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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01017770
Recruitment Status : Completed
First Posted : November 23, 2009
Last Update Posted : July 31, 2015
Institute of Tropical Medicine, Belgium
Information provided by (Responsible Party):
Tinto Halidou, 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.

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

Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 2008
Primary Completion Date : January 2010
Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria
U.S. FDA Resources

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 Name: 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 Name: ASAQ, Coarsucam

Primary Outcome Measures :
  1. Polymerase chain reaction (PCR) adjusted treatment failure [ Time Frame: Day 28 ]

Secondary Outcome Measures :
  1. Treatment failure up to day 42 (PCR adjusted and unadjusted) [ Time Frame: Day 42 ]
  2. Gametocytes (prevalence and density) [ Time Frame: At day 7, 14, 21, 28, 35 and 42 days after treatment ]
  3. Hb changes [ Time Frame: Day 35 ]

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Ages Eligible for Study:   6 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01017770

Burkina Faso
Nanoro, Boulkiemdé, Burkina Faso, 115
Nanoro, Boulkiemdé, Burkina Faso
IRSS-DRO/Centre Muraz
Bobo-Dioulasso, Bp 545, Burkina Faso, 01
Tinto Halidou
Bobo-Dioulasso, Houet, Burkina Faso, 01
Sponsors and Collaborators
Centre Muraz
Institute of Tropical Medicine, Belgium

Responsible Party: Tinto Halidou, PharmD, PhD, Centre Muraz Identifier: NCT01017770     History of Changes
Other Study ID Numbers: ACTEffectiveness
First Posted: November 23, 2009    Key Record Dates
Last Update Posted: July 31, 2015
Last Verified: July 2015

Keywords provided by Tinto Halidou, Centre Muraz:
Uncomplicated malaria

Additional relevant MeSH terms:
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Artemether-lumefantrine combination
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antifungal Agents
Antiplatyhelmintic Agents