Amodiaquine+Artesunate for Uncomplicated Malaria Treatment
Phase 4
Completed
- Conditions
- Uncomplicated Malaria
- Interventions
- Drug: Artesunate-Amodiaquine
- Registration Number
- NCT01213433
- Lead Sponsor
- Centre Muraz
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Amodiaquine+Artesunate Artesunate-Amodiaquine -
- Primary Outcome Measures
Name Time Method Treatment failure at day 28 28 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
CRUN
🇧🇫Nanoro, Boulkiemdé, Burkina Faso