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

This study has been completed.
Sponsor:
Collaborator:
Institute of Tropical Medicine, Belgium
Information provided by:
Centre Muraz
ClinicalTrials.gov Identifier:
NCT01017770
First received: November 20, 2009
Last updated: November 1, 2010
Last verified: November 2010

November 20, 2009
November 1, 2010
September 2008
January 2010   (final data collection date for primary outcome measure)
Polymerase chain reaction (PCR) adjusted treatment failure [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01017770 on ClinicalTrials.gov Archive Site
  • Treatment failure up to day 42 (PCR adjusted and unadjusted) [ Time Frame: Day 42 ] [ Designated as safety issue: Yes ]
  • Gametocytes (prevalence and density) [ Time Frame: At day 7, 14, 21, 28, 35 and 42 days after treatment ] [ Designated as safety issue: Yes ]
  • Hb changes [ Time Frame: Day 35 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Artemether-lumefantrine (AL) Versus Artesunate + Amodiaquine (ASAQ) for the Treatment of Uncomplicated Falciparum Malaria in Burkina Faso
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Uncomplicated P. Falciparum Malaria in Children
  • 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
  • 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: Artemether -lumefantrine
    Experimental Treatment of malaria with Artemether-lumefantrine (AL), according to one of the two options given by national protocol in Burkina Faso
    Intervention: Drug: Artemether-lumefantrine
  • 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
    Intervention: Drug: Artesunate-amodiaquine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
340
August 2010
January 2010   (final data collection date for primary outcome measure)

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;
Both
6 Months to 59 Months
No
Contact information is only displayed when the study is recruiting subjects
Burkina Faso
 
NCT01017770
ACTEffectiveness
No
Dr Tinto Halidou, IRSS-DRO/Centre Muraz
Centre Muraz
Institute of Tropical Medicine, Belgium
Not Provided
Centre Muraz
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP