Ascariasis, Helminthes; Infestation, Intestinal, Hookworm Infections, Trichuriasis
Conditions
Keywords
T. trichiura, A. lumbricoides, Hookworm, Soil-transmitted Helminths, Albendazole, Ivermectin, Moxidectin, Intestinal parasites, Anthelmintics
Brief summary
The aim of this randomized controlled trial is to provide evidence on the efficacy and safety of co-administered moxidectin and albendazole compared to co-administered ivermectin and albendazole, and to assess the efficacy of the drug combinations compared to monotherapies in adolescents aged 12-19 years against infection with T. trichiura. The efficacy of the different treatments will be determined 14-21 days, 5-6 weeks and 3 months post-treatment. Two fecal samples will be collected at each time-point assessment. The geometric mean based egg reduction rate (ERR) of T. trichiura egg counts will be assessed by Kato-Katz microscopy pre-treatment and 14-21 days post-treatment. This trial will be conducted as a school-based study on Pemba Island (Zanzibar, Tanzania).
Detailed description
We designed a non-inferiority trial to show that co-administered moxidectin and albendazole is non-inferior compared to co-administered ivermectin and albendazole in adolescents aged 12-19 years on Pemba Island (Tanzania). From previous studies conducted by our group, we expect similar efficacies from the combination moxidectin/ albendazole compared to ivermectin/ albendazole. However, moxidectin might be advantageous in terms of the drug's longer half-life and in areas with possible emerging ivermectin resistance. This study will allow comparing the efficacy of the two available co-administrations and will provide further insights on the potential value of moxidectin/ albendazole. Our data will pave the way for possible large scale, multi country follow-up studies. As recommended for new combination therapies, we simultaneously assess superiority of the drug combinations compared to monotherapies. The primary objective is to demonstrate that co-administered moxidectin (8 mg) / albendazole (400 mg) is non-inferior to ivermectin (200 µg/kg) / albendazole (400 mg) in terms of egg reduction rates (ERRs) against T. trichiura infections assessed by Kato-Katz at 14-21 days post-treatment in adolescents aged 12-19 years using a non-inferiority margin of 2 percentage-points. The secondary objectives of the trial are: 1. Efficacy assessments of combination therapies require demonstration of superiority against the respective monotherapies. Therefore, the trial has five different treatment groups: moxidectin (8 mg) / albendazole (400 mg) combination, ivermectin (200 µg/kg) / albendazole (400 mg) combination, albendazole (400 mg) monotherapy, ivermectin (200 µg/kg) monotherapy and moxidectin (8 mg) monotherapy. 2. to determine the CRs of the drug regimens against T. trichiura 3. to evaluate the safety and tolerability of the treatment 4. to determine the CRs and ERRs of the treatment schemes in study participants infected with hookworm and A. lumbricoides 5. to investigate potential extended effects on follow-up helminth prevalences (5-6 weeks and 3 months post-treatment) of the treatment regimens 6. to assess diagnostic performance and compare CRs based on egg counts retrieved from novel diagnostic tools (FECPAK-G2 and/or PCR) compared to standard microscopy 7. to characterize population PK parameters, as well as drug-drug interactions of active study treatments following single and co-administration in T. trichiura infected adolescents. If a dose-response is observed, a PK/PD analysis will further be performed The study will be carried out in adolescents aged 12-19 years attending secondary schools on Pemba Island, Tanzania. After consenting, all participants will be asked to provide two stool samples (within a maximum of 7 days) at each time-point assesment. From each stool specimen, duplicate Kato-Katz thick smears (41.7 mg each) will be prepared and read under a microscope for eggs of T. trichiura, A. lumbricoides and hookworm by experienced technicians. After randomization, all eligible adolescents will be treated with the respective single or combination treatment regimen according to their assigned treatment arm at day 0. All drugs will be administered in the presence of the PI and/ co-PI, and ingestion confirmed. This will be recorded with the time and date of dosing. Participants will be kept for 3 hours after treatment administration to observe any possible acute AEs and reassessment will be done at 24h post-treatment. Additionally, interviews will be conducted to determine the emergence of clinical symptoms such as headache, abdominal pain, itching, nausea, vomiting and diarrhea directly before treatment within the scope of baseline assessment. At 3 and 24 hours after treatment and retrospectively at days 14 - 21 as well as 5-6 weeks and 3 months post-treatment, participants will again be interviewed for the assessment of adverse events (AEs). Egg reduction rate calculated from the geometric means of co-administered moxidectin/ albendazole and ivermectin/ albendazole against T. trichiura assessed at 14-21 days post-treatment is the primary endpoint in our study.
Interventions
DRUGmoxidectin (8 mg) / albendazole (400 mg)
Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
DRUGivermectin (200 µg/kg) / albendazole (400 mg)
Combination therapy of ivermectin ((200 µg/kg), 3 mg tablet) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
DRUGALBENDAZOLE 400 Mg ORAL TABLET [ZENTEL]
Monotherapy of albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
DRUGivermectin (200 µg/kg)
Monotherapy of ivermectin ((200 µg/kg), 3 mg tablet) administered orally at day 0
DRUGmoxidectin (8 mg)
Monotherapy of moxidectin (8 mg, using 2 mg tablets) administered orally at day 0
Sponsors
Public Health Laboratory Ivo de Carneri
Jennifer Keiser
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Open Label with masked outcomes assessors
Eligibility
Sex/Gender
ALL
Age
12 Years to 19 Years
Healthy volunteers
No
Inclusion criteria
* Aged between 12 and 19 years. * Written informed consent signed by either parents/caregivers for underage adolescents (aged 12-17 years) or by the participant him/herself (18-19 years of age); and written assent by underage participant. * Agree to comply with study procedures, including provision of two stool samples at the beginning (baseline) and on three follow-up assessments (14-21 days, 5-6 weeks and 3 months after treatment). * Willing to be examined by a study physician prior to treatment. * At least two slides of the quadruple Kato-Katz thick smears positive for T. trichiura and infection intensities of at least 48 EPG.
