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drugset / Trial / NCT02974348

Antimalaria Drugs Susceptibility Testing for an Effective Management of Infected Patients in Sub-Sahara Africa

NCT02974348 ↗

Phase 3 Completed 300 enrolled University of Bamenda Ministry of Science and Technology of the People´s Republic of China · collabNational Institute for Parasitic Disease, Chinese Center for Disease Control and Prevention · collab
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2013-01
Primary completion
2013-05
Completion
2014-10

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator ARTENIMOL Small molecule 2.5 mg/kg Oral
Comparator Artemether Small molecule 2 mg/kg Oral
Comparator Artesunate Small molecule 4 mg/kg Oral
Comparator Mefloquine Unknown 8 mg/kg Oral
Comparator lumefantrine Small molecule 10 mg Oral
Comparator piperaquine Small molecule 20 mg/kg Oral
Background Acetaminophen Small molecule 50 mg/kg Oral
Background Amoxicillin Other / unclassified 50 mg/kg —
Background Quinine Small molecule 25 mg/kg —

Indications

Plasmodium falciparum malaria