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Efficacy and Safety of Artemisinin-based Combination Treatments in the Democratic Republic of the Congo

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Disease Information

Descriptive Information
Brief Title † Efficacy and Safety of Artemisinin-based Combination Treatments in the Democratic Republic of the Congo
Official Title † Efficacy and Safety of Artesunate-amodiaquine, Artemether-lumefantrine and Dihydroartemisinine-piperaquine in the Treatment of Uncomplicated Plasmodium Falciparum Malaria in the Democratic Republic of Congo: a Randomized Controlled Trial
Brief Summary The Democratic Republic of the Congo (DRC) is among the countries most affected by malaria in Sub-Saharan Africa. Condidering its size and the geographic position, the DRC is meant to play a major role in the malaria control in the region. The National Malaria Control program recommends artemisinin-based combination treatments (ACTs), in particular artesunate-amodiaquine or artemether-lumefrantrine for the treatment of uncomplicated malaria. Previous studies indicated that ACTs are still effective, with efficacy above the required threshold of 90%. It is required to assess regularly the efficacy of antimalarial drugs, in order to ascertain the relevance of treatment guidelines such that, in case of increasing failure rates, alternative options can be decided ontime. The purpose of this trial is to assess efficacy and safety of artesunate-amodiaquine (ASAQ Winthrop®), artemether-lumefantrine (Coartem Dispersible®) and dihydro-artemisinin-piperaquine (Eurartesim®) at day 42 in the treatment of uncomplicated Plasmodium falciparum malaria in six surveillance sites around DRC.
Detailed Description This is a phase 4, randomized, open labelled clinical trial, aiming to assess efficacy and safety of 3 ACTs in the treatment of uncomplicated malaria in the Democratic Republic of the Congo. Children diagnosed with uncomplicated Plasmodium falciparum uncomplicated malaria will be randomized and followed-up during 42 days.
Study Phase Phase 4
Study Type † Interventional
Study Design †
Primary Outcome Measure † PCR-adjusted efficacy
Secondary Outcome Measure † PCR-unadjusted efficacy
Condition † Malaria
Intervention † Drugartesunate-amodiaquine
Study Arms / Comparison Groups artesunate-amodiaquine Tablets containing 25 mg of artesunate and 67.5 mg of amodiaquine: one tablet daily for three days children weighing 4.5 to 8 kg, and tablets containing 50 mg of artesunate and 135 mg of amodiaquine: one tablet daily for three days for children weighing 9 to 17 kg. artemether-lumefantrine Tablets containing 20 mg of Artemether and 120 mg of Lumefantrine. Each dose to be taken with high-fat food or drinks (for example milk). One tablet twice daily for children weighing 5 to
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 1584
Start Date † March 15, 2017
Completion Date December 31, 2017
Primary Completion Date December 1, 2017
Eligibility Criteria † Inclusion Criteria: - children aged 6 to 59 months - axillary temperature ≥ 37.5 °C or history of fever during the 24 h before recruitment - monoinfection with Plasmodium falciparum with asexual parasite count of 2,000 to 200,000/µL - ability to swallow oral medication - ability and willingness to comply with the protocol for the duration of the study and to comply with the study visit schedule - informed consent from a parent/guardian - absence of general danger signs or signs of severe falciparum malaria according to the definitions of WHO (2000) - absence of severe malnutrition according to WHO child growth standards - absence of febrile condition due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal or hepatic diseases, HIV/AIDS) - absence of regular medication, which might interfere with antimalarial pharmacokinetics - absence of history of hypersensitivity reactions or contraindication to any medicine being tested or used as alternative treatment Exclusion Criteria: - presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of WHO - body weight
Gender All
Ages 6 Months - 59 Months
Accepts Healthy Volunteers No
Contacts †† Gauthier Mesia Kahunu, PhD, +243848428477, mesia.kahunu@unikin.ac.cd
Location Countries † Congo, The Democratic Republic of the
Administrative Information
NCT ID † NCT02940756
Organization ID ASAQ-LA-DHAPQP 2015 DRC
Secondary IDs ††
Responsible Party Principal Investigator
Study Sponsor † Ministry of Public Health, Democratic Republic of the Congo
Collaborators ††
Investigators † Principal Investigator: Gauthier Mesia Kahunu, PhD, University of Kinshasa
Information Provided By
Verification Date April 2017
First Received Date † October 19, 2016
Last Updated Date April 10, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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