Exclusion criteria
* No written informed consent by individual or caregiver and/or no written assent by minors * Presence or signs of major systemic illnesses, e.g. body temperature ≥ 38°C, severe anemia (below 80g/l Hb according to WHO) upon initial clinical assessment. * History of acute or severe chronic disease. * Recent use of anthelmintic drug (within past 4 weeks). * Attending other clinical trials during the study. * Pregnancy, lactating, and/or planning to become pregnant within the next 6 months. * Known allergy to study medications (i.e. albendazole, ivermectin or moxidectin). * Taking medication with known interaction on study drugs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Egg Reduction Rate Against T. Trichiura | 14-21 day post-treatment | Egg reduction rate is calculated as the relative reduction in the group geometric mean egg output after co-administration of moxidectin/ albendazole and ivermectin/ albendazole assessed at 14-21 days post-treatment compared to the baseline levels. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Superiority in Terms of Cure Rates (CRs) | 14-21 day post-treatment | Assessment of superiority in terms of CRs of the drug combinations compared to their corresponding monotherapies: Arm C: Albendazole (400 mg) Arm D: Ivermectin (200 μg/kg) and Arm E: Moxidectin (8 mg). Cure rates is defined as the percentages of participants treated with Moxidectin (8 mg)/Albendazole (400 mg), Ivermectin (200 μg/kg)/Albendazole (400 mg), Albendazole (400 mg), Ivermectin (200 μg/kg) or Moxidectin (8 mg) who were cured of infections with T. trichiura. |
| Cure Rates Against T. Trichiura | 14-21 day post-treatment | Cure rates of each treatment will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment. |
| Extended Effects (Egg Reduction Rate) on Follow-up of T. Trichiura: 5-6 Weeks | 5-6 weeks post-treatment | Eggs per gram of stool will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs. |
| Extended Effects (Cure Rate) on Follow-up of T. Trichiura: 5-6 Weeks | 5-6 weeks post-treatment | Cure rates of each treatment will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment. |
| Extended Effects (Egg Reduction Rate) on Follow-up of T. Trichiura: 3 Months | 3 months post-treatment | Eggs per gram of stool will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs. |
| Extended Effects (Cure Rates) on Follow-up of T. Trichiura: 3 Months | 3 months post-treatment | Cure rates of each treatment will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment. |
| Egg Reduction Rates Against Concomitant Soil-transmitted Helminth Infections: Hookworm | 14-21 days post-treatment | Eggs per gram of stool will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs. |
| Cure Rates Against Concomitant Soil-transmitted Helminth Infections: Hookworm | 14-21 days post-treatment | Cure rates of each treatment will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment. |
| Extended Effects (Egg Reduction Rate) on Follow-up of Hookworm: 5-6 Weeks | 5-6 weeks post-treatment | Eggs per gram of stool will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs. |
| Number of Participants With Adverse Events | 3 hours, 24 hours, 14-21 days, 5-6 weeks and 3 months post-treatment | The observation time for AE starts when the treatment is initiated. Subjects will be kept for observation for at least 3 hours following treatment for any acute AE and. If there is any abnormal finding, the local study physician will perform a full clinical examination and findings will be recorded. An emergency kit will be available on site to treat any medical conditions that warrant urgent medical intervention. Participants will also be interviewed at 3h and 24h as well as retrospectively 14 -21 days, 5-6 weeks and 3 months after treatment about the occurrence of AEs. |
| Extended Effects (Egg Reduction Rate) on Follow-up of Hookworm: 3 Months | 3 months post-treatment | Eggs per gram of stool will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs. |
| Extended Effects (Cure Rate) on Follow-up of Hookworm: 3 Months | 3 months post-treatment | Cure rates of each treatment will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment. |
| Egg Reduction Rates Against Concomitant Soil-transmitted Helminth Infections: Ascaris Lumbricoides | 14-21 days post-treatment | Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs. |
| Cure Rates Against Concomitant Soil-transmitted Helminth Infections: Ascaris Lumbricoides | 14-21 days post-treatment | Cure rates is defined as the percentages of participants treated with Moxidectin (8 mg)/Albendazole (400 mg), Ivermectin (200 μg/kg)/Albendazole (400 mg), Albendazole (400 mg), Ivermectin (200 μg/kg) or Moxidectin (8 mg) who were cured of infections with A. lumbricoides. |
| Extended Effects (Egg Reduction Rate) on Follow-up of A. Lumbricoides: 5-6 Weeks | 5-6 weeks post-treatment | Eggs per gram of stool will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs. |
| Extended Effects (Cure Rate) on Follow-up of A. Lumbricoides: 5-6 Weeks | 5-6 weeks post-treatment | Cure rates of each treatment will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment. |
| Extended Effects (Egg Reduction Rate) on Follow-up of A. Lumbricoides: 3 Months | 3 months post-treatment | Eggs per gram of stool will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs. |
| Extended Effects (Cure Rate) on Follow-up of A. Lumbricoides: 3 Months | 3 months post-treatment | Cure rates of each treatment will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment. |
| Extended Effects (Cure Rate) on Follow-up of Hookworm: 5-6 Weeks | 5-6 weeks post-treatment | Cure rates of each treatment will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment. |
Countries
Tanzania
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| A: Moxidectin (8 mg) / Albendazole (400 mg) Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
moxidectin (8 mg) / albendazole (400 mg): Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0 | 207 |
| B: Ivermectin (200 µg/kg) / Albendazole (400 mg) Combination therapy of ivermectin (Stromectol®, 200 µg/kg using 3 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
ivermectin (200 µg/kg) / albendazole (400 mg): Combination therapy of ivermectin ((200 µg/kg), 3 mg tablet) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0 | 211 |
| C: Albendazole (400 mg) Monotherapy of albendazole (400 mg) administered orally at day 0 Other names: Zentel®
ALBENDAZOLE 400 Mg ORAL TABLET \[ZENTEL\]: Monotherapy of albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0 | 19 |
| D: Ivermectin (200 µg/kg) Monotherapy of ivermectin ( 200 µg/kg using 3 mg tablets) administered orally at day 0 Other names: Stromectol®
ivermectin (200 µg/kg): Monotherapy of ivermectin ((200 µg/kg), 3 mg tablet) administered orally at day 0 | 19 |
| E: Moxidectin (8 mg) Monotherapy of moxidectin (8 mg using 2 mg tablets) administered orally at day 0
moxidectin (8 mg): Monotherapy of moxidectin (8 mg, using 2 mg tablets) administered orally at day 0 | 80 |
| Total | 536 |
Baseline characteristics
| Characteristic | B: Ivermectin (200 µg/kg) / Albendazole (400 mg) | C: Albendazole (400 mg) | D: Ivermectin (200 µg/kg) | A: Moxidectin (8 mg) / Albendazole (400 mg) | E: Moxidectin (8 mg) | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 15.8 years STANDARD_DEVIATION 1.5 | 15.6 years STANDARD_DEVIATION 1.2 | 15.9 years STANDARD_DEVIATION 1.3 | 15.8 years STANDARD_DEVIATION 1.5 | 15.8 years STANDARD_DEVIATION 1.4 | 15.8 years STANDARD_DEVIATION 1.5 |
| A. lumbricoides infection, arithmetic mean EPG | 14284 eggs per gram STANDARD_DEVIATION 20566 | 17062 eggs per gram STANDARD_DEVIATION 19533 | 9821 eggs per gram STANDARD_DEVIATION 9162 | 15823 eggs per gram STANDARD_DEVIATION 18844 | 11969 eggs per gram STANDARD_DEVIATION 12883 | 14247 eggs per gram STANDARD_DEVIATION 18323 |
| A. lumbricoides infection, geometric mean EPG | 5934 eggs per gram STANDARD_DEVIATION 5 | 8512 eggs per gram STANDARD_DEVIATION 4 | 4724 eggs per gram STANDARD_DEVIATION 4 | 7819 eggs per gram STANDARD_DEVIATION 4 | 6765 eggs per gram STANDARD_DEVIATION 4 | 6728 eggs per gram STANDARD_DEVIATION 4 |
| A. lumbricoides infection intensity (EPG): heavy | 6 Participants | 1 Participants | 0 Participants | 6 Participants | 1 Participants | 14 Participants |
| A. lumbricoides infection intensity (EPG): moderate | 55 Participants | 7 Participants | 7 Participants | 61 Participants | 32 Participants | 162 Participants |
| A. lumbricoides infection, No. infected | 110 Participants | 12 Participants | 14 Participants | 106 Participants | 50 Participants | 292 Participants |
| A. lumbricoides intensity (EPG): light | 49 Participants | 4 Participants | 7 Participants | 39 Participants | 17 Participants | 116 Participants |
| Height, cm | 157.2 cm STANDARD_DEVIATION 7.3 | 159.1 cm STANDARD_DEVIATION 7.8 | 158.9 cm STANDARD_DEVIATION 7.1 | 157.1 cm STANDARD_DEVIATION 7.4 | 157.4 cm STANDARD_DEVIATION 6.8 | 157.3 cm STANDARD_DEVIATION 7.3 |
| Hookworm infection, arithmetic mean EPG | 261 eggs per gram STANDARD_DEVIATION 385 | 428 eggs per gram STANDARD_DEVIATION 644 | 200 eggs per gram STANDARD_DEVIATION 208 | 261 eggs per gram STANDARD_DEVIATION 332 | 150 eggs per gram STANDARD_DEVIATION 175 | 243 eggs per gram STANDARD_DEVIATION 337 |
| Hookworm infection, geometric mean EPG | 112 eggs per gram STANDARD_DEVIATION 4 | 128 eggs per gram STANDARD_DEVIATION 8 | 94 eggs per gram STANDARD_DEVIATION 5 | 125 eggs per gram STANDARD_DEVIATION 4 | 89 eggs per gram STANDARD_DEVIATION 3 | 111 eggs per gram STANDARD_DEVIATION 4 |
| Hookworm infection intensity (EPG): light | 70 Participants | 3 Participants | 8 Participants | 64 Participants | 28 Participants | 173 Participants |
| Hookworm infection, No. infected | 70 Participants | 3 Participants | 8 Participants | 64 Participants | 28 Participants | 173 Participants |
| Race and Ethnicity Not Collected | — | — | — | — | — | 0 Participants |
| Sex: Female, Male Female | 163 Participants | 13 Participants | 16 Participants | 148 Participants | 54 Participants | 394 Participants |
| Sex: Female, Male Male | 48 Participants | 6 Participants | 3 Participants | 59 Participants | 26 Participants | 142 Participants |
| T. trichiura infection, arithmetic mean EPG | 1045 eggs per gram STANDARD_DEVIATION 1509 | 1014 eggs per gram STANDARD_DEVIATION 1504 | 1670 eggs per gram STANDARD_DEVIATION 3243 | 975 eggs per gram STANDARD_DEVIATION 1329 | 935 eggs per gram STANDARD_DEVIATION 1435 | 1022 eggs per gram STANDARD_DEVIATION 1525 |
| T. trichiura infection, geometric mean EPG | 468 eggs per gram STANDARD_DEVIATION 4 | 421 eggs per gram STANDARD_DEVIATION 4 | 573 eggs per gram STANDARD_DEVIATION 4 | 450 eggs per gram STANDARD_DEVIATION 4 | 481 eggs per gram STANDARD_DEVIATION 3 | 463 eggs per gram STANDARD_DEVIATION 4 |
| T. trichiura infection intensity (EPG): heavy | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| T. trichiura infection intensity (EPG): light | 148 Participants | 14 Participants | 14 Participants | 144 Participants | 57 Participants | 377 Participants |
| T. trichiura infection intensity (EPG): moderate | 63 Participants | 5 Participants | 4 Participants | 63 Participants | 23 Participants | 158 Participants |
| Weight, kg | 47.7 kg STANDARD_DEVIATION 8.2 | 50.8 kg STANDARD_DEVIATION 7.8 | 48.1 kg STANDARD_DEVIATION 6.1 | 48.3 kg STANDARD_DEVIATION 8.3 | 47.1 kg STANDARD_DEVIATION 6.5 | 48.0 kg STANDARD_DEVIATION 7.9 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 207 | 0 / 211 | 0 / 19 | 0 / 19 | 0 / 80 |
| other Total, other adverse events | 73 / 207 | 93 / 211 | 4 / 19 | 6 / 19 | 23 / 80 |
| serious Total, serious adverse events | 0 / 207 | 0 / 211 | 0 / 19 | 0 / 19 | 0 / 80 |
Outcome results
Primary
Egg Reduction Rate Against T. Trichiura
Egg reduction rate is calculated as the relative reduction in the group geometric mean egg output after co-administration of moxidectin/ albendazole and ivermectin/ albendazole assessed at 14-21 days post-treatment compared to the baseline levels.
