Phase 3
N=536
Efficacy and Safety of MOX/ALB vs. IVM/ALB Co-administration
Trichuriasis · Ascariasis · Hookworm Infections · Helminthes; Infestation, Intestinal
Bottom Line
View on ClinicalTrials.gov: NCT04700423 ↗Enrolled (actual)
536
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Egg Reduction Rate Against T. Trichiura — 96.8; 99.0; 86.2; 94.2 Percent change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- moxidectin (8 mg) / albendazole (400 mg) (Drug); ivermectin (200 µg/kg) / albendazole (400 mg) (Drug); ALBENDAZOLE 400 Mg ORAL TABLET [ZENTEL] (Drug); ivermectin (200 µg/kg) (Drug); moxidectin (8 mg) (Drug)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- All
- Sponsor
- Jennifer Keiser
- Primary completion
- Aug 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Egg Reduction Rate Against T. Trichiura |
96.8; 99.0; 86.2; 94.2; 85.5 | — |
| SECONDARY Number of Participants With Adverse Events |
7; 9; 0; 0; 0; 17 | — |
| SECONDARY Superiority in Terms of Cure Rates (CRs) |
34.3; 54.0; 26.3; 10.5; 11.2 | — |
| SECONDARY Cure Rates Against T. Trichiura |
34.3; 54.0; 26.3; 10.5; 11.2 | — |
| SECONDARY Extended Effects (Egg Reduction Rate) on Follow-up of T. Trichiura: 5-6 Weeks |
97.0; 98.3; 75.7; 76.9; 85.4 | — |
| SECONDARY Extended Effects (Cure Rate) on Follow-up of T. Trichiura: 5-6 Weeks |
37.4; 46.4; 16.7; 0.0; 11.2 | — |
| SECONDARY Extended Effects (Egg Reduction Rate) on Follow-up of T. Trichiura: 3 Months |
93.2; 97.1; 78.2; 55.4; 71.9 | — |
| SECONDARY Extended Effects (Cure Rates) on Follow-up of T. Trichiura: 3 Months |
27.4; 39.5; 11.1; 0.0; 9.1 | — |
| SECONDARY Egg Reduction Rates Against Concomitant Soil-transmitted Helminth Infections: Hookworm |
98.8; 97.4; 100.0; 61.9; 81.2 | — |
| SECONDARY Cure Rates Against Concomitant Soil-transmitted Helminth Infections: Hookworm |
75.0; 62.9; 100.0; 25.0; 32.1 | — |
| SECONDARY Extended Effects (Egg Reduction Rate) on Follow-up of Hookworm: 5-6 Weeks |
98.6; 96.8; 94.6; 57.9; 88.7 | — |
| SECONDARY Extended Effects (Cure Rate) on Follow-up of Hookworm: 5-6 Weeks |
71.9; 61.4; 66.7; 25.0; 42.9 | — |
| SECONDARY Extended Effects (Egg Reduction Rate) on Follow-up of Hookworm: 3 Months |
97.6; 95.1; 96.3; 56.1; 76.7 | — |
| SECONDARY Extended Effects (Cure Rate) on Follow-up of Hookworm: 3 Months |
66.1; 60.0; 66.7; 25.0; 32.0 | — |
| SECONDARY Egg Reduction Rates Against Concomitant Soil-transmitted Helminth Infections: Ascaris Lumbricoides |
100.0; 100.0; 100.0; 100.0; 100.0 | — |
| SECONDARY Cure Rates Against Concomitant Soil-transmitted Helminth Infections: Ascaris Lumbricoides |
100.0; 96.4; 91.7; 100.0; 98.0 | — |
| SECONDARY Extended Effects (Egg Reduction Rate) on Follow-up of A. Lumbricoides: 5-6 Weeks |
100.0; 100.0; 100.0; 100.0; 100.0 | — |
| SECONDARY Extended Effects (Cure Rate) on Follow-up of A. Lumbricoides: 5-6 Weeks |
100.0; 100.0; 100.0; 100.0; 98.0 | — |
| SECONDARY Extended Effects (Egg Reduction Rate) on Follow-up of A. Lumbricoides: 3 Months |
100.0; 100.0; 100.0; 100.0; 100.0 | — |
| SECONDARY Extended Effects (Cure Rate) on Follow-up of A. Lumbricoides: 3 Months |
87.3; 88.2; 91.7; 92.9; 87.5 | — |
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).
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04700423). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.