Antimalaria Drugs Susceptibility Testing for an Effective Management of Infected Patients in Sub-Sahara Africa
Status:
Completed
Trial end date:
2014-10-01
Target enrollment:
Participant gender:
Summary
The antimalarial drugs efficacy and safety study will be conducted in the Clinics and
hospital of the Cameroon Development Corporation (CDC) Estates, Tiko Health District, located
in a typical forest and rainfall area in the South West Region Cameroon. In this study, 350
children aged 6 months to 5 years who are found to have uncomplicated symptomatic malaria
will be enrolled between October 2012 and March 2013. Participants will be randomized to
receive one of the following medications.
(i) DHA+PQ : dihydroartemisinin, 2.5 mg per kg, plus piperaquine phosphate, 20mg per kg daily
for 3 days; (ii) ART LUM : Artemether, 2mg per kg, plus lumefantrine 10mg, twice daily for 3
days; (iii) AS+MQ: artesunate, 4 mg/kg/day, with mefloquine, 8 mg/kg/day orally once a day
for 3 days.
All study medications will be administered orally The Primary objective of this study are to
compare the efficacy, safety and tolerability of orally administered artemether plus
lumefantrine (ART+LUM), artesunate plus mefloquine (AS+MQ) and dihydroartemisinin plus
piperaquine (DHA+PQ) combinations in the treatment of uncomplicated falciparum malaria in
Cameroon in order to provide evidence that can be used to determining the optimum antimalaria
treatment policy in Cameroon. The secondary objectives are as follows (i) To valuate the
efficacy and safety of artemether plus lumefantrine (ART + LUM) and artesunate plus
mefloquine (AS + MQ) versus dihydroartemisinin plus piperaquine (DHA + PQ) combination (ii)
To compare the clearance of asexual parasites and gametocytes in each treatment arm (iii) To
assess the clearance of fever (iv) Assess effect of each treatment arm on anemia This study
is a randomized, double blinded clinical trial. After enrollment, participant will be
randomized to one of the three treatment regimen. The treatment outcome will be assessed
through a 42-day efficacy study. Participants who will exhibit early or late treatment
failure and those with adequate clinical response and parasitological failure on day 14, 28
or 42 will be treated with quinine (25mg base per kg body weight per day in three divided
doses for five days). In addition to antimalarial drugs oral paracetamol (50mg/kg body weight
per day in three divided doses) will be administered for fever exceeding 37.5%. Polymerase
Chain Reaction (PCR) -corrected 28 day and 42 day efficacy will be evaluated for each
treatment episode.
Phase:
Phase 3
Details
Lead Sponsor:
University of Bamenda
Collaborators:
Ministry of Science and Technology of the People´s Republic of China National Institute for Parasitic Disease, Chinese Center for Disease Control and Prevention