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Efficacy and Safety of Artemisinin-based Combination Treatments in the Democratic Republic of the Congo (TETRDC2016)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02940756
Recruitment Status : Completed
First Posted : October 21, 2016
Last Update Posted : January 3, 2018
Sponsor:
Information provided by (Responsible Party):
Prof. Gauthier Mesia Kahunu, Ministry of Public Health, Democratic Republic of the Congo

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.


Condition or disease Intervention/treatment Phase
Malaria Drug: artesunate-amodiaquine Drug: artemether-lumefantrine Drug: Dihydroartemisinine-piperaquine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1615 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 15, 2017
Actual Primary Completion Date : January 2, 2018
Actual Study Completion Date : January 2, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
Experimental: 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.
Drug: 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.
Other Name: artesunate-amodiaquine Winthrop®

Experimental: 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 <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.

Drug: 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 <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.

Other Name: Coartem®

Experimental: Dihydroartemisinine-piperaquine
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.
Drug: Dihydroartemisinine-piperaquine
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.
Other Name: Eurartesim®




Primary Outcome Measures :
  1. PCR-adjusted efficacy [ Time Frame: day 42 ]
    the proportion of children with PCR adequate clinical and parasitological response


Secondary Outcome Measures :
  1. PCR-unadjusted efficacy [ Time Frame: day 42 ]
    the proportion of children with treatment failure: all treatment failures detected during the follow-up, regardless of genotyping

  2. K-13 propeller polymorphisms [ Time Frame: day 42 ]
    the proportion of mutations in portions of P. falciparum gene encoding kelch(K-13)-propeller domains (confering resistance to artemisinin)

  3. incidence of adverse events [ Time Frame: day 42 ]
    monitoring of all adverse events experienced by participants



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 < 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02940756


Locations
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Congo, The Democratic Republic of the
Centre de santé Bolenge
Bolenge, Equateur, Congo, The Democratic Republic of the
Centre de Santé Lupidi 1
Kapolowe, Haut-Katanga, Congo, The Democratic Republic of the
Centre de Santé de Référence Mikalayi
Kazumba, Kasai Central, Congo, The Democratic Republic of the
Centre Evangélique de Coopération
Kimpese, Kongo Central, Congo, The Democratic Republic of the
Centre de Santé de Référence Rutshuru
Rutshuru, Nord-Kivu, Congo, The Democratic Republic of the
Centre de Santé Foyer Social
Kabondo, Tshopo, Congo, The Democratic Republic of the
Sponsors and Collaborators
Ministry of Public Health, Democratic Republic of the Congo
Investigators
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Principal Investigator: Gauthier Mesia Kahunu, PhD University of Kinshasa

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Responsible Party: Prof. Gauthier Mesia Kahunu, Professor, Ministry of Public Health, Democratic Republic of the Congo
ClinicalTrials.gov Identifier: NCT02940756     History of Changes
Other Study ID Numbers: ASAQ-LA-DHAPQP 2015 DRC
First Posted: October 21, 2016    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Prof. Gauthier Mesia Kahunu, Ministry of Public Health, Democratic Republic of the Congo:
Malaria, efficacy, safety, ACT, DR Congo

Additional relevant MeSH terms:
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Malaria
Protozoan Infections
Parasitic Diseases
Artesunate
Lumefantrine
Artemether
Piperaquine
Amodiaquine
Artemether, Lumefantrine Drug Combination
Dihydroartemisinin
Artemisinins
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics