)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Abnormal Urinalysis Findings Considered as Clinically Significant or Reported as Adverse Events (AEs) | 0 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Abnormal Urinalysis Findings Considered as Clinically Significant or Reported as Adverse Events (AEs) | 0 Participants |
Secondary
Part 1 - Number of Subjects With a Positive Serological Response Using Non-conventional Enzyme-linked Immunosorbent Assay-F29 (ELISAF29) Test
The non-conventional ELISA-F29 test is considered an early marker of treatment efficacy in chronic Chagas disease.
Time frame: Up to 420 days (Visit 11 post-treatment)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With a Positive Serological Response Using Non-conventional Enzyme-linked Immunosorbent Assay-F29 (ELISAF29) Test | Reactive | 96 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With a Positive Serological Response Using Non-conventional Enzyme-linked Immunosorbent Assay-F29 (ELISAF29) Test | Non-reactive | 114 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With a Positive Serological Response Using Non-conventional Enzyme-linked Immunosorbent Assay-F29 (ELISAF29) Test | Missing | 9 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With a Positive Serological Response Using Non-conventional Enzyme-linked Immunosorbent Assay-F29 (ELISAF29) Test | Reactive | 54 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With a Positive Serological Response Using Non-conventional Enzyme-linked Immunosorbent Assay-F29 (ELISAF29) Test | Non-reactive | 54 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With a Positive Serological Response Using Non-conventional Enzyme-linked Immunosorbent Assay-F29 (ELISAF29) Test | Missing | 3 Participants |
Secondary
Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 1
The evaluation was based on clinical examinations.
Time frame: At Visit 1 (before treatment started)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 1 | 2 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 1 | 0 Participants |
Secondary
Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 10
The evaluation was based on clinical examinations.
Time frame: Up to 240 days (Visit 10 post-treatment)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 10 | 1 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 10 | 0 Participants |
Secondary
Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 11
The evaluation was based on clinical examinations.
Time frame: Up to 420 days (Visit 11 post-treatment)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 11 | 3 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 11 | 3 Participants |
Secondary
Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 3
The evaluation was based on clinical examinations.
Time frame: Up to 7 days (Visit 3)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 3 | Anemia | 1 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 3 | Chagas disease | 2 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 3 | Hepatomegaly | 1 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 3 | Known ECG abnormality | 4 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 3 | Known ECG abnormality | 0 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 3 | Anemia | 0 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 3 | Hepatomegaly | 0 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 3 | Chagas disease | 0 Participants |
Secondary
Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 6
The evaluation was based on clinical examinations.
Time frame: Up to 30 days (Visit 6)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 6 | Known ECG abnormality | 1 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 6 | Romana sign | 0 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 6 | Known ECG abnormality | 0 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 6 | Romana sign | 1 Participants |
Secondary
Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 8
The evaluation was based on clinical examinations.
Time frame: Up to 60 days (Visit 8; end of treatment)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 8 | Anemia | 1 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 8 | Chagas disease | 1 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 8 | Known ECG abnormality | 1 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 8 | Lymphadenopathy | 1 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 8 | Lymphadenopathy | 0 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 8 | Anemia | 0 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 8 | Known ECG abnormality | 0 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 8 | Chagas disease | 0 Participants |
Secondary
Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 9
The evaluation was based on clinical examinations.
Time frame: Up to 90 days (Visit 9 post-treatment)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 9 | 1 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 9 | 0 Participants |
Secondary
Part 1 - Number of Subjects With Positive Quantitative Polymerase Chain Reaction (qPCR) Results
The qPCR is molecular technique, considered a tool to diagnose acute and congenital Chagas disease, as well as a marker to measure treatment failure when demonstrating positive (detectable) results
Time frame: Up to 420 days (Visit 11 post-treatment)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Positive Quantitative Polymerase Chain Reaction (qPCR) Results | Visit 3 - Non-evaluable | 0 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Positive Quantitative Polymerase Chain Reaction (qPCR) Results | Visit 1 - Detectable | 117 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Positive Quantitative Polymerase Chain Reaction (qPCR) Results | Visit 1 - Non-evaluable | 1 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Positive Quantitative Polymerase Chain Reaction (qPCR) Results | Visit 1 - Missing | 2 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Positive Quantitative Polymerase Chain Reaction (qPCR) Results | Visit 3 - Non-detectable | 171 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Positive Quantitative Polymerase Chain Reaction (qPCR) Results | Visit 3 - Detectable | 46 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Positive Quantitative Polymerase Chain Reaction (qPCR) Results | Visit 1 - Non-detectable | 99 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Positive Quantitative Polymerase Chain Reaction (qPCR) Results | Visit 3 - Missing | 2 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Positive Quantitative Polymerase Chain Reaction (qPCR) Results | Visit 6 - Non-detectable | 207 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Positive Quantitative Polymerase Chain Reaction (qPCR) Results | Visit 6 - Detectable | 4 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Positive Quantitative Polymerase Chain Reaction (qPCR) Results | Visit 6 - Non-evaluable | 3 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Positive Quantitative Polymerase Chain Reaction (qPCR) Results | Visit 6 - Missing | 5 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Positive Quantitative Polymerase Chain Reaction (qPCR) Results | Visit 8 - Non-detectable | 210 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Positive Quantitative Polymerase Chain Reaction (qPCR) Results | Visit 8 - Detectable | 3 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Positive Quantitative Polymerase Chain Reaction (qPCR) Results | Visit 8 - Non-evaluable | 2 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Positive Quantitative Polymerase Chain Reaction (qPCR) Results | Visit 8 - Missing | 4 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Positive Quantitative Polymerase Chain Reaction (qPCR) Results | Visit 10 - Non-detectable | 206 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Positive Quantitative Polymerase Chain Reaction (qPCR) Results | Visit 10 - Detectable | 3 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Positive Quantitative Polymerase Chain Reaction (qPCR) Results | Visit 10 - Non-evaluable | 2 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Positive Quantitative Polymerase Chain Reaction (qPCR) Results | Visit 10 - Missing | 8 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Positive Quantitative Polymerase Chain Reaction (qPCR) Results | Visit 11 - Non-detectable | 205 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Positive Quantitative Polymerase Chain Reaction (qPCR) Results | Visit 11 - Detectable | 3 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Positive Quantitative Polymerase Chain Reaction (qPCR) Results | Visit 11 - Non-evaluable | 1 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Positive Quantitative Polymerase Chain Reaction (qPCR) Results | Visit 11 - Missing | 10 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Positive Quantitative Polymerase Chain Reaction (qPCR) Results | Visit 11 - Non-evaluable | 1 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Positive Quantitative Polymerase Chain Reaction (qPCR) Results | Visit 1 - Non-detectable | 53 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Positive Quantitative Polymerase Chain Reaction (qPCR) Results | Visit 8 - Non-detectable | 105 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Positive Quantitative Polymerase Chain Reaction (qPCR) Results | Visit 1 - Detectable | 57 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Positive Quantitative Polymerase Chain Reaction (qPCR) Results | Visit 10 - Non-evaluable | 2 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Positive Quantitative Polymerase Chain Reaction (qPCR) Results | Visit 1 - Non-evaluable | 1 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Positive Quantitative Polymerase Chain Reaction (qPCR) Results | Visit 8 - Detectable | 1 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Positive Quantitative Polymerase Chain Reaction (qPCR) Results | Visit 1 - Missing | 0 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Positive Quantitative Polymerase Chain Reaction (qPCR) Results | Visit 11 - Detectable | 5 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Positive Quantitative Polymerase Chain Reaction (qPCR) Results | Visit 3 - Non-detectable | 86 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Positive Quantitative Polymerase Chain Reaction (qPCR) Results | Visit 8 - Non-evaluable | 2 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Positive Quantitative Polymerase Chain Reaction (qPCR) Results | Visit 3 - Detectable | 21 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Positive Quantitative Polymerase Chain Reaction (qPCR) Results | Visit 10 - Missing | 2 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Positive Quantitative Polymerase Chain Reaction (qPCR) Results | Visit 3 - Non-evaluable | 1 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Positive Quantitative Polymerase Chain Reaction (qPCR) Results | Visit 8 - Missing | 3 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Positive Quantitative Polymerase Chain Reaction (qPCR) Results | Visit 3 - Missing | 3 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Positive Quantitative Polymerase Chain Reaction (qPCR) Results | Visit 11 - Missing | 3 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Positive Quantitative Polymerase Chain Reaction (qPCR) Results | Visit 6 - Non-detectable | 105 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Positive Quantitative Polymerase Chain Reaction (qPCR) Results | Visit 10 - Non-detectable | 105 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Positive Quantitative Polymerase Chain Reaction (qPCR) Results | Visit 6 - Detectable | 3 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Positive Quantitative Polymerase Chain Reaction (qPCR) Results | Visit 11 - Non-detectable | 102 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Positive Quantitative Polymerase Chain Reaction (qPCR) Results | Visit 6 - Non-evaluable | 2 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Positive Quantitative Polymerase Chain Reaction (qPCR) Results | Visit 10 - Detectable | 2 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Positive Quantitative Polymerase Chain Reaction (qPCR) Results | Visit 6 - Missing | 1 Participants |
