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Efficacy and Safety of Moxidectin-Albendazole Co-administration in SAC

NCT06188715 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2025-09-19

Study results available
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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.

Conditions

  • Trichuriasis
  • Ascariasis
  • Hookworm Infections

Interventions

DRUG

Moxidectin 2 mg Oral Tablet

Tablets of 2 mg moxidectin

DRUG

Albendazole 400 mg Oral Tablet

Tablets of 400 mg albendazole

DRUG

Placebo Moxidectin

Placebo tablets for moxidectin

DRUG

Placebo Albendazole

Placebo tablets for albendazole

Sponsors & Collaborators

  • Public Health Laboratory Ivo de Carneri

    collaborator OTHER

  • Jennifer Keiser

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-14
Primary Completion
2024-08-05
Completion
2024-08-05
FDA Drug
Yes

Countries

  • Tanzania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06188715 on ClinicalTrials.gov