Time frame: 14-21 day post-treatment
Population: Geometric mean reduction in number of eggs at baseline and assessed at 14-21 days post-treatment
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| A: Moxidectin (8 mg) / Albendazole (400 mg) | Egg Reduction Rate Against T. Trichiura | 96.8 Percent change |
| B: Ivermectin (200 µg/kg) / Albendazole (400 mg) | Egg Reduction Rate Against T. Trichiura | 99.0 Percent change |
| C: Albendazole (400 mg) | Egg Reduction Rate Against T. Trichiura | 86.2 Percent change |
| D: Ivermectin (200 µg/kg) | Egg Reduction Rate Against T. Trichiura | 94.2 Percent change |
| E: Moxidectin (8 mg) | Egg Reduction Rate Against T. Trichiura | 85.5 Percent change |
Secondary
Cure Rates Against Concomitant Soil-transmitted Helminth Infections: Ascaris Lumbricoides
Cure rates is defined as the percentages of participants treated with Moxidectin (8 mg)/Albendazole (400 mg), Ivermectin (200 μg/kg)/Albendazole (400 mg), Albendazole (400 mg), Ivermectin (200 μg/kg) or Moxidectin (8 mg) who were cured of infections with A. lumbricoides.
Time frame: 14-21 days post-treatment
Population: Number of participants found positive for A. lumbricoides at baseline and assessed at 14-21 days post-treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| A: Moxidectin (8 mg) / Albendazole (400 mg) | Cure Rates Against Concomitant Soil-transmitted Helminth Infections: Ascaris Lumbricoides | 100.0 Percentage of participants |
| B: Ivermectin (200 µg/kg) / Albendazole (400 mg) | Cure Rates Against Concomitant Soil-transmitted Helminth Infections: Ascaris Lumbricoides | 96.4 Percentage of participants |
| C: Albendazole (400 mg) | Cure Rates Against Concomitant Soil-transmitted Helminth Infections: Ascaris Lumbricoides | 91.7 Percentage of participants |
| D: Ivermectin (200 µg/kg) | Cure Rates Against Concomitant Soil-transmitted Helminth Infections: Ascaris Lumbricoides | 100.0 Percentage of participants |
| E: Moxidectin (8 mg) | Cure Rates Against Concomitant Soil-transmitted Helminth Infections: Ascaris Lumbricoides | 98.0 Percentage of participants |
Secondary
Cure Rates Against Concomitant Soil-transmitted Helminth Infections: Hookworm
Cure rates of each treatment will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment.
Time frame: 14-21 days post-treatment
Population: Number of participants found positive for hookworm at baseline and assessed at 14-21 days post-treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| A: Moxidectin (8 mg) / Albendazole (400 mg) | Cure Rates Against Concomitant Soil-transmitted Helminth Infections: Hookworm | 75.0 Percentage of participants |
| B: Ivermectin (200 µg/kg) / Albendazole (400 mg) | Cure Rates Against Concomitant Soil-transmitted Helminth Infections: Hookworm | 62.9 Percentage of participants |
| C: Albendazole (400 mg) | Cure Rates Against Concomitant Soil-transmitted Helminth Infections: Hookworm | 100.0 Percentage of participants |
| D: Ivermectin (200 µg/kg) | Cure Rates Against Concomitant Soil-transmitted Helminth Infections: Hookworm | 25.0 Percentage of participants |
| E: Moxidectin (8 mg) | Cure Rates Against Concomitant Soil-transmitted Helminth Infections: Hookworm | 32.1 Percentage of participants |
Secondary
Cure Rates Against T. Trichiura
Cure rates of each treatment will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment.
Time frame: 14-21 day post-treatment
Population: Number of participants found positive for hookworm at 14-21 days post-treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| A: Moxidectin (8 mg) / Albendazole (400 mg) | Cure Rates Against T. Trichiura | 34.3 Percentage of participants |
| B: Ivermectin (200 µg/kg) / Albendazole (400 mg) | Cure Rates Against T. Trichiura | 54.0 Percentage of participants |
| C: Albendazole (400 mg) | Cure Rates Against T. Trichiura | 26.3 Percentage of participants |
| D: Ivermectin (200 µg/kg) | Cure Rates Against T. Trichiura | 10.5 Percentage of participants |
| E: Moxidectin (8 mg) | Cure Rates Against T. Trichiura | 11.2 Percentage of participants |
Secondary
Egg Reduction Rates Against Concomitant Soil-transmitted Helminth Infections: Ascaris Lumbricoides
Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs.
