Candidemia
Conditions
Keywords
Anidulafungin, pediatrics, candidemia, invasive candidiasis, safety
Brief summary
Prospective, open label study to assess the pharmacokinetics, safety & efficacy of anidulafungin when used to treat children (aged 1 month - \<18 years) with invasive candidiasis, including candidemia (ICC).
Detailed description
Prospective, open label study to assess the pharmacokinetics, safety & efficacy of anidulafungin when used to treat children (aged 1 month - \< 18 years) with invasive candidiasis, including candidemia (ICC). To participate in the study, at the time of enrollment subjects must (1) have either a confirmed diagnosis of ICC or mycological evidence highly suggestive of Candida sp or (2) in infants 1 month to \< 2 years only, be at high risk of candidiasis. All subjects meeting screening criteria receive IV anidulafungin. Subjects will be stratified by age (1 month - \< 2 years; 2 years - \< 5 years; 5 years - \< 18 years). Subjects may be switched to oral fluconazole, provided that the pre-specified criteria are met. Subjects with microbiologically confirmed ICC must have a minimum total treatment duration of 14 days. The maximum allowed treatment duration of anidulafungin is 35 days; the maximum total treatment duration for the study is 49 days. At selected centers, anidulafungin pharmacokinetics will be assessed in the first 6 subjects age 1 month - \< 2 years to confirm the recommended dosage regimen. A population PK-PD analysis will be performed in all other enrolled subjects. Subjects will be followed for safety through 6 week FU visit. Efficacy for subjects with confirmed ICC will be assessed at EOIVT, EOT, 2-week FU and 6-week FU visits.
Interventions
DRUGAnidulafungin
Day 1: loading dose of 3 mg/kg (not to exceed 200 mg) Day 2 onwards: maintain a dose of 1.5 mg/kg (not to exceed 100 mg). Minimum total treatment duration is 14 days. Minimum IV anidulafungin treatment duration is 10 days for subjects with microbiologically confirmed ICC and 5 days for subjects at risk of candidiasis; followed by oral fluconazole 6-12 mg/kg/day (not to exceed 800mg/day). Maximum treatment duration with anidulafungin is 35 days.
DRUGFluconazole
Subjects may be switched to oral fluconazole \[6-12 mg/kg/day (not to exceed 800mg/day\] provided they meet specified criteria. Maximum total treatment duration is 49 days.
Sponsors
Pfizer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Months to 17 Years
Healthy volunteers
No
Inclusion criteria
* Subject must be either (1) at high risk for candidiasis (1 month - \< 2 years ONLY) or (2) have a definitive diagnosis of invasive candidiasis/candidemia (ICC) (All age groups) * Male and female patients from 1 month to less than 18 years of age.
Exclusion criteria
* Any patients with allergy to the drug; and any pregnant female or lactating. * Failed previous antifungal therapy or expected to live \< 3 days. * Patients with documented or suspected Candida meningitis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to 6 weeks after EOT (up to 91 days) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 6 weeks after end of treatment (EOT) (up to 91 days) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs. EOT visit defined as last day of study treatment (IV or oral). |
| Number of Participants With Laboratory Abnormalities | Baseline up to 6 weeks after EOT (up to 91 days) | Criteria for laboratory abnormalities: Hematology parameters: red blood cell count: \<0.8\*lower limit of normal (LLN); reticulocytes count (absolute or percent): \<0.5\*LLN or greater than (\>) 1.5\*upper limit of normal (ULN); Platelets: \<0.5\*LLN or \>1.75\*ULN; white blood cell count: \<0.6\*LLN or \>1.5\*ULN; neutrophils (absolute or percent): \<0.8\*LLN or \>1.2\*ULN; basophils (absolute or percent): \>1.2\*ULN; lymphocytes (absolute or percent): \<0.8\*LLN or \>1.2\*ULN; monocytes (absolute or percent): \>1.2\*ULN. Serum Chemistry parameters: sodium: \<0.95\*LLN or \>1.05\*ULN, potassium, chloride, bicarbonate, calcium: \<0.9\*LLN or \>1.1\*ULN; magnesium: \>1.1\*ULN or \<0.9\*LLN; BUN (blood urea nitrogen): \>1.3\* ULN, creatinine: \>1.3\*ULN; aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase : \>3.0\*ULN ; total bilirubin: \>1.5\*ULN; albumin: \<0.8\*LLN or \>1.2\*ULN and glucose: \<0.6\*LLN or \>1.5\*ULN.EOT visit defined as last day of study treatment (IV or oral). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of Anidulafungin for Pharmacokinetic (PK) Subgroup | Day 2: Just prior to the start of infusion, 2 minutes before the end of infusion, 6, 12, and 24 hours after the start of infusion | Cmax was obtained directly from the observed concentration data on Day 2. |
| Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours (AUC24) of Polysorbate 80 (PS 80) Following Infusion of Anidulafungin for PK Subgroup | Day 1: 0 to 2 hours post dose; Day 3 and Day 9:pre-dose; Day 5: 0 to 3 hours post dose; Day 7: 6 to 12 hours and 24 hours delayed post-dose | Excipient PS 80 is a solubilizing agent contained in the IV formulation of anidulafungin. The lower limit of quantitation (LLOQ) for all the observations of PS 80 was 5.0 microgram per milliliter (mcg/mL). PK time points were assessed on Day 1, Day 3, Day 5, Day 7 and Day 9. Summarized data for all the time points was reported. |
| Maximum Plasma Concentration (Cmax) of Polysorbate 80 (PS 80) Following Infusion of Anidulafungin for PK Subgroup | Day 1: 0 to 2 hours post dose; Day 3 and Day 9:pre-dose; Day 5: 0 to 3 hours post dose; Day 7: 6 to 12 hours delayed post-dose | Excipient PS 80 is a solubilizing agent contained in the IV formulation of anidulafungin. The lower limit of quantitation (LLOQ) for all the observations of PS 80 was 5.0 mcg/ml. PK time points were assessed on at Day 1, Day 3, Day 5, Day 7 and Day 9. Summarized data for all the time points was reported. |
