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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

340 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2010-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Uncomplicated P. Falciparum Malaria in Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Artemether -lumefantrine

Experimental Treatment of malaria with Artemether-lumefantrine (AL), according to one of the two options given by national protocol in Burkina Faso

Group Type EXPERIMENTAL

Artemether-lumefantrine

Intervention Type DRUG

Artemether-lumefantrine by Novartis was the first fixed-dose ACT that was prequalified by WHO in April 2004. A 3-day, 6-dose regimen of AL is recommended for infants and children weighing 5-35 kg and adults weighing \> 35 kg.

Artesunate-amodiaquine

Treatment of malaria with Artesunate-amodiaquine(AS-AQ), according to one of the two options given by national protocol in Burkina Faso

Group Type EXPERIMENTAL

Artesunate-amodiaquine

Intervention Type DRUG

Coformulated AQ+AS by Sanofi-Aventis has been pre-qualified by WHO in 2008. It is administered once daily for three consecutive days, and it is available in three different dosages (25mg/67.5mg; 50mg/135mg; 100mg/270mg)

Interventions

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Artesunate-amodiaquine

Coformulated AQ+AS by Sanofi-Aventis has been pre-qualified by WHO in 2008. It is administered once daily for three consecutive days, and it is available in three different dosages (25mg/67.5mg; 50mg/135mg; 100mg/270mg)

Intervention Type DRUG

Artemether-lumefantrine

Artemether-lumefantrine by Novartis was the first fixed-dose ACT that was prequalified by WHO in April 2004. A 3-day, 6-dose regimen of AL is recommended for infants and children weighing 5-35 kg and adults weighing \> 35 kg.

Intervention Type DRUG

Other Intervention Names

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ASAQ, Coarsucam AL, Coartem(R), Riamet(R)

Eligibility Criteria

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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;

Minimum Eligible Age

6 Months

Maximum Eligible Age

59 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No