Secondary
Part 1 - Number of Subjects With Positive Results in Concentration Test for T. Cruzi (for Subjects <8 Months of Age)
Time frame: Up to 90 days (Visit 9 post-treatment)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Positive Results in Concentration Test for T. Cruzi (for Subjects <8 Months of Age) | Visit 8|Positive | 0 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Positive Results in Concentration Test for T. Cruzi (for Subjects <8 Months of Age) | Visit 8|Negative | 12 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Positive Results in Concentration Test for T. Cruzi (for Subjects <8 Months of Age) | Visit 1|Positive | 12 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Positive Results in Concentration Test for T. Cruzi (for Subjects <8 Months of Age) | Visit 9|Negative | 11 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Positive Results in Concentration Test for T. Cruzi (for Subjects <8 Months of Age) | Visit 9|Positive | 1 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Positive Results in Concentration Test for T. Cruzi (for Subjects <8 Months of Age) | Visit 1|Missing | 0 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Positive Results in Concentration Test for T. Cruzi (for Subjects <8 Months of Age) | Visit 6|Positive | 0 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Positive Results in Concentration Test for T. Cruzi (for Subjects <8 Months of Age) | Visit 3|Missing | 0 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Positive Results in Concentration Test for T. Cruzi (for Subjects <8 Months of Age) | Visit 1|Negative | 0 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Positive Results in Concentration Test for T. Cruzi (for Subjects <8 Months of Age) | Visit 6|Missing | 0 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Positive Results in Concentration Test for T. Cruzi (for Subjects <8 Months of Age) | Visit 3|Positive | 1 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Positive Results in Concentration Test for T. Cruzi (for Subjects <8 Months of Age) | Visit 8|Missing | 0 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Positive Results in Concentration Test for T. Cruzi (for Subjects <8 Months of Age) | Visit 3|Negative | 11 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Positive Results in Concentration Test for T. Cruzi (for Subjects <8 Months of Age) | Visit 9|Missing | 0 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Positive Results in Concentration Test for T. Cruzi (for Subjects <8 Months of Age) | Visit 6|Negative | 12 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Positive Results in Concentration Test for T. Cruzi (for Subjects <8 Months of Age) | Visit 9|Missing | 0 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Positive Results in Concentration Test for T. Cruzi (for Subjects <8 Months of Age) | Visit 1|Positive | 7 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Positive Results in Concentration Test for T. Cruzi (for Subjects <8 Months of Age) | Visit 3|Positive | 1 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Positive Results in Concentration Test for T. Cruzi (for Subjects <8 Months of Age) | Visit 6|Positive | 0 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Positive Results in Concentration Test for T. Cruzi (for Subjects <8 Months of Age) | Visit 8|Positive | 0 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Positive Results in Concentration Test for T. Cruzi (for Subjects <8 Months of Age) | Visit 9|Positive | 0 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Positive Results in Concentration Test for T. Cruzi (for Subjects <8 Months of Age) | Visit 1|Negative | 0 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Positive Results in Concentration Test for T. Cruzi (for Subjects <8 Months of Age) | Visit 6|Negative | 7 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Positive Results in Concentration Test for T. Cruzi (for Subjects <8 Months of Age) | Visit 8|Negative | 7 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Positive Results in Concentration Test for T. Cruzi (for Subjects <8 Months of Age) | Visit 9|Negative | 7 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Positive Results in Concentration Test for T. Cruzi (for Subjects <8 Months of Age) | Visit 1|Missing | 0 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Positive Results in Concentration Test for T. Cruzi (for Subjects <8 Months of Age) | Visit 3|Missing | 1 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Positive Results in Concentration Test for T. Cruzi (for Subjects <8 Months of Age) | Visit 6|Missing | 0 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Positive Results in Concentration Test for T. Cruzi (for Subjects <8 Months of Age) | Visit 8|Missing | 0 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Positive Results in Concentration Test for T. Cruzi (for Subjects <8 Months of Age) | Visit 3|Negative | 5 Participants |
Secondary
Part 1 - Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
TEAEs comprised events which first occurred or worsened at or after first application of study drug during the course of the study up to and including 7 days after last application of study drug
Time frame: up to 7 days after last application of study drug
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Any treatment-emergent adverse event (TEAE) | 147 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Any Serious TEAE | 6 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Any treatment-emergent adverse event (TEAE) | 66 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Any Serious TEAE | 3 Participants |
Secondary
Part 1 - Number of Subjects With Treatment-emergent High Blood Chemistry Abnormalities by Treatment
The Number Analyzed represents the number of subjects at baseline with a normal or lower than normal laboratory assessment who also had at least one valid laboratory value after start of treatment. The number of subjects represents subjects with at least one high laboratory assessment after start of treatment who had a normal or lower than normal laboratory assessment at baseline.
Time frame: Up to 420 days (Visit 11 post-treatment)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent High Blood Chemistry Abnormalities by Treatment | Alanine Aminotransferase (U/L) | 19 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent High Blood Chemistry Abnormalities by Treatment | Direct Bilirubin (mg/dL) | 21 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent High Blood Chemistry Abnormalities by Treatment | Alkaline Phosphatase (U/L) | 11 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent High Blood Chemistry Abnormalities by Treatment | Blood Urea Nitrogen (mg/dL) | 11 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent High Blood Chemistry Abnormalities by Treatment | Aspartate Aminotransferase (U/L) | 27 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent High Blood Chemistry Abnormalities by Treatment | Urate (mg/dL) | 7 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent High Blood Chemistry Abnormalities by Treatment | Albumin (g/dL) | 49 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent High Blood Chemistry Abnormalities by Treatment | Glucose (mg/dL) | 15 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent High Blood Chemistry Abnormalities by Treatment | Bilirubin (mg/dL) | 19 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent High Blood Chemistry Abnormalities by Treatment | Protein (g/dL) | 42 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent High Blood Chemistry Abnormalities by Treatment | Creatinine (mg/dL) | 3 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent High Blood Chemistry Abnormalities by Treatment | Protein (g/dL) | 14 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent High Blood Chemistry Abnormalities by Treatment | Creatinine (mg/dL) | 2 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent High Blood Chemistry Abnormalities by Treatment | Albumin (g/dL) | 21 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent High Blood Chemistry Abnormalities by Treatment | Alkaline Phosphatase (U/L) | 3 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent High Blood Chemistry Abnormalities by Treatment | Alanine Aminotransferase (U/L) | 7 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent High Blood Chemistry Abnormalities by Treatment | Aspartate Aminotransferase (U/L) | 7 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent High Blood Chemistry Abnormalities by Treatment | Bilirubin (mg/dL) | 9 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent High Blood Chemistry Abnormalities by Treatment | Direct Bilirubin (mg/dL) | 9 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent High Blood Chemistry Abnormalities by Treatment | Blood Urea Nitrogen (mg/dL) | 3 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent High Blood Chemistry Abnormalities by Treatment | Urate (mg/dL) | 1 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent High Blood Chemistry Abnormalities by Treatment | Glucose (mg/dL) | 13 Participants |
Secondary
Part 1 - Number of Subjects With Treatment-emergent High Coagulation Abnormalities by Treatment
The Number Analyzed represents the number of subjects at baseline with a normal or lower than normal laboratory assessment who also had at least one valid laboratory value after start of treatment. The number of subjects represents subjects with at least one high laboratory assessment after start of treatment who had a normal or lower than normal laboratory assessment at baseline.