| Estimated Area Under the Plasma Curve Over a 24-Hour Dosing Interval at Steady State (AUC0-24ss) of Anidulafungin | Sparse Sampling:Day 1:0-2 hr after end of infusion (EOI); Day3&9:pre-dose;Day 5:0-3hr post EOI; Day 7:6-12hr after EOI.For 1st 6 infants:< 2 years:Day 1:2 minutes before EOI; Day 2:pre infusion, 2 minutes before EOI, 6, 12,24 hours after start of infusion | AUC24 values were calculated using the individual parameter estimates obtained from the final population PK model. PK time points were assessed on Days 1-3, Day 5, Day 7, and Day 9. Data for all time points were included in the model. |
| Estimated Minimum Plasma Concentration (Cmin) of Anidulafungin | Sparse Sampling:Day 1:0-2 hr after end of infusion (EOI); Day3&9:pre-dose;Day 5:0-3hr post EOI; Day 7:6-12hr after EOI.For 1st 6 infants:< 2 years:Day 1:2 minutes before EOI; Day 2:pre infusion, 2 minutes before EOI, 6, 12,24 hours after start of infusion | Cmin values were calculated using the individual parameter estimates obtained from the final population PK model. PK time points were assessed on Days 1-3, Day 5, Day 7, and Day 9. Data for all time points were included in the model. |
| Number of Participants With Global Response | End of intravenous treatment (EOIVT) (maximum of 35 days), EOT (maximum of 49 days), during 2 week follow-up after EOT (up to 63 days) and during 6 week follow-up after EOT (up to 91 days) | Global response categorized: success, failure, indeterminate.Success:clinical response(CR) of cure(resolution of sign, symptoms attributed to Candida infection\[CI\]; no additional systemic/oral antifungal) or improvement (significant but incomplete resolution of signs symptoms of CI; no additional systemic antifungal) and microbiological eradication/presumed eradication(Baseline pathogen not isolated from original site culture/culture data not available for participant with successful outcome).Failure:CR of failure(no significant improvement in signs symptoms/ death due to CI)and/or microbiological failure(persistence/new infection at follow-up/relapse of infection at follow-up). Indeterminate:CR of indeterminate(evaluation not made or failure assessment)and/or microbiological response of indeterminate(Culture data not available for participant with clinical outcome of indeterminate) and neither response was failure.EOT visit:last day of study treatment (IV or oral). |
| Number of Participants With Greater Than or Equal to 1 Gastro-Intestinal (GI) Adverse Event Categorized on the Basis of Exposure to Anidulafungin (AUC0-24,ss) | Baseline to EOIVT (maximum of 35 days) | The probability of having at least one GI adverse event whilst on Anidulafungin treatment was compared with AUC0-24,ss quantile. Individual parameter estimates from the final PK model were used for estimation of Anidulafungin exposures. |
| Percentage of Participants With Global Response Categorized on the Basis of Exposure to Anidulafungin (AUC0-24,ss) | EOIVT (maximum of 35 days) and EOT (maximum of 49 days) | The probabilities of a global response of success or failure were compared with AUC0-24,ss quantile. Individual parameter estimates from the final PK model were used for estimation of Anidulafungin exposures. For the analysis of this outcome measure, global response was categorized as: success or failure. Success defined as clinical response (CR) of cure (resolution of signs, symptoms attributed to Candida infection \[CI\]). Failure defined as CR of failure (no significant improvement in signs symptoms/ death due to CI) and/or microbiological failure (persistence/new infection at follow-up/relapse of infection at follow-up). |
| Percentage of Participants With Relapsed Response | During 2 week follow-up after EOT (up to 63 days) and during 6 week follow-up after EOT (up to 91 days) | Relapse was defined as any baseline Candida species isolated following eradication (documented or presumed); or culture data not available for a participant with a clinical response of failure after a previous response of success. Clinical response of failure was defined as no significant improvement in signs and symptoms, or death due to the Candida infection. Participants had received at least 3 doses of study medication to be classified as a failure. Clinical response of success was defined as resolution of sign and symptoms attributed to Candida infection occurred with no additional systemic or oral antifungal treatment required to complete the course of therapy. Eradication or presumed eradication: baseline pathogen not isolated from original site culture(s), or culture data are not available for a participant with successful clinical outcome. End of treatment visit defined as last day of study treatment (IV or oral). |
| Percentage of Participants With New Infection | During 2 week follow-up (up to 63 days) and 6 week follow-up (up to 91 days) after EOT | New infection was defined as a participant presenting with clinical failure with the emergence of new Candida species at the original site of infection or at a distant site of infection. Clinical response of failure was defined as no significant improvement in signs and symptoms, or death due to the Candida infection occurred. Participants had received at least 3 doses of study medication to be classified as a failure. End of treatment visit defined as last day of study treatment (IV or oral). |
| All-Cause Mortality - Number of Participants Who Died During Overall Study Treatment Period and Follow-Up Visits | Overall treatment period (up to 49 days); during 2 week follow-up after EOT (up to 63 days) and during 6 week follow-up after EOT (up to 91 days) | — |
