Artemether-lumefantrine (AL) Versus Artesunate + Amodiaquine (ASAQ) for the Treatment of Uncomplicated Falciparum Malaria in Burkina Faso

Phase 4

Completed

• Conditions: Uncomplicated P. Falciparum Malaria in Children
• Interventions: Drug: Artesunate-amodiaquine; Drug: Artemether-lumefantrine

• Registration Number: NCT01017770
• Lead Sponsor: Centre Muraz

Brief Summary

Several countries in Africa have changed their first-line treatment for uncomplicated malaria to an ACT. Burkina Faso has changed its policy to Artemether-Lumefantrine (AL) and Artesunate-Amodiaquine (AQ+AS). However, such choice has been done without knowing the local effectiveness of these drugs when they are given to patients in real life conditions, without direct observation of the drug administration. Thus, this study aims at investigating the effectiveness of AQ+AS and AL, when given to children with uncomplicated malaria in Burkina Faso.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2009-11-20
• Study First Submitted QC: 2009-11-20
• Study First Posted: 2009-11-23
• Primary Completion: 2010-01
• Study Completion: 2010-08
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-29
• Last Update Posted: 2015-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 340

Inclusion Criteria

• Weight > 5 kg;
• Monoinfection with P. falciparum and a parasitaemia of 2,000-200,000 parasites /µl;
• Fever (axillary temperature ≥37.5 °C) or history of fever in the preceding 24 hours;
• Haemoglobin value above 5.0 g/dl;
• Absence of febrile conditions caused by diseases other than malaria.

Exclusion Criteria

• Danger signs: not able to drink or breast-feed, vomiting (> twice in 24hours), recent history of convulsions (>1 in 24h), unconscious state, unable to sit or stand;
• Signs of severe malaria (WHO 2000);
• Mixed malaria infection;
• Severe malnutrition;
• Other underlying diseases (cardiac, renal, hepatic diseases);
• History of allergy to study drugs;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Artesunate-amodiaquine	Artesunate-amodiaquine	Treatment of malaria with Artesunate-amodiaquine(AS-AQ), according to one of the two options given by national protocol in Burkina Faso
Artemether -lumefantrine	Artemether-lumefantrine	Experimental Treatment of malaria with Artemether-lumefantrine (AL), according to one of the two options given by national protocol in Burkina Faso

Primary Outcome Measures

Name	Time	Method
Polymerase chain reaction (PCR) adjusted treatment failure	Day 28

Secondary Outcome Measures

Name	Time	Method
Treatment failure up to day 42 (PCR adjusted and unadjusted)	Day 42
Gametocytes (prevalence and density)	At day 7, 14, 21, 28, 35 and 42 days after treatment
Hb changes	Day 35

Trial Locations

Locations (3)

Tinto Halidou; 🇧🇫 Bobo-Dioulasso, Houet, Burkina Faso

Nanoro; 🇧🇫 Nanoro, Boulkiemdé, Burkina Faso

IRSS-DRO/Centre Muraz; 🇧🇫 Bobo-Dioulasso, Bp 545, Burkina Faso