Time frame: Up to 420 days (Visit 11 post-treatment)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent High Coagulation Abnormalities by Treatment | Prothrombin Time (sec) in Plasma | 38 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent High Coagulation Abnormalities by Treatment | Activated Partial Thromboplastin | 9 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent High Coagulation Abnormalities by Treatment | Time in Plasma Prothrombin Intl. Normalized Ratio | 21 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent High Coagulation Abnormalities by Treatment | Prothrombin Time (sec) in Plasma | 23 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent High Coagulation Abnormalities by Treatment | Activated Partial Thromboplastin | 10 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent High Coagulation Abnormalities by Treatment | Time in Plasma Prothrombin Intl. Normalized Ratio | 13 Participants |
Secondary
Part 1 - Number of Subjects With Treatment-emergent High Hematology Abnormalities by Treatment
The number analyzed represents the number of subjects at baseline with a normal or lower than normal laboratory assessment who also had at least one valid laboratory value after start of treatment. Subjects with missing or high abnormal values at baseline are not included in the number analyzed. The number of subjects represents subjects with at least one high laboratory assessment after start of treatment who had a normal or lower than normal laboratory assessment at baseline.
Time frame: Up to 420 days (Visit 11 post-treatment)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent High Hematology Abnormalities by Treatment | Hematocrit (% | 19 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent High Hematology Abnormalities by Treatment | Hemoglobin (g/dL) | 15 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent High Hematology Abnormalities by Treatment | Erythrocytes (T/L) in Blood | 21 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent High Hematology Abnormalities by Treatment | Ery. Mean Corpuscular Volume (fL) in Blood | 20 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent High Hematology Abnormalities by Treatment | Ery. Mean Corpuscular Hemoglobin (pg) in Blood | 14 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent High Hematology Abnormalities by Treatment | Ery. Mean Corpuscular HGB Conc. (g/dL) in Blood | 23 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent High Hematology Abnormalities by Treatment | Leukocytes (GIGA/L) in Blood | 41 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent High Hematology Abnormalities by Treatment | Neutrophils/Leukocytes (%) | 38 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent High Hematology Abnormalities by Treatment | Neutrophils (GIGA/L) | 36 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent High Hematology Abnormalities by Treatment | Lymphocytes/Leukocytes (%) | 35 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent High Hematology Abnormalities by Treatment | Lymphocytes (GIGA/L) | 21 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent High Hematology Abnormalities by Treatment | Monocytes/Leukocytes (%) | 33 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent High Hematology Abnormalities by Treatment | Monocytes (GIGA/L) | 17 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent High Hematology Abnormalities by Treatment | Eosinophils/Leukocytes (%) | 58 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent High Hematology Abnormalities by Treatment | Eosinophils (GIGA/L) | 53 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent High Hematology Abnormalities by Treatment | Basophils/Leukocytes (%) | 20 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent High Hematology Abnormalities by Treatment | Basophils (GIGA/L) | 10 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent High Hematology Abnormalities by Treatment | Platelets (GIGA/L) in Blood | 27 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent High Hematology Abnormalities by Treatment | Eosinophils/Leukocytes (%) | 26 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent High Hematology Abnormalities by Treatment | Hematocrit (% | 8 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent High Hematology Abnormalities by Treatment | Lymphocytes/Leukocytes (%) | 17 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent High Hematology Abnormalities by Treatment | Hemoglobin (g/dL) | 3 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent High Hematology Abnormalities by Treatment | Platelets (GIGA/L) in Blood | 13 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent High Hematology Abnormalities by Treatment | Erythrocytes (T/L) in Blood | 9 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent High Hematology Abnormalities by Treatment | Lymphocytes (GIGA/L) | 7 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent High Hematology Abnormalities by Treatment | Ery. Mean Corpuscular Volume (fL) in Blood | 7 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent High Hematology Abnormalities by Treatment | Eosinophils (GIGA/L) | 22 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent High Hematology Abnormalities by Treatment | Ery. Mean Corpuscular Hemoglobin (pg) in Blood | 5 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent High Hematology Abnormalities by Treatment | Monocytes/Leukocytes (%) | 17 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent High Hematology Abnormalities by Treatment | Ery. Mean Corpuscular HGB Conc. (g/dL) in Blood | 6 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent High Hematology Abnormalities by Treatment | Basophils (GIGA/L) | 2 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent High Hematology Abnormalities by Treatment | Leukocytes (GIGA/L) in Blood | 16 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent High Hematology Abnormalities by Treatment | Monocytes (GIGA/L) | 15 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent High Hematology Abnormalities by Treatment | Neutrophils/Leukocytes (%) | 12 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent High Hematology Abnormalities by Treatment | Basophils/Leukocytes (%) | 7 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent High Hematology Abnormalities by Treatment | Neutrophils (GIGA/L) | 8 Participants |
Secondary
Part 1 - Number of Subjects With Treatment-emergent Low Blood Chemistry Abnormalities by Treatment
The number analyzed represents the number of subjects at baseline with a normal or higher than normal laboratory assessment who also had at least one valid laboratory value after start of treatment. The number of subjects represents subjects with at least one low laboratory assessment after start of treatment who had a normal or higher than normal laboratory assessment at baseline.
Time frame: Up to 420 days (Visit 11 post-treatment)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent Low Blood Chemistry Abnormalities by Treatment | Alanine Aminotransferase (U/L) | 6 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent Low Blood Chemistry Abnormalities by Treatment | Direct Bilirubin (mg/dL) | 0 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent Low Blood Chemistry Abnormalities by Treatment | Alkaline Phosphatase (U/L) | 4 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent Low Blood Chemistry Abnormalities by Treatment | Blood Urea Nitrogen (mg/dL) | 31 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent Low Blood Chemistry Abnormalities by Treatment | Aspartate Aminotransferase (U/L) | 1 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent Low Blood Chemistry Abnormalities by Treatment | Urate (mg/dL) | 32 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent Low Blood Chemistry Abnormalities by Treatment | Albumin (g/dL) | 14 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent Low Blood Chemistry Abnormalities by Treatment | Glucose (mg/dL) | 29 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent Low Blood Chemistry Abnormalities by Treatment | Bilirubin (mg/dL) | 7 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent Low Blood Chemistry Abnormalities by Treatment | Protein (g/dL) | 17 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent Low Blood Chemistry Abnormalities by Treatment | Creatinine (mg/dL) | 22 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent Low Blood Chemistry Abnormalities by Treatment | Protein (g/dL) | 15 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent Low Blood Chemistry Abnormalities by Treatment | Creatinine (mg/dL) | 10 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent Low Blood Chemistry Abnormalities by Treatment | Albumin (g/dL) | 4 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent Low Blood Chemistry Abnormalities by Treatment | Alkaline Phosphatase (U/L) | 4 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent Low Blood Chemistry Abnormalities by Treatment | Alanine Aminotransferase (U/L) | 3 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent Low Blood Chemistry Abnormalities by Treatment | Aspartate Aminotransferase (U/L) | 5 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent Low Blood Chemistry Abnormalities by Treatment | Bilirubin (mg/dL) | 3 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent Low Blood Chemistry Abnormalities by Treatment | Direct Bilirubin (mg/dL) | 0 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent Low Blood Chemistry Abnormalities by Treatment | Blood Urea Nitrogen (mg/dL) | 15 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent Low Blood Chemistry Abnormalities by Treatment | Urate (mg/dL) | 18 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent Low Blood Chemistry Abnormalities by Treatment | Glucose (mg/dL) | 18 Participants |
Secondary
Part 1 - Number of Subjects With Treatment-emergent Low Coagulation Abnormalities by Treatment
The number analyzed represents the number of subjects at baseline with a normal or higher than normal laboratory assessment who also had at least one valid laboratory value after start of treatment. The number of subjects represents subjects with at least one low laboratory assessment after start of treatment who had a normal or higher than normal laboratory assessment at baseline.
Time frame: Up to 420 days (Visit 11 post-treatment)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent Low Coagulation Abnormalities by Treatment | Prothrombin Time (sec) in Plasma | 10 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent Low Coagulation Abnormalities by Treatment | Activated Partial Thromboplastin | 15 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent Low Coagulation Abnormalities by Treatment | Time in Plasma Prothrombin Intl. Normalized Ratio | 14 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent Low Coagulation Abnormalities by Treatment | Prothrombin Time (sec) in Plasma | 5 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent Low Coagulation Abnormalities by Treatment | Activated Partial Thromboplastin | 2 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent Low Coagulation Abnormalities by Treatment | Time in Plasma Prothrombin Intl. Normalized Ratio | 5 Participants |
Secondary
Part 1 - Number of Subjects With Treatment-emergent Low Hematology Abnormalities by Treatment
The number analyzed represents the number of subjects at baseline with a normal or lower than normal laboratory assessment who also had at least one valid laboratory value after start of treatment. Subjects with missing or low abnormal values at baseline are not included in the number analyzed. The number of subjects represents subjects with at least one low laboratory assessment after start of treatment who had a normal or higher than normal laboratory assessment at baseline.
Time frame: Up to 420 days (Visit 11 post-treatment)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent Low Hematology Abnormalities by Treatment | Hematocrit (% | 30 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent Low Hematology Abnormalities by Treatment | Hemoglobin (g/dL) | 23 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent Low Hematology Abnormalities by Treatment | Erythrocytes (T/L) in Blood | 15 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent Low Hematology Abnormalities by Treatment | Ery. Mean Corpuscular Volume (fL) in Blood | 16 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent Low Hematology Abnormalities by Treatment | Ery. Mean Corpuscular Hemoglobin (pg) in Blood | 19 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent Low Hematology Abnormalities by Treatment | Ery. Mean Corpuscular HGB Conc. (g/dL) in Blood | 29 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent Low Hematology Abnormalities by Treatment | Leukocytes (GIGA/L) in Blood | 39 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent Low Hematology Abnormalities by Treatment | Neutrophils/Leukocytes (%) | 53 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent Low Hematology Abnormalities by Treatment | Neutrophils (GIGA/L) | 46 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent Low Hematology Abnormalities by Treatment | Lymphocytes/Leukocytes (%) | 40 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent Low Hematology Abnormalities by Treatment | Lymphocytes (GIGA/L) | 5 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent Low Hematology Abnormalities by Treatment | Monocytes/Leukocytes (%) | 54 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent Low Hematology Abnormalities by Treatment | Monocytes (GIGA/L) | 33 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent Low Hematology Abnormalities by Treatment | Eosinophils/Leukocytes (%) | 13 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent Low Hematology Abnormalities by Treatment | Eosinophils (GIGA/L) | 14 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent Low Hematology Abnormalities by Treatment | Basophils/Leukocytes (%) | 1 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent Low Hematology Abnormalities by Treatment | Basophils (GIGA/L) | 1 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Number of Subjects With Treatment-emergent Low Hematology Abnormalities by Treatment | Platelets (GIGA/L) in Blood | 6 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent Low Hematology Abnormalities by Treatment | Eosinophils/Leukocytes (%) | 5 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent Low Hematology Abnormalities by Treatment | Hematocrit (% | 17 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent Low Hematology Abnormalities by Treatment | Lymphocytes/Leukocytes (%) | 9 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent Low Hematology Abnormalities by Treatment | Hemoglobin (g/dL) | 17 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent Low Hematology Abnormalities by Treatment | Platelets (GIGA/L) in Blood | 3 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent Low Hematology Abnormalities by Treatment | Erythrocytes (T/L) in Blood | 9 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent Low Hematology Abnormalities by Treatment | Lymphocytes (GIGA/L) | 0 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent Low Hematology Abnormalities by Treatment | Ery. Mean Corpuscular Volume (fL) in Blood | 6 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent Low Hematology Abnormalities by Treatment | Eosinophils (GIGA/L) | 5 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent Low Hematology Abnormalities by Treatment | Ery. Mean Corpuscular Hemoglobin (pg) in Blood | 10 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent Low Hematology Abnormalities by Treatment | Monocytes/Leukocytes (%) | 28 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent Low Hematology Abnormalities by Treatment | Ery. Mean Corpuscular HGB Conc. (g/dL) in Blood | 21 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent Low Hematology Abnormalities by Treatment | Basophils (GIGA/L) | 2 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent Low Hematology Abnormalities by Treatment | Leukocytes (GIGA/L) in Blood | 18 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent Low Hematology Abnormalities by Treatment | Monocytes (GIGA/L) | 22 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent Low Hematology Abnormalities by Treatment | Neutrophils/Leukocytes (%) | 27 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent Low Hematology Abnormalities by Treatment | Basophils/Leukocytes (%) | 2 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Number of Subjects With Treatment-emergent Low Hematology Abnormalities by Treatment | Neutrophils (GIGA/L) | 25 Participants |
Secondary
Part 1 + Part 2 - Serial Reduction of Optical Density Values Measured by Recombinant ELISA
Summary and change from baseline of optical density values measured by recombinant ELISA. Optical density is the measure of absorbance, and is defined as the ratio of the intensity of light falling upon a material and the intensity transmitted.
Time frame: Baseline and Subjects participating in Part 2 were followed up for another 3 years, for a total follow-up period of 4 years after end of nifurtimox treatment in Part 1
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nifurtimox 60 Days / Arm 1 | Part 1 + Part 2 - Serial Reduction of Optical Density Values Measured by Recombinant ELISA | Part 1 - Up to 420 days post-treatment (Visit 11) | 2.27 Optical density | Standard Deviation 0.98 |
| Nifurtimox 60 Days / Arm 1 | Part 1 + Part 2 - Serial Reduction of Optical Density Values Measured by Recombinant ELISA | Part 2 - Year 3 (FU Visit 3) | 2.17 Optical density | Standard Deviation 0.98 |
| Nifurtimox 60 Days / Arm 1 | Part 1 + Part 2 - Serial Reduction of Optical Density Values Measured by Recombinant ELISA | Part 2 - Year 2: (FU Visit 1) | 2.5 Optical density | Standard Deviation 0.95 |
| Nifurtimox 60 Days / Arm 1 | Part 1 + Part 2 - Serial Reduction of Optical Density Values Measured by Recombinant ELISA | Part 2 - Year 3: Change from Baseline (FU Visit 3) | -0.56 Optical density | Standard Deviation 0.86 |
| Nifurtimox 60 Days / Arm 1 | Part 1 + Part 2 - Serial Reduction of Optical Density Values Measured by Recombinant ELISA | Part 1 - Change from Baseline (Visit 11) | -0.47 Optical density | Standard Deviation 0.74 |
| Nifurtimox 60 Days / Arm 1 | Part 1 + Part 2 - Serial Reduction of Optical Density Values Measured by Recombinant ELISA | Part 2 - Year 4 (FU Visit 5) | 2.09 Optical density | Standard Deviation 1.01 |
| Nifurtimox 60 Days / Arm 1 | Part 1 + Part 2 - Serial Reduction of Optical Density Values Measured by Recombinant ELISA | Part 2 - Year 2: Change from Baseline (FU Visit 1) | -0.23 Optical density | Standard Deviation 0.87 |
| Nifurtimox 60 Days / Arm 1 | Part 1 + Part 2 - Serial Reduction of Optical Density Values Measured by Recombinant ELISA | Part 2 - Year 4: Change from Baseline (FU Visit 5) | -0.64 Optical density | Standard Deviation 0.89 |
| Nifurtimox 60 Days / Arm 1 | Part 1 + Part 2 - Serial Reduction of Optical Density Values Measured by Recombinant ELISA | Part 1 - Baseline (Visit 1) | 2.74 Optical density | Standard Deviation 0.63 |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 + Part 2 - Serial Reduction of Optical Density Values Measured by Recombinant ELISA | Part 2 - Year 4: Change from Baseline (FU Visit 5) | -0.48 Optical density | Standard Deviation 0.87 |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 + Part 2 - Serial Reduction of Optical Density Values Measured by Recombinant ELISA | Part 1 - Baseline (Visit 1) | 2.73 Optical density | Standard Deviation 0.63 |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 + Part 2 - Serial Reduction of Optical Density Values Measured by Recombinant ELISA | Part 1 - Up to 420 days post-treatment (Visit 11) | 2.31 Optical density | Standard Deviation 1 |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 + Part 2 - Serial Reduction of Optical Density Values Measured by Recombinant ELISA | Part 1 - Change from Baseline (Visit 11) | -0.41 Optical density | Standard Deviation 0.79 |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 + Part 2 - Serial Reduction of Optical Density Values Measured by Recombinant ELISA | Part 2 - Year 2: (FU Visit 1) | 2.57 Optical density | Standard Deviation 0.88 |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 + Part 2 - Serial Reduction of Optical Density Values Measured by Recombinant ELISA | Part 2 - Year 2: Change from Baseline (FU Visit 1) | -0.17 Optical density | Standard Deviation 0.9 |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 + Part 2 - Serial Reduction of Optical Density Values Measured by Recombinant ELISA | Part 2 - Year 3 (FU Visit 3) | 2.25 Optical density | Standard Deviation 0.91 |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 + Part 2 - Serial Reduction of Optical Density Values Measured by Recombinant ELISA | Part 2 - Year 3: Change from Baseline (FU Visit 3) | -0.45 Optical density | Standard Deviation 0.87 |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 + Part 2 - Serial Reduction of Optical Density Values Measured by Recombinant ELISA | Part 2 - Year 4 (FU Visit 5) | 2.22 Optical density | Standard Deviation 1 |
Secondary
Part 1 + Part 2 - Serial Reduction of Optical Density Values Measured by Total Purified Antigen ELISA
Summary and change from baseline of optical density values measured by total purified antigen ELISA. Optical density is the measure of absorbance, and is defined as the ratio of the intensity of light falling upon a material and the intensity transmitted.