Time frame: 14-21 days post-treatment
Population: Geometric mean reduction in number of eggs at baseline and assessed at 14-21 days post-treatment
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| A: Moxidectin (8 mg) / Albendazole (400 mg) | Egg Reduction Rates Against Concomitant Soil-transmitted Helminth Infections: Ascaris Lumbricoides | 100.0 Percent change |
| B: Ivermectin (200 µg/kg) / Albendazole (400 mg) | Egg Reduction Rates Against Concomitant Soil-transmitted Helminth Infections: Ascaris Lumbricoides | 100.0 Percent change |
| C: Albendazole (400 mg) | Egg Reduction Rates Against Concomitant Soil-transmitted Helminth Infections: Ascaris Lumbricoides | 100.0 Percent change |
| D: Ivermectin (200 µg/kg) | Egg Reduction Rates Against Concomitant Soil-transmitted Helminth Infections: Ascaris Lumbricoides | 100.0 Percent change |
| E: Moxidectin (8 mg) | Egg Reduction Rates Against Concomitant Soil-transmitted Helminth Infections: Ascaris Lumbricoides | 100.0 Percent change |
Secondary
Egg Reduction Rates Against Concomitant Soil-transmitted Helminth Infections: Hookworm
Eggs per gram of stool will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs.
Time frame: 14-21 days post-treatment
Population: Geometric mean reduction in number of eggs at baseline and assessed at 14-21 days post-treatment
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| A: Moxidectin (8 mg) / Albendazole (400 mg) | Egg Reduction Rates Against Concomitant Soil-transmitted Helminth Infections: Hookworm | 98.8 Percent change |
| B: Ivermectin (200 µg/kg) / Albendazole (400 mg) | Egg Reduction Rates Against Concomitant Soil-transmitted Helminth Infections: Hookworm | 97.4 Percent change |
| C: Albendazole (400 mg) | Egg Reduction Rates Against Concomitant Soil-transmitted Helminth Infections: Hookworm | 100.0 Percent change |
| D: Ivermectin (200 µg/kg) | Egg Reduction Rates Against Concomitant Soil-transmitted Helminth Infections: Hookworm | 61.9 Percent change |
| E: Moxidectin (8 mg) | Egg Reduction Rates Against Concomitant Soil-transmitted Helminth Infections: Hookworm | 81.2 Percent change |
Secondary
Extended Effects (Cure Rate) on Follow-up of A. Lumbricoides: 3 Months
Cure rates of each treatment will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment.
Time frame: 3 months post-treatment
Population: Number of participants found positive for hookworm at 3 months post-treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| A: Moxidectin (8 mg) / Albendazole (400 mg) | Extended Effects (Cure Rate) on Follow-up of A. Lumbricoides: 3 Months | 87.3 Percentage of participants |
| B: Ivermectin (200 µg/kg) / Albendazole (400 mg) | Extended Effects (Cure Rate) on Follow-up of A. Lumbricoides: 3 Months | 88.2 Percentage of participants |
| C: Albendazole (400 mg) | Extended Effects (Cure Rate) on Follow-up of A. Lumbricoides: 3 Months | 91.7 Percentage of participants |
| D: Ivermectin (200 µg/kg) | Extended Effects (Cure Rate) on Follow-up of A. Lumbricoides: 3 Months | 92.9 Percentage of participants |
| E: Moxidectin (8 mg) | Extended Effects (Cure Rate) on Follow-up of A. Lumbricoides: 3 Months | 87.5 Percentage of participants |
Secondary
Extended Effects (Cure Rate) on Follow-up of A. Lumbricoides: 5-6 Weeks
Cure rates of each treatment will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment.
Time frame: 5-6 weeks post-treatment
Population: Number of participants found positive for hookworm at 5-6 weeks post-treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| A: Moxidectin (8 mg) / Albendazole (400 mg) | Extended Effects (Cure Rate) on Follow-up of A. Lumbricoides: 5-6 Weeks | 100.0 Percentage of participants |
| B: Ivermectin (200 µg/kg) / Albendazole (400 mg) | Extended Effects (Cure Rate) on Follow-up of A. Lumbricoides: 5-6 Weeks | 100.0 Percentage of participants |
| C: Albendazole (400 mg) | Extended Effects (Cure Rate) on Follow-up of A. Lumbricoides: 5-6 Weeks | 100.0 Percentage of participants |
| D: Ivermectin (200 µg/kg) | Extended Effects (Cure Rate) on Follow-up of A. Lumbricoides: 5-6 Weeks | 100.0 Percentage of participants |
| E: Moxidectin (8 mg) | Extended Effects (Cure Rate) on Follow-up of A. Lumbricoides: 5-6 Weeks | 98.0 Percentage of participants |
Secondary
Extended Effects (Cure Rate) on Follow-up of Hookworm: 3 Months
Cure rates of each treatment will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment.
