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

This study has been completed.
Institute of Tropical Medicine, Belgium
Information provided by (Responsible Party):
Tinto Halidou, Centre Muraz Identifier:
First received: September 30, 2010
Last updated: July 29, 2015
Last verified: July 2015
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.

Condition Intervention Phase
Uncomplicated Malaria
Drug: Artesunate-Amodiaquine
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Amodiaquine+Artesunate for the Treatment of Uncomplicated Falciparum Malaria in Nanoro, Burkina Faso

Resource links provided by NLM:

Further study details as provided by Centre Muraz:

Primary Outcome Measures:
  • Treatment failure at day 28 [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: October 2010
Study Completion Date: April 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Amodiaquine+Artesunate 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)


Ages Eligible for Study:   6 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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).
  Contacts and Locations
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Please refer to this study by its identifier: NCT01213433

Burkina Faso
Nanoro, Boulkiemdé, Burkina Faso, 01
Sponsors and Collaborators
Centre Muraz
Institute of Tropical Medicine, Belgium
  More Information

No publications provided

Responsible Party: Tinto Halidou, PharmD, PhD, Centre Muraz Identifier: NCT01213433     History of Changes
Other Study ID Numbers: 016-2010
Study First Received: September 30, 2010
Last Updated: July 29, 2015
Health Authority: Burkina Faso: Ministry of Health

Additional relevant MeSH terms:
Parasitic Diseases
Protozoan Infections
Anti-Infective Agents
Antiparasitic Agents
Antiprotozoal Agents
Pharmacologic Actions
Therapeutic Uses processed this record on November 24, 2015