Clinical Trials Logo

Clinical Trial Summary

Following the rapid development of significant drug resistance to both chloroquine and sulfadoxine-pyrimethamine (the first line therapy in Tanzania from 2001 -2006), artemether- lumefantrine (Coartem or AL) was adopted as first line therapy in Tanzania in 2006. Now that this drug has been widely used for some time, the investigators propose to conduct an antimalarial efficacy trial to monitor the effectiveness of this therapy, to determine if this drug remains efficacious, or if significant resistance has emerged, in which case a new antimalarial strategy will need to be contemplated. The investigators hypothesize that the efficacy of Artemether-lumefantrine remains high, and that the other artemisinin combination therapies will be equally efficacious.

Children 6-59 months of age with symptomatic malaria will be randomly assigned to be treated with either artemether + lumefantrine (Coartem) or dihydroartemisinin-piperaquine (Duo-Cotecxin or Artekin). Clinical, parasitologic, and hematologic parameters will be monitored over a 42-day follow-up period and will be used to evaluate drug efficacy.


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01082705
Study type Interventional
Source Centers for Disease Control and Prevention
Contact
Status Completed
Phase Phase 3
Start date April 2010
Completion date June 2011

See also
  Status Clinical Trial Phase
Completed NCT04877626 - Assessment of the Therapeutic Efficacy and Tolerability of the Artesunate/Amodiaquina Combination and Artemether/Lumefantrine Combination, Treatment of Uncomplicated P. Falciparum Malaria in the Department of Chocó (Colombia) Phase 4
Completed NCT00757887 - Re-exposure of EHMI-8 Human Volunteers to Live Malaria Sporozoites N/A
Terminated NCT01640587 - Compare the Effectiveness Between Existing Treatment and New Treatment N/A
Completed NCT02427360 - Evaluating the Efficacy of Artesunate-mefloquine and the Relative Roles of Resistance Genetic Markers