Time frame: 3 months post-treatment
Population: Number of participants found positive for hookworm at 3 months post-treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| A: Moxidectin (8 mg) / Albendazole (400 mg) | Extended Effects (Cure Rate) on Follow-up of Hookworm: 3 Months | 66.1 Percentage of participants |
| B: Ivermectin (200 µg/kg) / Albendazole (400 mg) | Extended Effects (Cure Rate) on Follow-up of Hookworm: 3 Months | 60.0 Percentage of participants |
| C: Albendazole (400 mg) | Extended Effects (Cure Rate) on Follow-up of Hookworm: 3 Months | 66.7 Percentage of participants |
| D: Ivermectin (200 µg/kg) | Extended Effects (Cure Rate) on Follow-up of Hookworm: 3 Months | 25.0 Percentage of participants |
| E: Moxidectin (8 mg) | Extended Effects (Cure Rate) on Follow-up of Hookworm: 3 Months | 32.0 Percentage of participants |
Secondary
Extended Effects (Cure Rate) on Follow-up of Hookworm: 5-6 Weeks
Cure rates of each treatment will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment.
Time frame: 5-6 weeks post-treatment
Population: Number of participants found positive for hookworm at 5-6 weeks post-treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| A: Moxidectin (8 mg) / Albendazole (400 mg) | Extended Effects (Cure Rate) on Follow-up of Hookworm: 5-6 Weeks | 71.9 Percentage of participants |
| B: Ivermectin (200 µg/kg) / Albendazole (400 mg) | Extended Effects (Cure Rate) on Follow-up of Hookworm: 5-6 Weeks | 61.4 Percentage of participants |
| C: Albendazole (400 mg) | Extended Effects (Cure Rate) on Follow-up of Hookworm: 5-6 Weeks | 66.7 Percentage of participants |
| D: Ivermectin (200 µg/kg) | Extended Effects (Cure Rate) on Follow-up of Hookworm: 5-6 Weeks | 25.0 Percentage of participants |
| E: Moxidectin (8 mg) | Extended Effects (Cure Rate) on Follow-up of Hookworm: 5-6 Weeks | 42.9 Percentage of participants |
Secondary
Extended Effects (Cure Rate) on Follow-up of T. Trichiura: 5-6 Weeks
Cure rates of each treatment will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment.
Time frame: 5-6 weeks post-treatment
Population: Number of participants found positive for hookworm at 5-6 weeks post-treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| A: Moxidectin (8 mg) / Albendazole (400 mg) | Extended Effects (Cure Rate) on Follow-up of T. Trichiura: 5-6 Weeks | 37.4 Percentage of participants |
| B: Ivermectin (200 µg/kg) / Albendazole (400 mg) | Extended Effects (Cure Rate) on Follow-up of T. Trichiura: 5-6 Weeks | 46.4 Percentage of participants |
| C: Albendazole (400 mg) | Extended Effects (Cure Rate) on Follow-up of T. Trichiura: 5-6 Weeks | 16.7 Percentage of participants |
| D: Ivermectin (200 µg/kg) | Extended Effects (Cure Rate) on Follow-up of T. Trichiura: 5-6 Weeks | 0.0 Percentage of participants |
| E: Moxidectin (8 mg) | Extended Effects (Cure Rate) on Follow-up of T. Trichiura: 5-6 Weeks | 11.2 Percentage of participants |
Secondary
Extended Effects (Cure Rates) on Follow-up of T. Trichiura: 3 Months
Cure rates of each treatment will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment.
Time frame: 3 months post-treatment
Population: Number of participants found positive for T. trichiura at baseline and assessed at 3 months post-treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| A: Moxidectin (8 mg) / Albendazole (400 mg) | Extended Effects (Cure Rates) on Follow-up of T. Trichiura: 3 Months | 27.4 Percentage of participants |
| B: Ivermectin (200 µg/kg) / Albendazole (400 mg) | Extended Effects (Cure Rates) on Follow-up of T. Trichiura: 3 Months | 39.5 Percentage of participants |
| C: Albendazole (400 mg) | Extended Effects (Cure Rates) on Follow-up of T. Trichiura: 3 Months | 11.1 Percentage of participants |
| D: Ivermectin (200 µg/kg) | Extended Effects (Cure Rates) on Follow-up of T. Trichiura: 3 Months | 0.0 Percentage of participants |
| E: Moxidectin (8 mg) | Extended Effects (Cure Rates) on Follow-up of T. Trichiura: 3 Months | 9.1 Percentage of participants |
Secondary
Extended Effects (Egg Reduction Rate) on Follow-up of A. Lumbricoides: 3 Months
Eggs per gram of stool will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs.
Time frame: 3 months post-treatment
Population: Geometric mean reduction in number of eggs at baseline and assessed at 3 months post-treatment
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| A: Moxidectin (8 mg) / Albendazole (400 mg) | Extended Effects (Egg Reduction Rate) on Follow-up of A. Lumbricoides: 3 Months | 100.0 Percent change |
| B: Ivermectin (200 µg/kg) / Albendazole (400 mg) | Extended Effects (Egg Reduction Rate) on Follow-up of A. Lumbricoides: 3 Months | 100.0 Percent change |
| C: Albendazole (400 mg) | Extended Effects (Egg Reduction Rate) on Follow-up of A. Lumbricoides: 3 Months | 100.0 Percent change |
| D: Ivermectin (200 µg/kg) | Extended Effects (Egg Reduction Rate) on Follow-up of A. Lumbricoides: 3 Months | 100.0 Percent change |
| E: Moxidectin (8 mg) | Extended Effects (Egg Reduction Rate) on Follow-up of A. Lumbricoides: 3 Months | 100.0 Percent change |
Secondary
Extended Effects (Egg Reduction Rate) on Follow-up of A. Lumbricoides: 5-6 Weeks
Eggs per gram of stool will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs.
