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

Sponsor

Centre Muraz (Other)

Overall Status

Completed

CT.gov ID

NCT01017770

Collaborator

Institute of Tropical Medicine, Belgium (Other)

340

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

3.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Uncomplicated P. Falciparum Malaria in Children	Drug: Artesunate-amodiaquine Drug: Artemether-lumefantrine	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

340 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Artemether-lumefantrine Vs Co-formulated Amodiaquine + Artesunate for the Treatment of Uncomplicated Falciparum Malaria: a Randomized Open-label Trial to Evaluate the Effectiveness of the Burkina Faso New Drug Policy

Study Start Date :

Sep 1, 2008

Actual Primary Completion Date :

Jan 1, 2010

Actual Study Completion Date :

Aug 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Artemether -lumefantrine Experimental Treatment of malaria with Artemether-lumefantrine (AL), according to one of the two options given by national protocol in Burkina Faso	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. Other Names: AL, Coartem(R), Riamet(R)
Experimental: Artesunate-amodiaquine Treatment of malaria with Artesunate-amodiaquine(AS-AQ), according to one of the two options given by national protocol in Burkina Faso	Drug: 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) Other Names: ASAQ, Coarsucam

Arm

Intervention/Treatment

Experimental: Artemether -lumefantrine

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

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.

Other Names:

AL, Coartem(R), Riamet(R)

Experimental: Artesunate-amodiaquine

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

Drug: 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)

Other Names:

ASAQ, Coarsucam

Outcome Measures

Primary Outcome Measures

Polymerase chain reaction (PCR) adjusted treatment failure [Day 28]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 59 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nanoro	Nanoro	Boulkiemdé	Burkina Faso	115
2	Nanoro	Nanoro	Boulkiemdé	Burkina Faso
3	IRSS-DRO/Centre Muraz	Bobo-Dioulasso	Bp 545	Burkina Faso	01
4	Tinto Halidou	Bobo-Dioulasso	Houet	Burkina Faso	01