Amodiaquine+Artesunate for Uncomplicated Malaria Treatment (ASAQ-MAL)

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: NCT01213433
Recruitment Status : Completed
First Posted : October 4, 2010
Last Update Posted : July 31, 2015
Institute of Tropical Medicine, Belgium
Information provided by (Responsible Party):
Tinto Halidou, Centre Muraz

September 30, 2010
October 4, 2010
July 31, 2015
October 2010
November 2010   (Final data collection date for primary outcome measure)
Treatment failure at day 28 [ Time Frame: 28 days ]
Same as current
Complete list of historical versions of study NCT01213433 on Archive Site
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Amodiaquine+Artesunate for Uncomplicated Malaria Treatment
Amodiaquine+Artesunate for the Treatment of Uncomplicated Falciparum Malaria in Nanoro, Burkina Faso
This is a phase IV one-arm study aiming at recruiting 50 patients to assess the efficacy of AQ+AS in patients with a positive RDT diagnosis of malaria in Nanoro, Burkina Faso.
Not Provided
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Uncomplicated Malaria
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)
Experimental: Amodiaquine+Artesunate
Intervention: Drug: Artesunate-Amodiaquine
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
April 2011
November 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Males and Females aged 6 months and above.
  • Body weight of 5 Kg and above.
  • RDT positive test.
  • Fever (axillary temperature at ≥ 37.5°C) or history of fever in the previous 24 hours.
  • Signed (or thumb-printed whenever patients are illiterate) informed consent.
  • Patients' willingness and ability to comply with the study protocol for the duration of the study.

Exclusion Criteria:

  • Participation in any other investigational drug study (antimalarial or others) during the previous 30 days.
  • Known hypersensitivity to the study drugs.
  • Severe malaria.
  • 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.
  • Known intercurrent illness or any condition (cardiac, renal, hepatic diseases) which in the judgement of the investigator would place the subject at undue risk or interfere with the results of the study.
  • Severe malnutrition (defined as weight for height <70% of the median NCHS/WHO reference).
Sexes Eligible for Study: All
6 Months and older   (Child, Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Burkina Faso
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Tinto Halidou, Centre Muraz
Centre Muraz
Institute of Tropical Medicine, Belgium
Not Provided
Centre Muraz
July 2015

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