Time frame: Baseline and Subjects participating in Part 2 were followed up for another 3 years, for a total follow-up period of 4 years after end of nifurtimox treatment in Part 1
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nifurtimox 60 Days / Arm 1 | Part 1 + Part 2 - Serial Reduction of Optical Density Values Measured by Total Purified Antigen ELISA | Part 1 - Up to 420 days post-treatment (Visit 11) | 1.24 Optical density | Standard Deviation 0.62 |
| Nifurtimox 60 Days / Arm 1 | Part 1 + Part 2 - Serial Reduction of Optical Density Values Measured by Total Purified Antigen ELISA | Part 2 - Year 3 (FU Visit 3) | 1.16 Optical density | Standard Deviation 0.58 |
| Nifurtimox 60 Days / Arm 1 | Part 1 + Part 2 - Serial Reduction of Optical Density Values Measured by Total Purified Antigen ELISA | Part 2 - Year 2: (FU Visit 1) | 1.23 Optical density | Standard Deviation 0.59 |
| Nifurtimox 60 Days / Arm 1 | Part 1 + Part 2 - Serial Reduction of Optical Density Values Measured by Total Purified Antigen ELISA | Part 2 - Year 3: Change from Baseline (FU Visit 3) | -0.30 Optical density | Standard Deviation 0.42 |
| Nifurtimox 60 Days / Arm 1 | Part 1 + Part 2 - Serial Reduction of Optical Density Values Measured by Total Purified Antigen ELISA | Part 1 - Change from Baseline (Visit 11) | -0.24 Optical density | Standard Deviation 0.29 |
| Nifurtimox 60 Days / Arm 1 | Part 1 + Part 2 - Serial Reduction of Optical Density Values Measured by Total Purified Antigen ELISA | Part 2 - Year 4 (FU Visit 5) | 1.12 Optical density | Standard Deviation 0.57 |
| Nifurtimox 60 Days / Arm 1 | Part 1 + Part 2 - Serial Reduction of Optical Density Values Measured by Total Purified Antigen ELISA | Part 2 - Year 2: Change from Baseline (FU Visit 1) | -0.25 Optical density | Standard Deviation 0.41 |
| Nifurtimox 60 Days / Arm 1 | Part 1 + Part 2 - Serial Reduction of Optical Density Values Measured by Total Purified Antigen ELISA | Part 2 - Year 4: Change from Baseline (FU Visit 5) | -0.35 Optical density | Standard Deviation 0.4 |
| Nifurtimox 60 Days / Arm 1 | Part 1 + Part 2 - Serial Reduction of Optical Density Values Measured by Total Purified Antigen ELISA | Part 1 - Baseline (Visit 1) | 1.47 Optical density | Standard Deviation 0.55 |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 + Part 2 - Serial Reduction of Optical Density Values Measured by Total Purified Antigen ELISA | Part 2 - Year 4: Change from Baseline (FU Visit 5) | -0.30 Optical density | Standard Deviation 0.46 |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 + Part 2 - Serial Reduction of Optical Density Values Measured by Total Purified Antigen ELISA | Part 1 - Baseline (Visit 1) | 1.52 Optical density | Standard Deviation 0.55 |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 + Part 2 - Serial Reduction of Optical Density Values Measured by Total Purified Antigen ELISA | Part 1 - Up to 420 days post-treatment (Visit 11) | 1.30 Optical density | Standard Deviation 0.61 |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 + Part 2 - Serial Reduction of Optical Density Values Measured by Total Purified Antigen ELISA | Part 1 - Change from Baseline (Visit 11) | -0.23 Optical density | Standard Deviation 0.41 |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 + Part 2 - Serial Reduction of Optical Density Values Measured by Total Purified Antigen ELISA | Part 2 - Year 2: (FU Visit 1) | 1.29 Optical density | Standard Deviation 0.61 |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 + Part 2 - Serial Reduction of Optical Density Values Measured by Total Purified Antigen ELISA | Part 2 - Year 2: Change from Baseline (FU Visit 1) | -0.23 Optical density | Standard Deviation 0.49 |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 + Part 2 - Serial Reduction of Optical Density Values Measured by Total Purified Antigen ELISA | Part 2 - Year 3 (FU Visit 3) | 1.23 Optical density | Standard Deviation 0.58 |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 + Part 2 - Serial Reduction of Optical Density Values Measured by Total Purified Antigen ELISA | Part 2 - Year 3: Change from Baseline (FU Visit 3) | -0.30 Optical density | Standard Deviation 0.5 |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 + Part 2 - Serial Reduction of Optical Density Values Measured by Total Purified Antigen ELISA | Part 2 - Year 4 (FU Visit 5) | 1.23 Optical density | Standard Deviation 0.59 |
Secondary
Part 2 - ECG Signs of Established Chagas-related Cardiomyopathy
Summary of subjects by evidence of established Chagas-related cardiomyopathy as measured by electrocardiogram (ECG). Evidence of established Chagas-related cardiomyopathy: Total
Time frame: Subjects participating in Part 2 were followed up for another 3 years, for a total follow-up period of 4 years after end of nifurtimox treatment in Part 1
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nifurtimox 60 Days / Arm 1 | Part 2 - ECG Signs of Established Chagas-related Cardiomyopathy | YES | 0 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 2 - ECG Signs of Established Chagas-related Cardiomyopathy | NO | 189 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 2 - ECG Signs of Established Chagas-related Cardiomyopathy | MISSING | 8 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 2 - ECG Signs of Established Chagas-related Cardiomyopathy | YES | 0 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 2 - ECG Signs of Established Chagas-related Cardiomyopathy | NO | 90 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 2 - ECG Signs of Established Chagas-related Cardiomyopathy | MISSING | 8 Participants |
Secondary
Part 2 - Incidence Rate of Seronegative Conversion in Subjects Who Received at Least One Dose of the 30-day Nifurtimox Treatment Regimen
Seronegative conversion measured by two types of assay (recombinant ELISA and indirect hemagglutination assay \[IHA\]) in subjects who were randomized and received at least one dose of the 30-day nifurtimox treatment regimen. Incidence rate is the number of new cases of seronegative conversion over the study period (i.e., 4 years after end of nifurtimox treatment) divided by the person-time at risk. It was modelled using a Poisson distribution with a 2-sided 95% exact CI. Number of participants with events were reported.
Time frame: Subjects participating in Part 2 were followed up for another 3 years, for a total follow-up period of 4 years after end of nifurtimox treatment in Part 1
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nifurtimox 60 Days / Arm 1 | Part 2 - Incidence Rate of Seronegative Conversion in Subjects Who Received at Least One Dose of the 30-day Nifurtimox Treatment Regimen | 8 Participants |
95% CI: [0.91, 4.16]
Secondary
Part 2 - Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
TEAEs comprised events which first occurred or worsened at study start up to end of study in part 2. In Part 2, only AEs considered at least possibly related to nifurtimox (administered in part 1) and those caused by protocol-related procedures were reported.
