Amodiaquine-Artesunate & Artemether-Lumefantrine Efficacy in Burkina Faso

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Muraz
• Collaborator: Institute of Tropical Medicine, Belgium
• Treatments: Amodiaquine; Artemether; Artemether-lumefantrine combination; Artemether, Lumefantrine Drug Combination; Artemisinins; Artesunate; Lumefantrine

Criteria

Inclusion Criteria:

• Age above 6 months,

• eight above 5 kg;

• Positive blood slide (parasitaemia ≥ 2,000/μL to 200,000/μL) with Plasmodium falciparum monospecific infection ;

• Fever (axillary temperature above 37.5 °C) or history of fever in the preceding 24 hours;

• Haemoglobin value above or equal 5.0 g/dL

• Signed informed consent;

• Willingness and ability to comply with the study protocol for the duration of the trial.

Exclusion Criteria:

• Participation in any other investigational drug study (antimalarial or others) during the previous 30 days

• Known hypersensitivity to the study drugs

• Severe malaria

• Danger signs: not able to drink or breast-feed, vomiting (> twice in 24hours), recent history of convulsions (more than 1 in 24h), unconscious state, unable to sit or stand;

• Known intercurrent illness or any condition (cardiac, renal, hepatic diseases) which would place the subject at undue risk or interfere with the results of the study.

• Severe malnutrition (defined as weight for height less than 70% of the median NCHS/WHO reference)

• Known pregnancy