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Safety and Efficacy of Recommended Antimalarial in the Democratic Republic of the Congo (TET2020)

Primary Purpose

Malaria

Status
Completed
Phase
Phase 4
Locations
Congo, The Democratic Republic of the
Study Type
Interventional
Intervention
Artesunate-amodiaquine
Artemether-lumefantrine
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

Eligibility Criteria

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

Inclusion Criteria:

  • children aged 6 to 59 months
  • monoinfection with Plasmodium falciparum with asexual parasite count of 2,000 to 200,000/µL
  • axillary temperature ≥ 37.5 °C
  • 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 or aguardian
  • living within the study catchment area

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 or hematocrit < 15%
  • 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;
  • malaria treatment within 2 days prior to recruitment
  • history of hypersensitivity reactions or contraindications to any of the medicines being tested or used as alternative treatment

Sites / Locations

  • 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
  • Centre de Santé Boende 2 Nsele

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Artesunate-amodiaquine

Artemether-lumefantrine

Arm Description

Tablets containing 25 mg of artesunate and 67.5 mg of amodiaquine: one tablet daily for three days for 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.

Outcomes

Primary Outcome Measures

PCR adjusted efficacy
absence of fever and negative blood smear during the follow-up until day 28 and new infections occurred during the follow-up.

Secondary Outcome Measures

Proportion of adverse events and serious adverse events
Number of adverse events and serious adverse events that every participant will experience
Proportion of participants with positive blood smear at day 3
Number of participants who will still have parasites on day 3

Full Information

First Posted
October 22, 2020
Last Updated
February 8, 2022
Sponsor
Ministry of Public Health, Democratic Republic of the Congo
Collaborators
University of Kinshasa, World Health Organization, Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo
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1. Study Identification

Unique Protocol Identification Number
NCT04618523
Brief Title
Safety and Efficacy of Recommended Antimalarial in the Democratic Republic of the Congo
Acronym
TET2020
Official Title
Efficacy and Safety of Artesunate-amodiaquine and Artemether-lumefantrine in the Treatment of Uncomplicated Plasmodium Falciparum Malaria in the Democratic Republic of the Congo: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
October 26, 2020 (Actual)
Primary Completion Date
February 8, 2022 (Actual)
Study Completion Date
February 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ministry of Public Health, Democratic Republic of the Congo
Collaborators
University of Kinshasa, World Health Organization, Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du 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
Despite all efforts, malaria remains a public health concern, in particular in the Democratic Republic of the Congo (DRC). 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. I 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®) and artemether-lumefantrine (Coartem Dispersible®) at day 28 in the treatment of uncomplicated Plasmodium falciparum malaria in six surveillance sites around DRC.
Detailed Description
This is a phase IV, randomized, open label, 2-arm trial. It will be performed in six malaria sentinel site around the Democratic Republic of the Congo. Children aged 6 to 59 months with confirmed Plasmodium falciparum uncomplicated malaria will be enrolled after informed consent granted by a parent or guardian. They will be randomized to receive either artesunate-amodiaquine or artemether lumefrantrine during 3 days (directly observed treatment) and then followed up until day 28. At each visit, clinical examination will be done and malaria testing as well. Hemoglobin level will be measured on recruitment day and then every two weeks until day 28.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1117 (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 for 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.
Intervention Type
Drug
Intervention Name(s)
Artesunate-amodiaquine
Other Intervention Name(s)
ASAQ Winthrop®
Intervention Description
Artemisinin-based combination treatment
Intervention Type
Drug
Intervention Name(s)
Artemether-lumefantrine
Other Intervention Name(s)
Coartem dispersible®
Intervention Description
Artemisinin-based combination treatment
Primary Outcome Measure Information:
Title
PCR adjusted efficacy
Description
absence of fever and negative blood smear during the follow-up until day 28 and new infections occurred during the follow-up.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Proportion of adverse events and serious adverse events
Description
Number of adverse events and serious adverse events that every participant will experience
Time Frame
28 days
Title
Proportion of participants with positive blood smear at day 3
Description
Number of participants who will still have parasites on day 3
Time Frame
3 days
Other Pre-specified Outcome Measures:
Title
Presence of Plasmodium falciparum resistance markers and deletion of HRP2
Description
Resistance markers and deletion of HRP2 will be assessed
Time Frame
28 days

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 monoinfection with Plasmodium falciparum with asexual parasite count of 2,000 to 200,000/µL axillary temperature ≥ 37.5 °C 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 or aguardian living within the study catchment area 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 or hematocrit < 15% 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; malaria treatment within 2 days prior to recruitment history of hypersensitivity reactions or contraindications to any of the medicines being tested or used as alternative treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gauthier Mesia Kahunu, PhD
Organizational Affiliation
Université de Kinshasa
Official's Role
Principal Investigator
Facility Information:
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
Kisangani
State/Province
Tshopo
Country
Congo, The Democratic Republic of the
Facility Name
Centre de Santé Boende 2 Nsele
City
Boende
State/Province
Tshuapa
Country
Congo, The Democratic Republic of the

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Safety and Efficacy of Recommended Antimalarial in the Democratic Republic of the Congo

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