Efficacy and Safety of Artemisinin-based Combination Treatments in the Democratic Republic of the Congo
TETRDC2016
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
1 other identifier
interventional
1,615
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2017
Shorter than P25 for phase_4
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 19, 2016
CompletedFirst Posted
Study publicly available on registry
October 21, 2016
CompletedStudy Start
First participant enrolled
March 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 2, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 2, 2018
CompletedJanuary 3, 2018
November 1, 2017
10 months
October 19, 2016
January 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PCR-adjusted efficacy
the proportion of children with PCR adequate clinical and parasitological response
day 42
Secondary Outcomes (3)
PCR-unadjusted efficacy
day 42
K-13 propeller polymorphisms
day 42
incidence of adverse events
day 42
Study Arms (3)
artesunate-amodiaquine
EXPERIMENTALTablets 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
EXPERIMENTALTablets 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 \<15 kg, two tablets twice daily for those weighing 15 to \<25 kg and three tablets twice daily for those weighing 25 to \< 35 kg, for three days.
Dihydroartemisinine-piperaquine
EXPERIMENTALTablets containing 20 mg of dihydroartemisinine and 160 mg of piperaquine. Half a tablet once daily for children weighing 5 to \<7 kg, one tablet once daily for those weighing 7 to \<13 kg, and two tablets once daily for those weighing 13 to \<24 kg, for three days.
Interventions
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.
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 \<15 kg, two tablets twice daily for those weighing 15 to \<25 kg and three tablets twice daily for those weighing 25 to \< 35 kg, for three days.
Tablets containing 20 mg of dihydroartemisinine and 160 mg of piperaquine. Half a tablet once daily for children weighing 5 to \<7 kg, one tablet once daily for those weighing 7 to \<13 kg, and two tablets once daily for those weighing 13 to \<24 kg, for three days.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 \< 5kg
- hemoglobin level \< 5g/ dL
- mixed or monoinfection with another Plasmodium species detected by microscopy
- presence of severe malnutrition
- presence of febrile conditions 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 and hepatic diseases, HIV/AIDS)
- regular medication, which may interfere with antimalarial pharmacokinetics;
- history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Centre Evangélique de Coopération
Kimpese, Bas-Congo Province, Democratic Republic of the Congo
Centre de Santé Lupidi 1
Kapolowe, Haut-Katanga, Democratic Republic of the Congo
Centre de Santé de Référence Mikalayi
Kazumba, Kasai-Central, Democratic Republic of the Congo
Centre de Santé de Référence Rutshuru
Rutshuru, North Kivu, Democratic Republic of the Congo
Centre de Santé Foyer Social
Kabondo, Tshopo, Democratic Republic of the Congo
Centre de santé Bolenge
Bolenge, Équateur Province, Democratic Republic of the Congo
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gauthier Mesia Kahunu, PhD
University of Kinshasa
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 19, 2016
First Posted
October 21, 2016
Study Start
March 15, 2017
Primary Completion
January 2, 2018
Study Completion
January 2, 2018
Last Updated
January 3, 2018
Record last verified: 2017-11