| Number of Participants With Greater Than or Equal to 1 Hepatic Adverse Event Categorized on the Basis of Exposure to Anidulafungin (AUC0-24,ss) | Baseline to End of intravenous treatment (EOIVT) (maximum of 35 days) | The probability of having at least one hepatic adverse event was compared with AUC0-24,ss quantile. Individual parameter estimates from the final PK model were used for estimation of Anidulafungin exposures. |
| Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours (AUC24) of Anidulafungin for Pharmacokinetic (PK) Subgroup | Day 2: Just prior to the start of infusion, 2 minutes before the end of infusion, 6, 12 and 24 hours after the start of infusion | Non-compartmental PK analysis was performed on individual plasma anidulafungin concentration-time data collected by serial sampling from participants in the PK sub-study. AUC24 was calculated based on the trapezoidal rule. |
Countries
Brazil, Canada, Greece, Italy, Russia, South Korea, Spain, Taiwan, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years Participants received Anidulafungin loading dose of 3 milligrams per kg(mg/kg) intravenously(IV) on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After \>=10 days treatment, participants with microbiologically confirmed invasive candidiasis/candidemia(ICC) and who fulfilled protocol specified criteria \[1)afebrile for \>=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures \[24 hours apart\] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection\] and after \>=5 days treatment, participants without microbiologically confirmed ICC,could switch to oral fluconazole(6-12 mg/kg/day,maximum 800mg/day) upto 49 days. First 6 participants received second antifungal agent, if required at Investigator's discretion. | 19 |
| Anidulafungin: Participants Aged 2 to <5 Years Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After \>=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria \[1)afebrile for \>=24 2hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures \[24 hours apart\] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection\] and after \>=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) for upto 49 days. | 19 |
| Anidulafungin: Participants Aged 5 to <18 Years Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After \>=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria (\[1)afebrile for \>=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures \[24 hours apart\] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection\]and after \>=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) upto 49 days. | 30 |
| Total | 68 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 1 | 2 | 5 |
| Overall Study | Lost to Follow-up | 0 | 0 | 1 |
| Overall Study | Randomized but not treated | 1 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years | Anidulafungin: Participants Aged 2 to <5 Years | Anidulafungin: Participants Aged 5 to <18 Years | Total |
|---|---|---|---|---|
| Age, Continuous | 0.93 years STANDARD_DEVIATION 0.52 | 3.09 years STANDARD_DEVIATION 0.68 | 10.67 years STANDARD_DEVIATION 3.68 | 5.83 years STANDARD_DEVIATION 5.05 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 4 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 6 Participants | 7 Participants |
| Race (NIH/OMB) White | 19 Participants | 15 Participants | 20 Participants | 54 Participants |
| Sex: Female, Male Female | 9 Participants | 8 Participants | 13 Participants | 30 Participants |
| Sex: Female, Male Male | 10 Participants | 11 Participants | 17 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 19 | 2 / 19 | 5 / 30 |
| other Total, other adverse events | 17 / 19 | 17 / 19 | 30 / 30 |
| serious Total, serious adverse events | 7 / 19 | 10 / 19 | 13 / 30 |
Outcome results
Primary
Number of Participants With Laboratory Abnormalities
Criteria for laboratory abnormalities: Hematology parameters: red blood cell count: \<0.8\*lower limit of normal (LLN); reticulocytes count (absolute or percent): \<0.5\*LLN or greater than (\>) 1.5\*upper limit of normal (ULN); Platelets: \<0.5\*LLN or \>1.75\*ULN; white blood cell count: \<0.6\*LLN or \>1.5\*ULN; neutrophils (absolute or percent): \<0.8\*LLN or \>1.2\*ULN; basophils (absolute or percent): \>1.2\*ULN; lymphocytes (absolute or percent): \<0.8\*LLN or \>1.2\*ULN; monocytes (absolute or percent): \>1.2\*ULN. Serum Chemistry parameters: sodium: \<0.95\*LLN or \>1.05\*ULN, potassium, chloride, bicarbonate, calcium: \<0.9\*LLN or \>1.1\*ULN; magnesium: \>1.1\*ULN or \<0.9\*LLN; BUN (blood urea nitrogen): \>1.3\* ULN, creatinine: \>1.3\*ULN; aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase : \>3.0\*ULN ; total bilirubin: \>1.5\*ULN; albumin: \<0.8\*LLN or \>1.2\*ULN and glucose: \<0.6\*LLN or \>1.5\*ULN.EOT visit defined as last day of study treatment (IV or oral).
Time frame: Baseline up to 6 weeks after EOT (up to 91 days)
Population: The safety population included all randomized participants who received at least 1 dose of study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years | Number of Participants With Laboratory Abnormalities | 19 Participants |
| Anidulafungin: Participants Aged 2 to <5 Years | Number of Participants With Laboratory Abnormalities | 18 Participants |
| Anidulafungin: Participants Aged 5 to <18 Years | Number of Participants With Laboratory Abnormalities | 30 Participants |
Primary
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 6 weeks after end of treatment (EOT) (up to 91 days) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs. EOT visit defined as last day of study treatment (IV or oral).
