Impact of Artemisinin-based Combination Therapy and Quinine on Treatment Failure and Resistance in Uncomplicated Malaria
Status:
Completed
Trial end date:
2014-06-01
Target enrollment:
Participant gender:
Summary
This is a bi-centric phase IIIb, randomized, open label, 3-arm clinical trial performed to
investigate the impact of retreatment with an Artemisinin-Based Combination (ACT), for
example Arthemeter-Lumefantrine (AL) in Uganda (Ug) and artesunate-amodiaquine (ASAQ) in
RDCongo, on malaria incidence and its potential selection of resistant strains.
Patients will be followed-up for efficacy and safety during 42 days after treatment with the
first line therapy recommended by the national authorities(arthemeter-lumefantrine in Uganda
and artesunate-amodiaquine in RDCongo) and retreated the patients either with the same ACT or
an other ACT or oral Quinine + clyndamicin.
The investigators hypothesize that (re)treatment with the first line ACT treatment beyond 14
days is as efficacious as any other rescue treatment, without the risk of selecting drug
resistant strains.
Phase:
Phase 3
Details
Lead Sponsor:
Universiteit Antwerpen
Collaborators:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Centre Muraz European and Developing Countries Clinical Trials Partnership (EDCTP) Fund for Scientific Research, Flanders, Belgium Institute of Tropical Medicine, Belgium Makerere University University of Kinshasa