Phase 3
N=224
Efficacy and Safety of Moxidectin-Albendazole Co-administration in SAC
Trichuriasis · Ascariasis · Hookworm Infections
Bottom Line
View on ClinicalTrials.gov: NCT06188715 ↗Enrolled (actual)
224
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcome: Primary: Cure Rate (CR) Against T. Trichiura — 69.4; 16.2; 11.8 percentage of participants cured (%)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Moxidectin 2 mg Oral Tablet (Drug); Albendazole 400 mg Oral Tablet (Drug); Placebo Moxidectin (Drug); Placebo Albendazole (Drug)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- Jennifer Keiser
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cure Rate (CR) Against T. Trichiura |
69.4; 16.2; 11.8 | — |
| SECONDARY Egg Reduction Rate (ERR) Against T. Trichiura (Geometric Mean ERR) |
99.1; 64.4; 14.6 | — |
| SECONDARY Egg Reduction Rate (ERR) Against T. Trichiura (Arithmetic Mean ERR) |
91.1; -12.9; -123.9 | — |
| SECONDARY Cure Rate (CR) Against A. Lumbricoides |
97.2; 100.0; 40.0 | — |
| SECONDARY Egg Reduction Rate (ERR) Against A. Lumbricoides (Geometric Mean ERR) |
99.9; 100.0; 85.0 | — |
| SECONDARY Egg Reduction Rate (ERR) Against A. Lumbricoides (Arithmetic Mean ERR) |
88.2; 100.0; -17.5 | — |
| SECONDARY Cure Rate (CR) Against Hookworm |
83.0; 65.4; 7.7 | — |
| SECONDARY Egg Reduction Rate (ERR) Against Hookworm (Geometric Mean ERR) |
99.3; 97.8; -24.5 | — |
| SECONDARY Egg Reduction Rate (ERR) Against Hookworm (Arithmetic Mean ERR) |
95.9; 87.3; -113.0 | — |
| SECONDARY Number of Participants Reporting Adverse Events (AEs) |
4; 2; 1; 0; 0; 1 | — |
Summary
This study is a double-blind randomized controlled superiority trial aiming at providing evidence on the efficacy and safety of co-administered moxidectin and albendazole compared to albendazole monotherapy in school-aged children (SAC; aged 6-12 years) infected with whipworm (Trichuris trichiura) on Pemba Island, Tanzania. Additionally, evidence on the safety profile of moxidectin-albendazole combination in this age group will be substantiated using a placebo (and albendazole) only arm. To date, this has only been established in adolescents (aged 16-18 years), who might present different symptoms or symptom severity compared with SAC.
As measure of efficacy of the treatment the cure rate (percentage of egg-positive subjects at baseline who become egg-negative after treatment) will be determined 14-21 days post-treatment.
Eligibility Criteria
Inclusion Criteria
- individuals aged 6-12 years (confirmed by birth certificate or similar document)
- having given written informed consent signed by parents/caregivers
- being able and willing to provide two stool samples at baseline and at follow-up assessment (14-21 days)
- having at least two out of four Kato-Katz slides positive for T. trichiura at baseline
- being able and willing to be examined by a study physician before and after treatment
Exclusion Criteria
- presence or signs of major systemic illness, e.g. fever (temporal body temperature of >38.0°C), severe anaemia (haemoglobin level of <80 g/l)
- history of severe acute disease or unmanaged, severe chronic disease (i.e., condition is not as therapeutically controlled as necessary)
- use of anthelminthic drugs during study period
- known allergy to study medication (i.e., moxidectin or albendazole)
- being prescribed or taking concomitantly medication with known contraindications or drug interactions with the study medication
- pregnancy (female participants aged 10-12 years)
- concurrent participation in other clinical trials
Data sourced from ClinicalTrials.gov (NCT06188715). 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.