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

History of Changes

Tracking Information
First Received Date ^ICMJE	September 30, 2010
Last Updated Date	June 9, 2011
Start Date ^ICMJE	October 2010
Primary Completion Date	November 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 1, 2010)	Treatment failure at day 28 [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01213433 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Amodiaquine+Artesunate for Uncomplicated Malaria Treatment
Official Title ^ICMJE	Amodiaquine+Artesunate for the Treatment of Uncomplicated Falciparum Malaria in Nanoro, Burkina Faso
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Uncomplicated Malaria
Intervention ^ICMJE	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)
Study Arm (s)	Experimental: Amodiaquine+Artesunate Intervention: Drug: Artesunate-Amodiaquine
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	50
Completion Date	April 2011
Primary Completion Date	November 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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).
Gender	Both
Ages	6 Months and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Burkina Faso

Administrative Information
NCT Number ^ICMJE	NCT01213433
Other Study ID Numbers ^ICMJE	016-2010
Has Data Monitoring Committee	No
Responsible Party	Tinto Halidou, Pharmd, PhD, Centre Muraz
Study Sponsor ^ICMJE	Centre Muraz
Collaborators ^ICMJE	Institute of Tropical Medicine, Belgium
Investigators ^ICMJE	Not Provided
Information Provided By	Centre Muraz
Verification Date	November 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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