Safety and Efficacy Study of Artesunate and Mefloquin in Children With Uncomplicated Malaria
NCT00978172 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 220
Last updated 2009-09-16
Summary
The present study aims to investigate and to assess possible neurological and neuropsychiatric events in young children in west Africa with uncomplicated P. falciparum malaria after a 3-day treatment of Artequin Paediatric under "real life conditions."
Conditions
Interventions
- DRUG
-
artesunate and mefloquine
artesunate (50 mg/day) and mefloquine (125 mg/day) fixed dose formulation (stick pack) once daily for 3 consecutive days, orally
Sponsors & Collaborators
-
Centre Mère et Enfant de la Fondation Chantal Biya
collaborator OTHER -
Mepha Ltd.
lead INDUSTRY
Principal Investigators
-
Felix Tietche, Prof · Faculty of Medicine and Biomedical Sciences University of Yaounde (Cameroon)
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-12-31
- Completion
- 2009-03-31
Countries
- Cameroon
Study Locations
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