Time frame: 5-6 weeks post-treatment
Population: Geometric mean reduction in number of eggs at baseline and assessed at 5-6 weeks post-treatment
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| A: Moxidectin (8 mg) / Albendazole (400 mg) | Extended Effects (Egg Reduction Rate) on Follow-up of A. Lumbricoides: 5-6 Weeks | 100.0 Percent change |
| B: Ivermectin (200 µg/kg) / Albendazole (400 mg) | Extended Effects (Egg Reduction Rate) on Follow-up of A. Lumbricoides: 5-6 Weeks | 100.0 Percent change |
| C: Albendazole (400 mg) | Extended Effects (Egg Reduction Rate) on Follow-up of A. Lumbricoides: 5-6 Weeks | 100.0 Percent change |
| D: Ivermectin (200 µg/kg) | Extended Effects (Egg Reduction Rate) on Follow-up of A. Lumbricoides: 5-6 Weeks | 100.0 Percent change |
| E: Moxidectin (8 mg) | Extended Effects (Egg Reduction Rate) on Follow-up of A. Lumbricoides: 5-6 Weeks | 100.0 Percent change |
Secondary
Extended Effects (Egg Reduction Rate) on Follow-up of Hookworm: 3 Months
Eggs per gram of stool will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs.
Time frame: 3 months post-treatment
Population: Geometric mean reduction in number of eggs at baseline and assessed at 3 months post-treatment
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| A: Moxidectin (8 mg) / Albendazole (400 mg) | Extended Effects (Egg Reduction Rate) on Follow-up of Hookworm: 3 Months | 97.6 Percent change |
| B: Ivermectin (200 µg/kg) / Albendazole (400 mg) | Extended Effects (Egg Reduction Rate) on Follow-up of Hookworm: 3 Months | 95.1 Percent change |
| C: Albendazole (400 mg) | Extended Effects (Egg Reduction Rate) on Follow-up of Hookworm: 3 Months | 96.3 Percent change |
| D: Ivermectin (200 µg/kg) | Extended Effects (Egg Reduction Rate) on Follow-up of Hookworm: 3 Months | 56.1 Percent change |
| E: Moxidectin (8 mg) | Extended Effects (Egg Reduction Rate) on Follow-up of Hookworm: 3 Months | 76.7 Percent change |
Secondary
Extended Effects (Egg Reduction Rate) on Follow-up of Hookworm: 5-6 Weeks
Eggs per gram of stool will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs.
Time frame: 5-6 weeks post-treatment
Population: Mean number of participants found positive for hookworm at 5-6 weeks post-treatment
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| A: Moxidectin (8 mg) / Albendazole (400 mg) | Extended Effects (Egg Reduction Rate) on Follow-up of Hookworm: 5-6 Weeks | 98.6 Percent change |
| B: Ivermectin (200 µg/kg) / Albendazole (400 mg) | Extended Effects (Egg Reduction Rate) on Follow-up of Hookworm: 5-6 Weeks | 96.8 Percent change |
| C: Albendazole (400 mg) | Extended Effects (Egg Reduction Rate) on Follow-up of Hookworm: 5-6 Weeks | 94.6 Percent change |
| D: Ivermectin (200 µg/kg) | Extended Effects (Egg Reduction Rate) on Follow-up of Hookworm: 5-6 Weeks | 57.9 Percent change |
| E: Moxidectin (8 mg) | Extended Effects (Egg Reduction Rate) on Follow-up of Hookworm: 5-6 Weeks | 88.7 Percent change |
Secondary
Extended Effects (Egg Reduction Rate) on Follow-up of T. Trichiura: 3 Months
Eggs per gram of stool will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs.
Time frame: 3 months post-treatment
Population: Geometric mean reduction in number of eggs at baseline and assessed at 3 months post-treatment
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| A: Moxidectin (8 mg) / Albendazole (400 mg) | Extended Effects (Egg Reduction Rate) on Follow-up of T. Trichiura: 3 Months | 93.2 Percent change |
| B: Ivermectin (200 µg/kg) / Albendazole (400 mg) | Extended Effects (Egg Reduction Rate) on Follow-up of T. Trichiura: 3 Months | 97.1 Percent change |
| C: Albendazole (400 mg) | Extended Effects (Egg Reduction Rate) on Follow-up of T. Trichiura: 3 Months | 78.2 Percent change |
| D: Ivermectin (200 µg/kg) | Extended Effects (Egg Reduction Rate) on Follow-up of T. Trichiura: 3 Months | 55.4 Percent change |
| E: Moxidectin (8 mg) | Extended Effects (Egg Reduction Rate) on Follow-up of T. Trichiura: 3 Months | 71.9 Percent change |
Secondary
Extended Effects (Egg Reduction Rate) on Follow-up of T. Trichiura: 5-6 Weeks
Eggs per gram of stool will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs.
Time frame: 5-6 weeks post-treatment
Population: Geometric mean reduction in number of eggs at baseline and assessed at 5-6 weeks post-treatment
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| A: Moxidectin (8 mg) / Albendazole (400 mg) | Extended Effects (Egg Reduction Rate) on Follow-up of T. Trichiura: 5-6 Weeks | 97.0 Percent change |
| B: Ivermectin (200 µg/kg) / Albendazole (400 mg) | Extended Effects (Egg Reduction Rate) on Follow-up of T. Trichiura: 5-6 Weeks | 98.3 Percent change |
| C: Albendazole (400 mg) | Extended Effects (Egg Reduction Rate) on Follow-up of T. Trichiura: 5-6 Weeks | 75.7 Percent change |
| D: Ivermectin (200 µg/kg) | Extended Effects (Egg Reduction Rate) on Follow-up of T. Trichiura: 5-6 Weeks | 76.9 Percent change |
| E: Moxidectin (8 mg) | Extended Effects (Egg Reduction Rate) on Follow-up of T. Trichiura: 5-6 Weeks | 85.4 Percent change |
Secondary
Number of Participants With Adverse Events
The observation time for AE starts when the treatment is initiated. Subjects will be kept for observation for at least 3 hours following treatment for any acute AE and. If there is any abnormal finding, the local study physician will perform a full clinical examination and findings will be recorded. An emergency kit will be available on site to treat any medical conditions that warrant urgent medical intervention. Participants will also be interviewed at 3h and 24h as well as retrospectively 14 -21 days, 5-6 weeks and 3 months after treatment about the occurrence of AEs.
