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Efficacy and Safety of IVM/ALB Co-administration

NCT03527732 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 1673

Last updated 2024-03-20

Study results available
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Summary

This study is a double-blind randomized clinical trial conducted with two settings in Africa and one in Asia, namely Côte d'Ivoire, Pemba (Zanzibar, Tanzania) and Lao PDR. This study aims at providing evidence on the efficacy and safety of co-administered albendazole and ivermectin versus albendazole monotherapy (standard of care) against whipworm (T. trichiura) infections in children and adults (6-60 years).

The efficacy of the treatment and potential extended effects on follow-up prevalence will be determined 14-21 days, 6 months and 12 months post-treatment by collecting another two stool samples. The cure rate will be calculated as the percentage of egg-positive subjects at baseline who become egg-negative after treatment.

Conditions

  • Trichuriasis

Interventions

DRUG

Albendazole

Monotherapy of albendazole (400 mg)

DRUG

Albendazole and Ivermectin

Combination therapy of albendazole (400 mg) and ivermectin (200 µg/kg)

Sponsors & Collaborators

  • Centre Suisse de Recherches Scientifiques en Cote d'Ivoire

    collaborator OTHER

  • Lao Tropical and Public Health Institute

    collaborator OTHER_GOV

  • Public Health Laboratory of Pemba, Tanzania

    collaborator OTHER

  • Jennifer Keiser

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-09-09
Primary Completion
2020-05-15
Completion
2020-07-15

Countries

  • Côte d’Ivoire
  • Laos
  • 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 NCT03527732 on ClinicalTrials.gov