Time frame: Baseline up to 6 weeks after EOT (up to 91 days)
Population: The safety population included all randomized participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 17 Participants |
| Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 7 Participants |
| Anidulafungin: Participants Aged 2 to <5 Years | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 19 Participants |
| Anidulafungin: Participants Aged 2 to <5 Years | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 10 Participants |
| Anidulafungin: Participants Aged 5 to <18 Years | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 30 Participants |
| Anidulafungin: Participants Aged 5 to <18 Years | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 13 Participants |
Secondary
All-Cause Mortality - Number of Participants Who Died During Overall Study Treatment Period and Follow-Up Visits
Time frame: Overall treatment period (up to 49 days); during 2 week follow-up after EOT (up to 63 days) and during 6 week follow-up after EOT (up to 91 days)
Population: The safety population included all randomized participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years | All-Cause Mortality - Number of Participants Who Died During Overall Study Treatment Period and Follow-Up Visits | 2 Week Follow-up | 0 Participants |
| Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years | All-Cause Mortality - Number of Participants Who Died During Overall Study Treatment Period and Follow-Up Visits | overall study treatment period | 0 Participants |
| Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years | All-Cause Mortality - Number of Participants Who Died During Overall Study Treatment Period and Follow-Up Visits | 6 Week Follow-up | 1 Participants |
| Anidulafungin: Participants Aged 2 to <5 Years | All-Cause Mortality - Number of Participants Who Died During Overall Study Treatment Period and Follow-Up Visits | 2 Week Follow-up | 0 Participants |
| Anidulafungin: Participants Aged 2 to <5 Years | All-Cause Mortality - Number of Participants Who Died During Overall Study Treatment Period and Follow-Up Visits | overall study treatment period | 1 Participants |
| Anidulafungin: Participants Aged 2 to <5 Years | All-Cause Mortality - Number of Participants Who Died During Overall Study Treatment Period and Follow-Up Visits | 6 Week Follow-up | 1 Participants |
| Anidulafungin: Participants Aged 5 to <18 Years | All-Cause Mortality - Number of Participants Who Died During Overall Study Treatment Period and Follow-Up Visits | overall study treatment period | 4 Participants |
| Anidulafungin: Participants Aged 5 to <18 Years | All-Cause Mortality - Number of Participants Who Died During Overall Study Treatment Period and Follow-Up Visits | 6 Week Follow-up | 0 Participants |
| Anidulafungin: Participants Aged 5 to <18 Years | All-Cause Mortality - Number of Participants Who Died During Overall Study Treatment Period and Follow-Up Visits | 2 Week Follow-up | 1 Participants |
Secondary
Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours (AUC24) of Anidulafungin for Pharmacokinetic (PK) Subgroup
Non-compartmental PK analysis was performed on individual plasma anidulafungin concentration-time data collected by serial sampling from participants in the PK sub-study. AUC24 was calculated based on the trapezoidal rule.
Time frame: Day 2: Just prior to the start of infusion, 2 minutes before the end of infusion, 6, 12 and 24 hours after the start of infusion
Population: PK subgroup population included the first 6 participants aged between 1 month to \<2 years.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years | Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours (AUC24) of Anidulafungin for Pharmacokinetic (PK) Subgroup | 66449.1 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 28 |
Secondary
Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours (AUC24) of Polysorbate 80 (PS 80) Following Infusion of Anidulafungin for PK Subgroup
Excipient PS 80 is a solubilizing agent contained in the IV formulation of anidulafungin. The lower limit of quantitation (LLOQ) for all the observations of PS 80 was 5.0 microgram per milliliter (mcg/mL). PK time points were assessed on Day 1, Day 3, Day 5, Day 7 and Day 9. Summarized data for all the time points was reported.
Time frame: Day 1: 0 to 2 hours post dose; Day 3 and Day 9:pre-dose; Day 5: 0 to 3 hours post dose; Day 7: 6 to 12 hours and 24 hours delayed post-dose
Population: The PK subgroup population for PS80 included the last eight participants aged between 1 month to \<2 years.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years | Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours (AUC24) of Polysorbate 80 (PS 80) Following Infusion of Anidulafungin for PK Subgroup | NA ng*hr/mL |
Secondary
Estimated Area Under the Plasma Curve Over a 24-Hour Dosing Interval at Steady State (AUC0-24ss) of Anidulafungin
AUC24 values were calculated using the individual parameter estimates obtained from the final population PK model. PK time points were assessed on Days 1-3, Day 5, Day 7, and Day 9. Data for all time points were included in the model.
Time frame: Sparse Sampling:Day 1:0-2 hr after end of infusion (EOI); Day3&9:pre-dose;Day 5:0-3hr post EOI; Day 7:6-12hr after EOI.For 1st 6 infants:< 2 years:Day 1:2 minutes before EOI; Day 2:pre infusion, 2 minutes before EOI, 6, 12,24 hours after start of infusion
Population: PK population included all those participants who had 1 or more PK samples available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years | Estimated Area Under the Plasma Curve Over a 24-Hour Dosing Interval at Steady State (AUC0-24ss) of Anidulafungin | 69.87 microgram*hour per milliliter(mcg*hr/ml) | Standard Deviation 17.65 |
| Anidulafungin: Participants Aged 2 to <5 Years | Estimated Area Under the Plasma Curve Over a 24-Hour Dosing Interval at Steady State (AUC0-24ss) of Anidulafungin | 82.81 microgram*hour per milliliter(mcg*hr/ml) | Standard Deviation 31.9 |
| Anidulafungin: Participants Aged 5 to <18 Years | Estimated Area Under the Plasma Curve Over a 24-Hour Dosing Interval at Steady State (AUC0-24ss) of Anidulafungin | 86.77 microgram*hour per milliliter(mcg*hr/ml) | Standard Deviation 31.12 |
Secondary
Estimated Minimum Plasma Concentration (Cmin) of Anidulafungin
Cmin values were calculated using the individual parameter estimates obtained from the final population PK model. PK time points were assessed on Days 1-3, Day 5, Day 7, and Day 9. Data for all time points were included in the model.