Time frame: Subjects participating in Part 2 were followed up for another 3 years, for a total follow-up period of 4 years after end of nifurtimox treatment in Part 1
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nifurtimox 60 Days / Arm 1 | Part 2 - Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Any AE related to protocol | 0 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 2 - Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Any study drug-related SAE | 0 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 2 - Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Any study drug-related AE | 0 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 2 - Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Any SAE related to protocol | 0 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 2 - Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Any SAE | 0 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 2 - Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | AE with outcome death | 0 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 2 - Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Any AE | 0 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 2 - Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | AE with outcome death | 0 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 2 - Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Any AE | 0 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 2 - Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Any study drug-related AE | 0 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 2 - Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Any AE related to protocol | 0 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 2 - Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Any SAE | 0 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 2 - Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Any study drug-related SAE | 0 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 2 - Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Any SAE related to protocol | 0 Participants |
Secondary
Part 2 - Serological Response of Established Chagas-related Cardiomyopathy
Summary of subjects by evidence of established Chagas-related cardiomyopathy as measured by Serological response. Evidence of established Chagas-related cardiomyopathy: Total
Time frame: Subjects participating in Part 2 were followed up for another 3 years, for a total follow-up period of 4 years after end of nifurtimox treatment in Part 1
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nifurtimox 60 Days / Arm 1 | Part 2 - Serological Response of Established Chagas-related Cardiomyopathy | Non Reactive | 14 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 2 - Serological Response of Established Chagas-related Cardiomyopathy | Reactive | 176 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 2 - Serological Response of Established Chagas-related Cardiomyopathy | Missing | 7 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 2 - Serological Response of Established Chagas-related Cardiomyopathy | Non Reactive | 6 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 2 - Serological Response of Established Chagas-related Cardiomyopathy | Reactive | 84 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 2 - Serological Response of Established Chagas-related Cardiomyopathy | Missing | 8 Participants |
Other Pre-specified
Part 1: Number of Participants Cured With 60-day Regimen Compared With Historical Active Control (Benznidazole)
This exploratory efficacy analysis evaluated the cure rate assessed as seroconversion of nifurtimox after 1-year post-treatment follow-up with that of published data for benznidazole (Sosa Estani et al. 1998 and de Andrade et al. 1996) at 4- and 3-year post-treatment follow-up, respectively, used as historical control.
Time frame: Up to 420 days (Visit 11 post-treatment)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nifurtimox 60 Days / Arm 1 | Part 1: Number of Participants Cured With 60-day Regimen Compared With Historical Active Control (Benznidazole) | 10 Participants |
Other Pre-specified
Part 1 - Relationship Between Conventional ELISA Results in Terms of Cure or No Cure and IHA Results in All Patients
Cure is defined as sero-reduction (in subjects =\> 8 months to \< 18 years of age at randomization) or sero-conversion (in all subjects). Sero-reduction is defined as a =\> 20% reduction in optical density \[OD\]) measured by two conventional ELISA serology tests and sero-conversion is defined as negative Immunoglobulin G \[IgG\] concentration measured by two conventional ELISA serology tests. Cure = Cure Non reactive/reactive decreasing = Nonreac/reac dec Reactive non-decreasing = Reac nondec No cure = No Cure Missing IHA testing = IHA missing
Time frame: Up to 420 days (Visit 11 post-treatment)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nifurtimox 60 Days / Arm 1 | Part 1 - Relationship Between Conventional ELISA Results in Terms of Cure or No Cure and IHA Results in All Patients | Nifurtimox 60 days | 52 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Relationship Between Conventional ELISA Results in Terms of Cure or No Cure and IHA Results in All Patients | Nifurtimox 30 days | 17 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Relationship Between Conventional ELISA Results in Terms of Cure or No Cure and IHA Results in All Patients | Nifurtimox 60 days | 20 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Relationship Between Conventional ELISA Results in Terms of Cure or No Cure and IHA Results in All Patients | Nifurtimox 30 days | 4 Participants |
| Nifurtimox 60 Days Non-reactive Detectable | Part 1 - Relationship Between Conventional ELISA Results in Terms of Cure or No Cure and IHA Results in All Patients | Nifurtimox 60 days | 48 Participants |
| Nifurtimox 60 Days Non-reactive Detectable | Part 1 - Relationship Between Conventional ELISA Results in Terms of Cure or No Cure and IHA Results in All Patients | Nifurtimox 30 days | 29 Participants |
| Nifurtimox 60 Days Non-reactive Non-detectable | Part 1 - Relationship Between Conventional ELISA Results in Terms of Cure or No Cure and IHA Results in All Patients | Nifurtimox 30 days | 58 Participants |
| Nifurtimox 60 Days Non-reactive Non-detectable | Part 1 - Relationship Between Conventional ELISA Results in Terms of Cure or No Cure and IHA Results in All Patients | Nifurtimox 60 days | 89 Participants |
| Nifurtimox 60 Days Reactive Non Evaluable | Part 1 - Relationship Between Conventional ELISA Results in Terms of Cure or No Cure and IHA Results in All Patients | Nifurtimox 60 days | 1 Participants |
| Nifurtimox 60 Days Reactive Non Evaluable | Part 1 - Relationship Between Conventional ELISA Results in Terms of Cure or No Cure and IHA Results in All Patients | Nifurtimox 30 days | 0 Participants |
Other Pre-specified
Part 1 - Relationship of Conventional Serology (ELISA) to Indirect Hemagglutination Assay (IHA) Results
Sero-reduction is defined as a =\> 20% reduction in optical density \[OD\]) using two conventional ELISA serology tests in subjects =\> 8 months to \< 18 years of age at randomization; Others: reactive results that are not sero-reduction in subjects =\> 8 months to \< 18 years of age at randomization; or reactive results in subjects \< 8 months of age at randomization. Non-reactive ELISA = Nonreac ELISA Non-reactive IHA = Nonreac IHA Reactive IHA decrease = Reac IHA dec React IHA nochange = Reac IHA nochange Reactive ELISA: seroreduction = Reac ELISA reduc Reactive ELISA: others = Reac ELISA other
Time frame: Up to 420 days (Visit 11 post-treatment)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nifurtimox 60 Days / Arm 1 | Part 1 - Relationship of Conventional Serology (ELISA) to Indirect Hemagglutination Assay (IHA) Results | Nifurtimox 60 days | 8 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Relationship of Conventional Serology (ELISA) to Indirect Hemagglutination Assay (IHA) Results | Nifurtimox 30 days | 4 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Relationship of Conventional Serology (ELISA) to Indirect Hemagglutination Assay (IHA) Results | Nifurtimox 60 days | 2 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Relationship of Conventional Serology (ELISA) to Indirect Hemagglutination Assay (IHA) Results | Nifurtimox 30 days | 1 Participants |
| Nifurtimox 60 Days Non-reactive Detectable | Part 1 - Relationship of Conventional Serology (ELISA) to Indirect Hemagglutination Assay (IHA) Results | Nifurtimox 60 days | 0 Participants |
| Nifurtimox 60 Days Non-reactive Detectable | Part 1 - Relationship of Conventional Serology (ELISA) to Indirect Hemagglutination Assay (IHA) Results | Nifurtimox 30 days | 0 Participants |
| Nifurtimox 60 Days Non-reactive Non-detectable | Part 1 - Relationship of Conventional Serology (ELISA) to Indirect Hemagglutination Assay (IHA) Results | Nifurtimox 60 days | 2 Participants |
| Nifurtimox 60 Days Non-reactive Non-detectable | Part 1 - Relationship of Conventional Serology (ELISA) to Indirect Hemagglutination Assay (IHA) Results | Nifurtimox 30 days | 0 Participants |
| Nifurtimox 60 Days Reactive Non Evaluable | Part 1 - Relationship of Conventional Serology (ELISA) to Indirect Hemagglutination Assay (IHA) Results | Nifurtimox 30 days | 12 Participants |
| Nifurtimox 60 Days Reactive Non Evaluable | Part 1 - Relationship of Conventional Serology (ELISA) to Indirect Hemagglutination Assay (IHA) Results | Nifurtimox 60 days | 40 Participants |
| Nifurtimox 60 Days Reactive qPCR Missing | Part 1 - Relationship of Conventional Serology (ELISA) to Indirect Hemagglutination Assay (IHA) Results | Nifurtimox 30 days | 4 Participants |
| Nifurtimox 60 Days Reactive qPCR Missing | Part 1 - Relationship of Conventional Serology (ELISA) to Indirect Hemagglutination Assay (IHA) Results | Nifurtimox 60 days | 20 Participants |
| Nifurtimox 30 Days Reactive Detectable | Part 1 - Relationship of Conventional Serology (ELISA) to Indirect Hemagglutination Assay (IHA) Results | Nifurtimox 30 days | 1 Participants |
| Nifurtimox 30 Days Reactive Detectable | Part 1 - Relationship of Conventional Serology (ELISA) to Indirect Hemagglutination Assay (IHA) Results | Nifurtimox 60 days | 1 Participants |
| Nifurtimox 30 Days Reactive Non-detectable | Part 1 - Relationship of Conventional Serology (ELISA) to Indirect Hemagglutination Assay (IHA) Results | Nifurtimox 60 days | 47 Participants |
| Nifurtimox 30 Days Reactive Non-detectable | Part 1 - Relationship of Conventional Serology (ELISA) to Indirect Hemagglutination Assay (IHA) Results | Nifurtimox 30 days | 30 Participants |
