Efficacy and Safety of Moxidectin-Albendazole Co-administration in SAC
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.
Timeline
- Start
- 2024-05-14
- Primary completion
- 2024-08-05
- Completion
- 2024-08-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Albendazole | Small molecule | 400 mg | Oral |
| Subject | Moxidectin | Other / unclassified | 4 mg | Oral |
| Subject | Moxidectin | Other / unclassified | 8 mg | Oral |