Status:
COMPLETED
Amodiaquine+Artesunate for Uncomplicated Malaria Treatment
Lead Sponsor:
Centre Muraz
Collaborating Sponsors:
Institute of Tropical Medicine, Belgium
Conditions:
Uncomplicated Malaria
Eligibility:
All Genders
6+ years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01213433
Start Date
October 1 2010
End Date
April 1 2011
Last Update
July 31 2015
Active Locations (1)
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1
CRUN
Nanoro, Boulkiemdé, Burkina Faso, 01