| Nifurtimox 30 Days Non-reactive Detectable | Part 1 - Relationship of Conventional Serology (ELISA) to Indirect Hemagglutination Assay (IHA) Results | Nifurtimox 60 days | 89 Participants |
| Nifurtimox 30 Days Non-reactive Detectable | Part 1 - Relationship of Conventional Serology (ELISA) to Indirect Hemagglutination Assay (IHA) Results | Nifurtimox 30 days | 58 Participants |
| Nifurtimox 30 Days Non-reactive Non-detectable | Part 1 - Relationship of Conventional Serology (ELISA) to Indirect Hemagglutination Assay (IHA) Results | Nifurtimox 60 days | 1 Participants |
| Nifurtimox 30 Days Non-reactive Non-detectable | Part 1 - Relationship of Conventional Serology (ELISA) to Indirect Hemagglutination Assay (IHA) Results | Nifurtimox 30 days | 0 Participants |
Other Pre-specified
Part 1 - Relationship of Conventional Serology (Recombinant ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit
Using frequencies of matches and mismatches to assess agreement Reactive = Reac ELISA Reactive = Reac F29 Non-reactive = Nonreac ELISA Non-reactive= Nonreac F29
Time frame: Up to 420 days (Visit 11 post-treatment)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nifurtimox 60 Days / Arm 1 | Part 1 - Relationship of Conventional Serology (Recombinant ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 11 | 93 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Relationship of Conventional Serology (Recombinant ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 3 | 133 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Relationship of Conventional Serology (Recombinant ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 8 | 124 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Relationship of Conventional Serology (Recombinant ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 1 | 142 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Relationship of Conventional Serology (Recombinant ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 6 | 131 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Relationship of Conventional Serology (Recombinant ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 10 | 108 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Relationship of Conventional Serology (Recombinant ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 1 | 77 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Relationship of Conventional Serology (Recombinant ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 8 | 90 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Relationship of Conventional Serology (Recombinant ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 11 | 106 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Relationship of Conventional Serology (Recombinant ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 3 | 85 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Relationship of Conventional Serology (Recombinant ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 10 | 91 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Relationship of Conventional Serology (Recombinant ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 6 | 81 Participants |
| Nifurtimox 60 Days Non-reactive Detectable | Part 1 - Relationship of Conventional Serology (Recombinant ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 10 | 2 Participants |
| Nifurtimox 60 Days Non-reactive Detectable | Part 1 - Relationship of Conventional Serology (Recombinant ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 6 | 0 Participants |
| Nifurtimox 60 Days Non-reactive Detectable | Part 1 - Relationship of Conventional Serology (Recombinant ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 11 | 3 Participants |
| Nifurtimox 60 Days Non-reactive Detectable | Part 1 - Relationship of Conventional Serology (Recombinant ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 8 | 0 Participants |
| Nifurtimox 60 Days Non-reactive Detectable | Part 1 - Relationship of Conventional Serology (Recombinant ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 1 | 0 Participants |
| Nifurtimox 60 Days Non-reactive Detectable | Part 1 - Relationship of Conventional Serology (Recombinant ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 3 | 0 Participants |
| Nifurtimox 60 Days Non-reactive Non-detectable | Part 1 - Relationship of Conventional Serology (Recombinant ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 10 | 10 Participants |
| Nifurtimox 60 Days Non-reactive Non-detectable | Part 1 - Relationship of Conventional Serology (Recombinant ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 1 | 0 Participants |
| Nifurtimox 60 Days Non-reactive Non-detectable | Part 1 - Relationship of Conventional Serology (Recombinant ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 3 | 0 Participants |
| Nifurtimox 60 Days Non-reactive Non-detectable | Part 1 - Relationship of Conventional Serology (Recombinant ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 6 | 2 Participants |
| Nifurtimox 60 Days Non-reactive Non-detectable | Part 1 - Relationship of Conventional Serology (Recombinant ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 8 | 1 Participants |
| Nifurtimox 60 Days Non-reactive Non-detectable | Part 1 - Relationship of Conventional Serology (Recombinant ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 11 | 0 Participants |
| Nifurtimox 60 Days Reactive Non Evaluable | Part 1 - Relationship of Conventional Serology (Recombinant ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 8 | 63 Participants |
| Nifurtimox 60 Days Reactive Non Evaluable | Part 1 - Relationship of Conventional Serology (Recombinant ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 3 | 64 Participants |
| Nifurtimox 60 Days Reactive Non Evaluable | Part 1 - Relationship of Conventional Serology (Recombinant ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 10 | 59 Participants |
| Nifurtimox 60 Days Reactive Non Evaluable | Part 1 - Relationship of Conventional Serology (Recombinant ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 11 | 53 Participants |
| Nifurtimox 60 Days Reactive Non Evaluable | Part 1 - Relationship of Conventional Serology (Recombinant ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 6 | 67 Participants |
| Nifurtimox 60 Days Reactive Non Evaluable | Part 1 - Relationship of Conventional Serology (Recombinant ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 1 | 72 Participants |
| Nifurtimox 60 Days Reactive qPCR Missing | Part 1 - Relationship of Conventional Serology (Recombinant ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 6 | 0 Participants |
| Nifurtimox 60 Days Reactive qPCR Missing | Part 1 - Relationship of Conventional Serology (Recombinant ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 8 | 0 Participants |
| Nifurtimox 60 Days Reactive qPCR Missing | Part 1 - Relationship of Conventional Serology (Recombinant ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 3 | 0 Participants |
| Nifurtimox 60 Days Reactive qPCR Missing | Part 1 - Relationship of Conventional Serology (Recombinant ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 10 | 2 Participants |
| Nifurtimox 60 Days Reactive qPCR Missing | Part 1 - Relationship of Conventional Serology (Recombinant ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 1 | 0 Participants |
| Nifurtimox 60 Days Reactive qPCR Missing | Part 1 - Relationship of Conventional Serology (Recombinant ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 11 | 1 Participants |
| Nifurtimox 30 Days Reactive Detectable | Part 1 - Relationship of Conventional Serology (Recombinant ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 6 | 1 Participants |
| Nifurtimox 30 Days Reactive Detectable | Part 1 - Relationship of Conventional Serology (Recombinant ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 3 | 1 Participants |
| Nifurtimox 30 Days Reactive Detectable | Part 1 - Relationship of Conventional Serology (Recombinant ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 11 | 6 Participants |
| Nifurtimox 30 Days Reactive Detectable | Part 1 - Relationship of Conventional Serology (Recombinant ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 8 | 1 Participants |
| Nifurtimox 30 Days Reactive Detectable | Part 1 - Relationship of Conventional Serology (Recombinant ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 10 | 5 Participants |
| Nifurtimox 30 Days Reactive Detectable | Part 1 - Relationship of Conventional Serology (Recombinant ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 1 | 1 Participants |
Other Pre-specified
Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit
Using frequencies of matches and mismatches to assess agreement Reactive = Reac ELISA Reactive = Reac F29 Non-reactive = Nonreac ELISA Non-reactive = Nonreac F29
Time frame: Up to 420 days (Visit 11 post-treatment)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nifurtimox 60 Days / Arm 1 | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 11 | 93 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 1 | 142 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 3 | 133 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 6 | 131 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 10 | 108 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 8 | 124 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 6 | 83 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 1 | 77 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 8 | 91 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 11 | 106 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 3 | 85 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 10 | 92 Participants |
| Nifurtimox 60 Days Non-reactive Detectable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 10 | 2 Participants |
| Nifurtimox 60 Days Non-reactive Detectable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 6 | 0 Participants |
| Nifurtimox 60 Days Non-reactive Detectable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 3 | 0 Participants |
| Nifurtimox 60 Days Non-reactive Detectable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 8 | 0 Participants |
| Nifurtimox 60 Days Non-reactive Detectable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 11 | 3 Participants |
| Nifurtimox 60 Days Non-reactive Detectable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 1 | 0 Participants |
| Nifurtimox 60 Days Non-reactive Non-detectable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 10 | 9 Participants |
| Nifurtimox 60 Days Non-reactive Non-detectable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 1 | 0 Participants |
| Nifurtimox 60 Days Non-reactive Non-detectable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 3 | 0 Participants |
