Safety and Efficacy Study of Artesunate and Mefloquin in Children With Uncomplicated Malaria
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."
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase IV Study on the Safety and Effectiveness of a Fixed-dose Combination of Artesunate and Mefloquine (Artequin[TM] Paediatric) Administered for 3 Days in Children With Uncomplicated Plasmodium Falciparum Malaria in Africa|
- To assess the neuropsychiatric and neurological safety of a fixed-dose combination of artesunate and mefloquine (Artequin Paediatric) in the treatment of children (>=10kg to <=20kg body weight) with uncomplicated P. falciparum malaria [ Time Frame: Baseline (day1), day 7, day 28, day 63 ] [ Designated as safety issue: No ]
- To determine further safety and effectiveness parameters of Artequin Paediatric [ Time Frame: Baseline (day1), day 4, day7, day 28, day 63 ] [ Designated as safety issue: No ]
|Study Start Date:||December 2007|
|Study Completion Date:||March 2009|
Drug: artesunate and mefloquine
The study aims investigating the safety profile of Artequin Paediatric in a 3-day treatment of children with uncomplicated P. falciparum malaria under "real life conditions" in West Africa. Important parameters, such as concomitant medication, the patient's medical history and diseases, differential WBC counts, the presence of parasitaemia as well as the patient's compliance are evaluated. Detailed recording of possible AEs and SAEs enable additionally an assessment of the safety and effectiveness of Artequin Paediatric over a period of 63 days following treatment initiation. The present study primarily serves to detect and assess possible neuropsychiatric and neurological events in young children using a standardized questionnaire and axamination.
|Centre Mère et Enfant, Fondation Chantal Biya|
|Yaounde, Cameroon, BP 1936|
|Principal Investigator:||Felix Tietche, Prof||Faculty of Medicine and Biomedical Sciences University of Yaounde (Cameroon)|