Time frame: 3 hours, 24 hours, 14-21 days, 5-6 weeks and 3 months post-treatment
Population: number analyzed corresponds to the number of participants assessed per time point
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| A: Moxidectin (8 mg) / Albendazole (400 mg) | Number of Participants With Adverse Events | Baseline | 7 Participants |
| A: Moxidectin (8 mg) / Albendazole (400 mg) | Number of Participants With Adverse Events | 3h post treatment | 17 Participants |
| A: Moxidectin (8 mg) / Albendazole (400 mg) | Number of Participants With Adverse Events | 24h post treatment | 36 Participants |
| A: Moxidectin (8 mg) / Albendazole (400 mg) | Number of Participants With Adverse Events | 14 to 21 days post treatment | 35 Participants |
| A: Moxidectin (8 mg) / Albendazole (400 mg) | Number of Participants With Adverse Events | 5 to 6 weeks post treatment | 20 Participants |
| A: Moxidectin (8 mg) / Albendazole (400 mg) | Number of Participants With Adverse Events | 3 months post treatment | 10 Participants |
| B: Ivermectin (200 µg/kg) / Albendazole (400 mg) | Number of Participants With Adverse Events | 5 to 6 weeks post treatment | 10 Participants |
| B: Ivermectin (200 µg/kg) / Albendazole (400 mg) | Number of Participants With Adverse Events | 3 months post treatment | 15 Participants |
| B: Ivermectin (200 µg/kg) / Albendazole (400 mg) | Number of Participants With Adverse Events | Baseline | 9 Participants |
| B: Ivermectin (200 µg/kg) / Albendazole (400 mg) | Number of Participants With Adverse Events | 24h post treatment | 40 Participants |
| B: Ivermectin (200 µg/kg) / Albendazole (400 mg) | Number of Participants With Adverse Events | 14 to 21 days post treatment | 41 Participants |
| B: Ivermectin (200 µg/kg) / Albendazole (400 mg) | Number of Participants With Adverse Events | 3h post treatment | 25 Participants |
| C: Albendazole (400 mg) | Number of Participants With Adverse Events | 14 to 21 days post treatment | 4 Participants |
| C: Albendazole (400 mg) | Number of Participants With Adverse Events | 5 to 6 weeks post treatment | 2 Participants |
| C: Albendazole (400 mg) | Number of Participants With Adverse Events | Baseline | 0 Participants |
| C: Albendazole (400 mg) | Number of Participants With Adverse Events | 24h post treatment | 3 Participants |
| C: Albendazole (400 mg) | Number of Participants With Adverse Events | 3h post treatment | 0 Participants |
| C: Albendazole (400 mg) | Number of Participants With Adverse Events | 3 months post treatment | 0 Participants |
| D: Ivermectin (200 µg/kg) | Number of Participants With Adverse Events | 14 to 21 days post treatment | 4 Participants |
| D: Ivermectin (200 µg/kg) | Number of Participants With Adverse Events | 3h post treatment | 2 Participants |
| D: Ivermectin (200 µg/kg) | Number of Participants With Adverse Events | 24h post treatment | 2 Participants |
| D: Ivermectin (200 µg/kg) | Number of Participants With Adverse Events | 3 months post treatment | 2 Participants |
| D: Ivermectin (200 µg/kg) | Number of Participants With Adverse Events | 5 to 6 weeks post treatment | 2 Participants |
| D: Ivermectin (200 µg/kg) | Number of Participants With Adverse Events | Baseline | 0 Participants |
| E: Moxidectin (8 mg) | Number of Participants With Adverse Events | 5 to 6 weeks post treatment | 6 Participants |
| E: Moxidectin (8 mg) | Number of Participants With Adverse Events | 24h post treatment | 6 Participants |
| E: Moxidectin (8 mg) | Number of Participants With Adverse Events | 3h post treatment | 6 Participants |
| E: Moxidectin (8 mg) | Number of Participants With Adverse Events | 3 months post treatment | 4 Participants |
| E: Moxidectin (8 mg) | Number of Participants With Adverse Events | 14 to 21 days post treatment | 13 Participants |
| E: Moxidectin (8 mg) | Number of Participants With Adverse Events | Baseline | 0 Participants |
Secondary
Superiority in Terms of Cure Rates (CRs)
Assessment of superiority in terms of CRs of the drug combinations compared to their corresponding monotherapies: Arm C: Albendazole (400 mg) Arm D: Ivermectin (200 μg/kg) and Arm E: Moxidectin (8 mg). Cure rates is defined as the percentages of participants treated with Moxidectin (8 mg)/Albendazole (400 mg), Ivermectin (200 μg/kg)/Albendazole (400 mg), Albendazole (400 mg), Ivermectin (200 μg/kg) or Moxidectin (8 mg) who were cured of infections with T. trichiura.
Time frame: 14-21 day post-treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| A: Moxidectin (8 mg) / Albendazole (400 mg) | Superiority in Terms of Cure Rates (CRs) | 34.3 Percentage of participants |
| B: Ivermectin (200 µg/kg) / Albendazole (400 mg) | Superiority in Terms of Cure Rates (CRs) | 54.0 Percentage of participants |
| C: Albendazole (400 mg) | Superiority in Terms of Cure Rates (CRs) | 26.3 Percentage of participants |
| D: Ivermectin (200 µg/kg) | Superiority in Terms of Cure Rates (CRs) | 10.5 Percentage of participants |
| E: Moxidectin (8 mg) | Superiority in Terms of Cure Rates (CRs) | 11.2 Percentage of participants |