| Nifurtimox 60 Days Non-reactive Non-detectable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 6 | 0 Participants |
| Nifurtimox 60 Days Non-reactive Non-detectable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 8 | 63 Participants |
| Nifurtimox 60 Days Non-reactive Non-detectable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 11 | 8 Participants |
| Nifurtimox 60 Days Reactive Non Evaluable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 10 | 61 Participants |
| Nifurtimox 60 Days Reactive Non Evaluable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 3 | 64 Participants |
| Nifurtimox 60 Days Reactive Non Evaluable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 11 | 54 Participants |
| Nifurtimox 60 Days Reactive Non Evaluable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 1 | 72 Participants |
| Nifurtimox 60 Days Reactive Non Evaluable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 8 | 63 Participants |
| Nifurtimox 60 Days Reactive Non Evaluable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 6 | 67 Participants |
| Nifurtimox 60 Days Reactive qPCR Missing | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 6 | 42 Participants |
| Nifurtimox 60 Days Reactive qPCR Missing | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 8 | 43 Participants |
| Nifurtimox 60 Days Reactive qPCR Missing | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 3 | 43 Participants |
| Nifurtimox 60 Days Reactive qPCR Missing | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 10 | 42 Participants |
| Nifurtimox 60 Days Reactive qPCR Missing | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 1 | 38 Participants |
| Nifurtimox 60 Days Reactive qPCR Missing | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 11 | 48 Participants |
| Nifurtimox 30 Days Reactive Detectable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 8 | 0 Participants |
| Nifurtimox 30 Days Reactive Detectable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 10 | 0 Participants |
| Nifurtimox 30 Days Reactive Detectable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 1 | 0 Participants |
| Nifurtimox 30 Days Reactive Detectable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 6 | 0 Participants |
| Nifurtimox 30 Days Reactive Detectable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 11 | 0 Participants |
| Nifurtimox 30 Days Reactive Detectable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 3 | 0 Participants |
| Nifurtimox 30 Days Reactive Non-detectable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 8 | 1 Participants |
| Nifurtimox 30 Days Reactive Non-detectable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 6 | 1 Participants |
| Nifurtimox 30 Days Reactive Non-detectable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 11 | 6 Participants |
| Nifurtimox 30 Days Reactive Non-detectable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 10 | 6 Participants |
| Nifurtimox 30 Days Reactive Non-detectable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 1 | 1 Participants |
| Nifurtimox 30 Days Reactive Non-detectable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit | Visit 3 | 1 Participants |
Other Pre-specified
Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and qPCR Testing by Visit
Using frequencies of matches and mismatches to assess agreement Reactive = Reac ELISA Detectable = Detec qPCR Non-reactive = Nonreac ELISA Non-detectable = Nondetec qPCR Non evaluable = Noneval qPCR qPCR Missing = Miss qPCR Missing conventional testing = Miss ELISA
Time frame: Up to 420 days (Visit 11 post-treatment)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nifurtimox 60 Days / Arm 1 | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and qPCR Testing by Visit | Visit 10 | 3 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and qPCR Testing by Visit | Visit 8 | 3 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and qPCR Testing by Visit | Visit 11 | 3 Participants |
| Nifurtimox 60 Days / Arm 1 | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and qPCR Testing by Visit | Visit 1 | 117 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and qPCR Testing by Visit | Visit 8 | 210 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and qPCR Testing by Visit | Visit 1 | 99 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and qPCR Testing by Visit | Visit 10 | 195 Participants |
| Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and qPCR Testing by Visit | Visit 11 | 194 Participants |
| Nifurtimox 60 Days Non-reactive Detectable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and qPCR Testing by Visit | Visit 1 | 0 Participants |
| Nifurtimox 60 Days Non-reactive Detectable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and qPCR Testing by Visit | Visit 8 | 0 Participants |
| Nifurtimox 60 Days Non-reactive Detectable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and qPCR Testing by Visit | Visit 10 | 0 Participants |
| Nifurtimox 60 Days Non-reactive Detectable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and qPCR Testing by Visit | Visit 11 | 0 Participants |
| Nifurtimox 60 Days Non-reactive Non-detectable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and qPCR Testing by Visit | Visit 1 | 0 Participants |
| Nifurtimox 60 Days Non-reactive Non-detectable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and qPCR Testing by Visit | Visit 11 | 11 Participants |
| Nifurtimox 60 Days Non-reactive Non-detectable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and qPCR Testing by Visit | Visit 8 | 0 Participants |
| Nifurtimox 60 Days Non-reactive Non-detectable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and qPCR Testing by Visit | Visit 10 | 11 Participants |
| Nifurtimox 60 Days Reactive Non Evaluable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and qPCR Testing by Visit | Visit 8 | 2 Participants |
| Nifurtimox 60 Days Reactive Non Evaluable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and qPCR Testing by Visit | Visit 11 | 1 Participants |
| Nifurtimox 60 Days Reactive Non Evaluable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and qPCR Testing by Visit | Visit 10 | 2 Participants |
| Nifurtimox 60 Days Reactive Non Evaluable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and qPCR Testing by Visit | Visit 1 | 1 Participants |
| Nifurtimox 60 Days Reactive qPCR Missing | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and qPCR Testing by Visit | Visit 1 | 2 Participants |
| Nifurtimox 60 Days Reactive qPCR Missing | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and qPCR Testing by Visit | Visit 8 | 0 Participants |
| Nifurtimox 60 Days Reactive qPCR Missing | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and qPCR Testing by Visit | Visit 11 | 1 Participants |
| Nifurtimox 60 Days Reactive qPCR Missing | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and qPCR Testing by Visit | Visit 10 | 0 Participants |
| Nifurtimox 30 Days Reactive Detectable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and qPCR Testing by Visit | Visit 10 | 2 Participants |
| Nifurtimox 30 Days Reactive Detectable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and qPCR Testing by Visit | Visit 1 | 57 Participants |
| Nifurtimox 30 Days Reactive Detectable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and qPCR Testing by Visit | Visit 8 | 1 Participants |
| Nifurtimox 30 Days Reactive Detectable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and qPCR Testing by Visit | Visit 11 | 5 Participants |
| Nifurtimox 30 Days Reactive Non-detectable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and qPCR Testing by Visit | Visit 8 | 103 Participants |
| Nifurtimox 30 Days Reactive Non-detectable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and qPCR Testing by Visit | Visit 1 | 52 Participants |
| Nifurtimox 30 Days Reactive Non-detectable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and qPCR Testing by Visit | Visit 11 | 96 Participants |
| Nifurtimox 30 Days Reactive Non-detectable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and qPCR Testing by Visit | Visit 10 | 99 Participants |
| Nifurtimox 30 Days Non-reactive Detectable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and qPCR Testing by Visit | Visit 10 | 0 Participants |
| Nifurtimox 30 Days Non-reactive Detectable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and qPCR Testing by Visit | Visit 11 | 0 Participants |
| Nifurtimox 30 Days Non-reactive Detectable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and qPCR Testing by Visit | Visit 8 | 0 Participants |
| Nifurtimox 30 Days Non-reactive Detectable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and qPCR Testing by Visit | Visit 1 | 0 Participants |
| Nifurtimox 30 Days Non-reactive Non-detectable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and qPCR Testing by Visit | Visit 1 | 1 Participants |
| Nifurtimox 30 Days Non-reactive Non-detectable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and qPCR Testing by Visit | Visit 10 | 6 Participants |
| Nifurtimox 30 Days Non-reactive Non-detectable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and qPCR Testing by Visit | Visit 8 | 1 Participants |
| Nifurtimox 30 Days Non-reactive Non-detectable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and qPCR Testing by Visit | Visit 11 | 6 Participants |
| Nifurtimox 30 Days Reactive Non Evaluable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and qPCR Testing by Visit | Visit 8 | 2 Participants |
| Nifurtimox 30 Days Reactive Non Evaluable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and qPCR Testing by Visit | Visit 10 | 2 Participants |
| Nifurtimox 30 Days Reactive Non Evaluable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and qPCR Testing by Visit | Visit 1 | 1 Participants |
| Nifurtimox 30 Days Reactive Non Evaluable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and qPCR Testing by Visit | Visit 11 | 1 Participants |
| Nifurtimox 30 Days Missing Conventional Testing Non-detectable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and qPCR Testing by Visit | Visit 1 | 0 Participants |
| Nifurtimox 30 Days Missing Conventional Testing Non-detectable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and qPCR Testing by Visit | Visit 10 | 0 Participants |
| Nifurtimox 30 Days Missing Conventional Testing Non-detectable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and qPCR Testing by Visit | Visit 8 | 1 Participants |
| Nifurtimox 30 Days Missing Conventional Testing Non-detectable | Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and qPCR Testing by Visit | Visit 11 | 0 Participants |