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

This study has been completed.
Sponsor:
Collaborator:
Institute of Tropical Medicine, Belgium
Information provided by:
Centre Muraz
ClinicalTrials.gov Identifier:
NCT01213433
First received: September 30, 2010
Last updated: June 9, 2011
Last verified: November 2010

September 30, 2010
June 9, 2011
October 2010
November 2010   (final data collection date for primary outcome measure)
Treatment failure at day 28 [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01213433 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
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).
Both
6 Months and older
No
Contact information is only displayed when the study is recruiting subjects
Burkina Faso
 
NCT01213433
016-2010
No
Tinto Halidou, Pharmd, PhD, 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