Time frame: Sparse Sampling:Day 1:0-2 hr after end of infusion (EOI); Day3&9:pre-dose;Day 5:0-3hr post EOI; Day 7:6-12hr after EOI.For 1st 6 infants:< 2 years:Day 1:2 minutes before EOI; Day 2:pre infusion, 2 minutes before EOI, 6, 12,24 hours after start of infusion
Population: PK population included all those participants who had 1 or more PK samples available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years | Estimated Minimum Plasma Concentration (Cmin) of Anidulafungin | 1.98 microgram per milliliter (mcg/ml) | Standard Deviation 0.58 |
| Anidulafungin: Participants Aged 2 to <5 Years | Estimated Minimum Plasma Concentration (Cmin) of Anidulafungin | 2.51 microgram per milliliter (mcg/ml) | Standard Deviation 1.11 |
| Anidulafungin: Participants Aged 5 to <18 Years | Estimated Minimum Plasma Concentration (Cmin) of Anidulafungin | 2.52 microgram per milliliter (mcg/ml) | Standard Deviation 0.96 |
Secondary
Maximum Plasma Concentration (Cmax) of Anidulafungin for Pharmacokinetic (PK) Subgroup
Cmax was obtained directly from the observed concentration data on Day 2.
Time frame: Day 2: Just prior to the start of infusion, 2 minutes before the end of infusion, 6, 12, and 24 hours after the start of infusion
Population: PK subgroup population included the first 6 participants aged between 1 month to \<2 years.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years | Maximum Plasma Concentration (Cmax) of Anidulafungin for Pharmacokinetic (PK) Subgroup | 5963.53 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 29 |
Secondary
Maximum Plasma Concentration (Cmax) of Polysorbate 80 (PS 80) Following Infusion of Anidulafungin for PK Subgroup
Excipient PS 80 is a solubilizing agent contained in the IV formulation of anidulafungin. The lower limit of quantitation (LLOQ) for all the observations of PS 80 was 5.0 mcg/ml. PK time points were assessed on at Day 1, Day 3, Day 5, Day 7 and Day 9. Summarized data for all the time points was reported.
Time frame: Day 1: 0 to 2 hours post dose; Day 3 and Day 9:pre-dose; Day 5: 0 to 3 hours post dose; Day 7: 6 to 12 hours delayed post-dose
Population: The PK subgroup population for PS80 included the last eight participants aged between 1 month to \<2 years.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years | Maximum Plasma Concentration (Cmax) of Polysorbate 80 (PS 80) Following Infusion of Anidulafungin for PK Subgroup | NA ng/mL |
Secondary
Number of Participants With Global Response
Global response categorized: success, failure, indeterminate.Success:clinical response(CR) of cure(resolution of sign, symptoms attributed to Candida infection\[CI\]; no additional systemic/oral antifungal) or improvement (significant but incomplete resolution of signs symptoms of CI; no additional systemic antifungal) and microbiological eradication/presumed eradication(Baseline pathogen not isolated from original site culture/culture data not available for participant with successful outcome).Failure:CR of failure(no significant improvement in signs symptoms/ death due to CI)and/or microbiological failure(persistence/new infection at follow-up/relapse of infection at follow-up). Indeterminate:CR of indeterminate(evaluation not made or failure assessment)and/or microbiological response of indeterminate(Culture data not available for participant with clinical outcome of indeterminate) and neither response was failure.EOT visit:last day of study treatment (IV or oral).
Time frame: End of intravenous treatment (EOIVT) (maximum of 35 days), EOT (maximum of 49 days), during 2 week follow-up after EOT (up to 63 days) and during 6 week follow-up after EOT (up to 91 days)
Population: The mITT population was defined as all participants who had received at least 1 dose of study drug and who had microbiological confirmation of Candida infection.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years | Number of Participants With Global Response | EOT | Success | 11 Participants |
| Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years | Number of Participants With Global Response | EOIVT | Failure | 2 Participants |
| Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years | Number of Participants With Global Response | EOIVT | Indeterminate | 3 Participants |
| Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years | Number of Participants With Global Response | EOIVT | Missing | 0 Participants |
| Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years | Number of Participants With Global Response | EOIVT | Success | 11 Participants |
| Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years | Number of Participants With Global Response | EOT | Failure | 2 Participants |
| Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years | Number of Participants With Global Response | EOT | Indeterminate | 3 Participants |
| Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years | Number of Participants With Global Response | EOT | Missing | 0 Participants |
| Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years | Number of Participants With Global Response | 2 week follow-up | Success | 11 Participants |
| Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years | Number of Participants With Global Response | 2 week follow-up | Failure | 2 Participants |
| Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years | Number of Participants With Global Response | 2 week follow-up | Indeterminate | 3 Participants |
| Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years | Number of Participants With Global Response | 2 week follow-up | Missing | 0 Participants |
| Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years | Number of Participants With Global Response | 6 week follow-up | Success | 11 Participants |
| Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years | Number of Participants With Global Response | 6 week follow-up | Failure | 2 Participants |
| Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years | Number of Participants With Global Response | 6 week follow-up | Indeterminate | 3 Participants |
| Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years | Number of Participants With Global Response | 6 week follow-up | Missing | 0 Participants |
| Anidulafungin: Participants Aged 2 to <5 Years | Number of Participants With Global Response | EOT | Failure | 1 Participants |
| Anidulafungin: Participants Aged 2 to <5 Years | Number of Participants With Global Response | EOT | Indeterminate | 3 Participants |
| Anidulafungin: Participants Aged 2 to <5 Years | Number of Participants With Global Response | EOT | Missing | 0 Participants |
| Anidulafungin: Participants Aged 2 to <5 Years | Number of Participants With Global Response | 6 week follow-up | Failure | 2 Participants |
| Anidulafungin: Participants Aged 2 to <5 Years | Number of Participants With Global Response | 2 week follow-up | Success | 13 Participants |
| Anidulafungin: Participants Aged 2 to <5 Years | Number of Participants With Global Response | 2 week follow-up | Failure | 1 Participants |
| Anidulafungin: Participants Aged 2 to <5 Years | Number of Participants With Global Response | 6 week follow-up | Missing | 2 Participants |
| Anidulafungin: Participants Aged 2 to <5 Years | Number of Participants With Global Response | 2 week follow-up | Indeterminate | 1 Participants |
| Anidulafungin: Participants Aged 2 to <5 Years | Number of Participants With Global Response | EOIVT | Success | 14 Participants |
| Anidulafungin: Participants Aged 2 to <5 Years | Number of Participants With Global Response | 6 week follow-up | Indeterminate | 2 Participants |
| Anidulafungin: Participants Aged 2 to <5 Years | Number of Participants With Global Response | EOIVT | Failure | 1 Participants |
| Anidulafungin: Participants Aged 2 to <5 Years | Number of Participants With Global Response | 2 week follow-up | Missing | 3 Participants |
| Anidulafungin: Participants Aged 2 to <5 Years | Number of Participants With Global Response | EOIVT | Indeterminate | 3 Participants |
| Anidulafungin: Participants Aged 2 to <5 Years | Number of Participants With Global Response | EOIVT | Missing | 0 Participants |
| Anidulafungin: Participants Aged 2 to <5 Years | Number of Participants With Global Response | EOT | Success | 14 Participants |
| Anidulafungin: Participants Aged 2 to <5 Years | Number of Participants With Global Response | 6 week follow-up | Success | 12 Participants |
| Anidulafungin: Participants Aged 5 to <18 Years | Number of Participants With Global Response | 2 week follow-up | Indeterminate | 0 Participants |
| Anidulafungin: Participants Aged 5 to <18 Years | Number of Participants With Global Response | EOT | Failure | 3 Participants |
| Anidulafungin: Participants Aged 5 to <18 Years | Number of Participants With Global Response | 6 week follow-up | Success | 20 Participants |
| Anidulafungin: Participants Aged 5 to <18 Years | Number of Participants With Global Response | EOIVT | Indeterminate | 7 Participants |
| Anidulafungin: Participants Aged 5 to <18 Years | Number of Participants With Global Response | EOT | Indeterminate | 6 Participants |
| Anidulafungin: Participants Aged 5 to <18 Years | Number of Participants With Global Response | 6 week follow-up | Missing | 4 Participants |
| Anidulafungin: Participants Aged 5 to <18 Years | Number of Participants With Global Response | EOIVT | Success | 20 Participants |
| Anidulafungin: Participants Aged 5 to <18 Years | Number of Participants With Global Response | EOT | Missing | 0 Participants |
| Anidulafungin: Participants Aged 5 to <18 Years | Number of Participants With Global Response | 2 week follow-up | Missing | 4 Participants |
| Anidulafungin: Participants Aged 5 to <18 Years | Number of Participants With Global Response | EOT | Success | 21 Participants |
| Anidulafungin: Participants Aged 5 to <18 Years | Number of Participants With Global Response | 2 week follow-up | Success | 22 Participants |
| Anidulafungin: Participants Aged 5 to <18 Years | Number of Participants With Global Response | 6 week follow-up | Failure | 6 Participants |
| Anidulafungin: Participants Aged 5 to <18 Years | Number of Participants With Global Response | EOIVT | Failure | 3 Participants |
| Anidulafungin: Participants Aged 5 to <18 Years | Number of Participants With Global Response | 2 week follow-up | Failure | 4 Participants |
| Anidulafungin: Participants Aged 5 to <18 Years | Number of Participants With Global Response | EOIVT | Missing | 0 Participants |
| Anidulafungin: Participants Aged 5 to <18 Years | Number of Participants With Global Response | 6 week follow-up | Indeterminate | 0 Participants |
Secondary
Number of Participants With Greater Than or Equal to 1 Gastro-Intestinal (GI) Adverse Event Categorized on the Basis of Exposure to Anidulafungin (AUC0-24,ss)
The probability of having at least one GI adverse event whilst on Anidulafungin treatment was compared with AUC0-24,ss quantile. Individual parameter estimates from the final PK model were used for estimation of Anidulafungin exposures.
Time frame: Baseline to EOIVT (maximum of 35 days)
Population: Analysis performed on all participants who received at least one dose of the study treatment (Anidulafungin) and had estimable exposure parameters available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years | Number of Participants With Greater Than or Equal to 1 Gastro-Intestinal (GI) Adverse Event Categorized on the Basis of Exposure to Anidulafungin (AUC0-24,ss) | 5 Participants |
| Anidulafungin: Participants Aged 2 to <5 Years | Number of Participants With Greater Than or Equal to 1 Gastro-Intestinal (GI) Adverse Event Categorized on the Basis of Exposure to Anidulafungin (AUC0-24,ss) | 10 Participants |
| Anidulafungin: Participants Aged 5 to <18 Years | Number of Participants With Greater Than or Equal to 1 Gastro-Intestinal (GI) Adverse Event Categorized on the Basis of Exposure to Anidulafungin (AUC0-24,ss) | 6 Participants |
| AUC0-24ss (>89-109 mcg*hr/ml) | Number of Participants With Greater Than or Equal to 1 Gastro-Intestinal (GI) Adverse Event Categorized on the Basis of Exposure to Anidulafungin (AUC0-24,ss) | 4 Participants |
| AUC0-24ss (>109 mcg*hr/ml) | Number of Participants With Greater Than or Equal to 1 Gastro-Intestinal (GI) Adverse Event Categorized on the Basis of Exposure to Anidulafungin (AUC0-24,ss) | 2 Participants |
Secondary
Number of Participants With Greater Than or Equal to 1 Hepatic Adverse Event Categorized on the Basis of Exposure to Anidulafungin (AUC0-24,ss)
The probability of having at least one hepatic adverse event was compared with AUC0-24,ss quantile. Individual parameter estimates from the final PK model were used for estimation of Anidulafungin exposures.
Time frame: Baseline to End of intravenous treatment (EOIVT) (maximum of 35 days)
Population: Analysis performed on all participants who received at least one dose of the study treatment (Anidulafungin) and had estimable exposure parameters available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years | Number of Participants With Greater Than or Equal to 1 Hepatic Adverse Event Categorized on the Basis of Exposure to Anidulafungin (AUC0-24,ss) | 1 Participants |
| Anidulafungin: Participants Aged 2 to <5 Years | Number of Participants With Greater Than or Equal to 1 Hepatic Adverse Event Categorized on the Basis of Exposure to Anidulafungin (AUC0-24,ss) | 3 Participants |
| Anidulafungin: Participants Aged 5 to <18 Years | Number of Participants With Greater Than or Equal to 1 Hepatic Adverse Event Categorized on the Basis of Exposure to Anidulafungin (AUC0-24,ss) | 5 Participants |
| AUC0-24ss (>89-109 mcg*hr/ml) | Number of Participants With Greater Than or Equal to 1 Hepatic Adverse Event Categorized on the Basis of Exposure to Anidulafungin (AUC0-24,ss) | 1 Participants |
| AUC0-24ss (>109 mcg*hr/ml) | Number of Participants With Greater Than or Equal to 1 Hepatic Adverse Event Categorized on the Basis of Exposure to Anidulafungin (AUC0-24,ss) | 2 Participants |
Secondary
Percentage of Participants With Global Response Categorized on the Basis of Exposure to Anidulafungin (AUC0-24,ss)
The probabilities of a global response of success or failure were compared with AUC0-24,ss quantile. Individual parameter estimates from the final PK model were used for estimation of Anidulafungin exposures. For the analysis of this outcome measure, global response was categorized as: success or failure. Success defined as clinical response (CR) of cure (resolution of signs, symptoms attributed to Candida infection \[CI\]). Failure defined as CR of failure (no significant improvement in signs symptoms/ death due to CI) and/or microbiological failure (persistence/new infection at follow-up/relapse of infection at follow-up).
Time frame: EOIVT (maximum of 35 days) and EOT (maximum of 49 days)
Population: mITT population: participants who had received at least 1 dose of study drug and who had microbiological confirmation of Candida infection. Here Overall number of participants analyzed signifies participants who were evaluable for this outcome measure and 'Number analyzed' = Participants evaluable for this outcome measure at specified categories.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years | Percentage of Participants With Global Response Categorized on the Basis of Exposure to Anidulafungin (AUC0-24,ss) | EOIVT: Success | 100 percentage of participants |
| Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years | Percentage of Participants With Global Response Categorized on the Basis of Exposure to Anidulafungin (AUC0-24,ss) | EOT: Failure | 0 percentage of participants |
| Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years | Percentage of Participants With Global Response Categorized on the Basis of Exposure to Anidulafungin (AUC0-24,ss) | EOT: Success | 100 percentage of participants |
| Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years | Percentage of Participants With Global Response Categorized on the Basis of Exposure to Anidulafungin (AUC0-24,ss) | EOIVT: Failure | 0 percentage of participants |
| Anidulafungin: Participants Aged 2 to <5 Years | Percentage of Participants With Global Response Categorized on the Basis of Exposure to Anidulafungin (AUC0-24,ss) | EOT: Failure | 6.67 percentage of participants |
| Anidulafungin: Participants Aged 2 to <5 Years | Percentage of Participants With Global Response Categorized on the Basis of Exposure to Anidulafungin (AUC0-24,ss) | EOIVT: Failure | 6.67 percentage of participants |
| Anidulafungin: Participants Aged 2 to <5 Years | Percentage of Participants With Global Response Categorized on the Basis of Exposure to Anidulafungin (AUC0-24,ss) | EOIVT: Success | 93.33 percentage of participants |
| Anidulafungin: Participants Aged 2 to <5 Years | Percentage of Participants With Global Response Categorized on the Basis of Exposure to Anidulafungin (AUC0-24,ss) | EOT: Success | 93.33 percentage of participants |
| Anidulafungin: Participants Aged 5 to <18 Years | Percentage of Participants With Global Response Categorized on the Basis of Exposure to Anidulafungin (AUC0-24,ss) | EOT: Success | 77.78 percentage of participants |
