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Amodiaquine-Artesunate & Artemether-Lumefantrine Efficacy in Burkina Faso

NCT01697787 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2015-07-31

No results posted yet for this study

Summary

This is a two-arm study aiming at recruiting 150 patients to assess the efficacy of Amodiaquine-Artesunate (ASAQ) and Artemether-Lumefantrine (AL) in patients with a microscopy positive diagnosis of malaria in Nanoro, Burkina Faso and assess the performance of the Rapid Diagnosis Tests (RDTs) compared to the microscopy.

Conditions

Interventions

DRUG

Amodiaquine-Artesunate

If necessary, the study drug will be crushed, dissolved in water and squirted into the mouth using a spoonful. Administration of the treatments will be directly observed. After drug administration, patients will be kept for at least 30 minutes in the clinic. A dose will be repeated in full if vomiting occurs within 30 minutes of administration and halved if vomiting is between 30 minutes and 1 hour post dosing.

DRUG

Artemether-lumefantrine

If necessary, the study drug will be crushed, dissolved in water and squirted into the mouth using a spoonful. Administration of the treatments will be directly observed. After drug administration, patients will be kept for at least 30 minutes in the clinic. A dose will be repeated in full if vomiting occurs within 30 minutes of administration and halved if vomiting is between 30 minutes and 1 hour post dosing.

Sponsors & Collaborators

  • Institute of Tropical Medicine, Belgium

    collaborator OTHER

  • Centre Muraz

    lead OTHER

Principal Investigators

  • Halidou Tinto, PharmD, PhD · IRSS/Centre Muraz

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • Burkina Faso

Study Locations

More Related Trials

Entities

Diseases

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 NCT01697787 on ClinicalTrials.gov