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

Primary Purpose

Malaria

Status
Completed
Phase
Phase 4
Locations
Congo, The Democratic Republic of the
Study Type
Interventional
Intervention
artesunate-amodiaquine
artemether-lumefantrine
Dihydroartemisinine-piperaquine
Sponsored by
Ministry of Public Health, Democratic Republic of the Congo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malaria focused on measuring Malaria, efficacy, safety, ACT, DR Congo

Eligibility Criteria

6 Months - 59 Months (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Centre de santé Bolenge
  • Centre de Santé Lupidi 1
  • Centre de Santé de Référence Mikalayi
  • Centre Evangélique de Coopération
  • Centre de Santé de Référence Rutshuru
  • Centre de Santé Foyer Social

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

artesunate-amodiaquine

artemether-lumefantrine

Dihydroartemisinine-piperaquine

Arm Description

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.

Outcomes

Primary Outcome Measures

PCR-adjusted efficacy
the proportion of children with PCR adequate clinical and parasitological response

Secondary Outcome Measures

PCR-unadjusted efficacy
the proportion of children with treatment failure: all treatment failures detected during the follow-up, regardless of genotyping
K-13 propeller polymorphisms
the proportion of mutations in portions of P. falciparum gene encoding kelch(K-13)-propeller domains (confering resistance to artemisinin)
incidence of adverse events
monitoring of all adverse events experienced by participants

Full Information

First Posted
October 19, 2016
Last Updated
January 2, 2018
Sponsor
Ministry of Public Health, Democratic Republic of the Congo
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1. Study Identification

Unique Protocol Identification Number
NCT02940756
Brief Title
Efficacy and Safety of Artemisinin-based Combination Treatments in the Democratic Republic of the Congo
Acronym
TETRDC2016
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
March 15, 2017 (Actual)
Primary Completion Date
January 2, 2018 (Actual)
Study Completion Date
January 2, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ministry of Public Health, Democratic Republic of the Congo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria
Keywords
Malaria, efficacy, safety, ACT, DR Congo

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1615 (Actual)

8. Arms, Groups, and Interventions

Arm Title
artesunate-amodiaquine
Arm Type
Experimental
Arm Description
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.
Arm Title
artemether-lumefantrine
Arm Type
Experimental
Arm Description
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.
Arm Title
Dihydroartemisinine-piperaquine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
artesunate-amodiaquine
Other Intervention Name(s)
artesunate-amodiaquine Winthrop®
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
artemether-lumefantrine
Other Intervention Name(s)
Coartem®
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Dihydroartemisinine-piperaquine
Other Intervention Name(s)
Eurartesim®
Intervention Description
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.
Primary Outcome Measure Information:
Title
PCR-adjusted efficacy
Description
the proportion of children with PCR adequate clinical and parasitological response
Time Frame
day 42
Secondary Outcome Measure Information:
Title
PCR-unadjusted efficacy
Description
the proportion of children with treatment failure: all treatment failures detected during the follow-up, regardless of genotyping
Time Frame
day 42
Title
K-13 propeller polymorphisms
Description
the proportion of mutations in portions of P. falciparum gene encoding kelch(K-13)-propeller domains (confering resistance to artemisinin)
Time Frame
day 42
Title
incidence of adverse events
Description
monitoring of all adverse events experienced by participants
Time Frame
day 42

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
No
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 < 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gauthier Mesia Kahunu, PhD
Organizational Affiliation
University of Kinshasa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre de santé Bolenge
City
Bolenge
State/Province
Equateur
Country
Congo, The Democratic Republic of the
Facility Name
Centre de Santé Lupidi 1
City
Kapolowe
State/Province
Haut-Katanga
Country
Congo, The Democratic Republic of the
Facility Name
Centre de Santé de Référence Mikalayi
City
Kazumba
State/Province
Kasai Central
Country
Congo, The Democratic Republic of the
Facility Name
Centre Evangélique de Coopération
City
Kimpese
State/Province
Kongo Central
Country
Congo, The Democratic Republic of the
Facility Name
Centre de Santé de Référence Rutshuru
City
Rutshuru
State/Province
Nord-Kivu
Country
Congo, The Democratic Republic of the
Facility Name
Centre de Santé Foyer Social
City
Kabondo
State/Province
Tshopo
Country
Congo, The Democratic Republic of the

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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