| Anidulafungin: Participants Aged 5 to <18 Years | Percentage of Participants With Global Response Categorized on the Basis of Exposure to Anidulafungin (AUC0-24,ss) | EOIVT: Success | 77.78 percentage of participants |
| Anidulafungin: Participants Aged 5 to <18 Years | Percentage of Participants With Global Response Categorized on the Basis of Exposure to Anidulafungin (AUC0-24,ss) | EOT: Failure | 22.22 percentage of participants |
| Anidulafungin: Participants Aged 5 to <18 Years | Percentage of Participants With Global Response Categorized on the Basis of Exposure to Anidulafungin (AUC0-24,ss) | EOIVT: Failure | 22.22 percentage of participants |
| AUC0-24ss (>89-109 mcg*hr/ml) | Percentage of Participants With Global Response Categorized on the Basis of Exposure to Anidulafungin (AUC0-24,ss) | EOT: Success | 87.5 percentage of participants |
| AUC0-24ss (>89-109 mcg*hr/ml) | Percentage of Participants With Global Response Categorized on the Basis of Exposure to Anidulafungin (AUC0-24,ss) | EOIVT: Failure | 12.5 percentage of participants |
| AUC0-24ss (>89-109 mcg*hr/ml) | Percentage of Participants With Global Response Categorized on the Basis of Exposure to Anidulafungin (AUC0-24,ss) | EOIVT: Success | 87.5 percentage of participants |
| AUC0-24ss (>89-109 mcg*hr/ml) | Percentage of Participants With Global Response Categorized on the Basis of Exposure to Anidulafungin (AUC0-24,ss) | EOT: Failure | 12.5 percentage of participants |
| AUC0-24ss (>109 mcg*hr/ml) | Percentage of Participants With Global Response Categorized on the Basis of Exposure to Anidulafungin (AUC0-24,ss) | EOT: Failure | 12.5 percentage of participants |
| AUC0-24ss (>109 mcg*hr/ml) | Percentage of Participants With Global Response Categorized on the Basis of Exposure to Anidulafungin (AUC0-24,ss) | EOIVT: Success | 85.71 percentage of participants |
| AUC0-24ss (>109 mcg*hr/ml) | Percentage of Participants With Global Response Categorized on the Basis of Exposure to Anidulafungin (AUC0-24,ss) | EOIVT: Failure | 14.29 percentage of participants |
| AUC0-24ss (>109 mcg*hr/ml) | Percentage of Participants With Global Response Categorized on the Basis of Exposure to Anidulafungin (AUC0-24,ss) | EOT: Success | 87.5 percentage of participants |
Secondary
Percentage of Participants With New Infection
New infection was defined as a participant presenting with clinical failure with the emergence of new Candida species at the original site of infection or at a distant site of infection. Clinical response of failure was defined as no significant improvement in signs and symptoms, or death due to the Candida infection occurred. Participants had received at least 3 doses of study medication to be classified as a failure. End of treatment visit defined as last day of study treatment (IV or oral).
Time frame: During 2 week follow-up (up to 63 days) and 6 week follow-up (up to 91 days) after EOT
Population: The mITT population was defined as all participants who had received at least 1 dose of study drug and who had microbiological confirmation of Candida infection.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years | Percentage of Participants With New Infection | 2 week follow-up | 0.0 percentage of participants |
| Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years | Percentage of Participants With New Infection | 6 week follow-up | 0.0 percentage of participants |
| Anidulafungin: Participants Aged 2 to <5 Years | Percentage of Participants With New Infection | 2 week follow-up | 0.0 percentage of participants |
| Anidulafungin: Participants Aged 2 to <5 Years | Percentage of Participants With New Infection | 6 week follow-up | 0.0 percentage of participants |
| Anidulafungin: Participants Aged 5 to <18 Years | Percentage of Participants With New Infection | 2 week follow-up | 0.0 percentage of participants |
| Anidulafungin: Participants Aged 5 to <18 Years | Percentage of Participants With New Infection | 6 week follow-up | 0.0 percentage of participants |
Secondary
Percentage of Participants With Relapsed Response
Relapse was defined as any baseline Candida species isolated following eradication (documented or presumed); or culture data not available for a participant with a clinical response of failure after a previous response of success. Clinical response of failure was defined as no significant improvement in signs and symptoms, or death due to the Candida infection. Participants had received at least 3 doses of study medication to be classified as a failure. Clinical response of success was defined as resolution of sign and symptoms attributed to Candida infection occurred with no additional systemic or oral antifungal treatment required to complete the course of therapy. Eradication or presumed eradication: baseline pathogen not isolated from original site culture(s), or culture data are not available for a participant with successful clinical outcome. End of treatment visit defined as last day of study treatment (IV or oral).
Time frame: During 2 week follow-up after EOT (up to 63 days) and during 6 week follow-up after EOT (up to 91 days)
Population: The mITT population was defined as all participants who had received at least 1 dose of study drug and who had microbiological confirmation of Candida infection.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years | Percentage of Participants With Relapsed Response | 2 week follow-up | 0.0 percentage of participants |
| Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years | Percentage of Participants With Relapsed Response | 6 week follow-up | 0.0 percentage of participants |
| Anidulafungin: Participants Aged 2 to <5 Years | Percentage of Participants With Relapsed Response | 2 week follow-up | 0.0 percentage of participants |
| Anidulafungin: Participants Aged 2 to <5 Years | Percentage of Participants With Relapsed Response | 6 week follow-up | 5.6 percentage of participants |
| Anidulafungin: Participants Aged 5 to <18 Years | Percentage of Participants With Relapsed Response | 2 week follow-up | 0.0 percentage of participants |
| Anidulafungin: Participants Aged 5 to <18 Years | Percentage of Participants With Relapsed Response | 6 week follow-up | 6.7 percentage of participants |