NCT01213433CompletedPhase 4
Amodiaquine+Artesunate for the Treatment of Uncomplicated Falciparum Malaria in Nanoro, Burkina Faso
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Centre Muraz
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Treatment failure at day 28
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 6 Months to — (Child, Adult, Older Adult)
- Sex
- All
- 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).
Arms & Interventions
Amodiaquine+Artesunate
Experimental
Intervention: Artesunate-Amodiaquine (Drug)
Outcomes
Primary Outcomes
Treatment failure at day 28
Time Frame: 28 days
Secondary Outcomes
No secondary outcomes reported
Investigators
Tinto Halidou
PharmD, PhD
Centre Muraz
Study Sites (1)
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