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Efficacy and Safety of MOX/ALB Co-administration

NCT04726969 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 255

Last updated 2024-01-24

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 versus albendazole monotherapy (standard of care) against whipworm (T. trichiura) infections in adolescents and adults (12-60 years) in Côte d'Ivoire. One arm of patients will be treated with albendazole-ivermectin.

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

Ivermectin 3 mg Oral Tablet

Tablets of 3 mg ivermectin

Sponsors & Collaborators

  • Centre Suisse de Recherches Scientifiques en Cote d'Ivoire

    collaborator OTHER

  • Jennifer Keiser

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-06-15
Primary Completion
2021-09-09
Completion
2021-09-09
FDA Drug
Yes

Countries

  • Côte d’Ivoire

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 NCT04726969 on ClinicalTrials.gov