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

NCT ID: NCT04618523

Last Updated: 2022-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1117 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-26
• Study Completion Date: 2022-02-08

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.

Conditions

Malaria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Artesunate-amodiaquine

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.

Group Type: EXPERIMENTAL

Artesunate-amodiaquine

Intervention Type: DRUG

Artemisinin-based combination treatment

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.

Group Type: EXPERIMENTAL

Artemether-lumefantrine

Intervention Type: DRUG

Artemisinin-based combination treatment

Interventions

Artesunate-amodiaquine

Artemisinin-based combination treatment

Intervention Type: DRUG

Artemether-lumefantrine

Artemisinin-based combination treatment

Intervention Type: DRUG

Other Intervention Names

ASAQ Winthrop®; Coartem dispersible®

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 59 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Kinshasa

OTHER

Sponsor Role: collaborator

World Health Organization

OTHER

Sponsor Role: collaborator

Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo

OTHER

Sponsor Role: collaborator

Ministry of Public Health, Democratic Republic of the Congo

OTHER_GOV

Sponsor Role: lead

Responsible Party

Prof. Gauthier Mesia Kahunu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gauthier Mesia Kahunu, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kinshasa

Locations

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

Kisangani, Tshopo, Democratic Republic of the Congo

Centre de Santé Boende 2 Nsele

Boende, Tshuapa, Democratic Republic of the Congo

Countries

Democratic Republic of the Congo

Other Identifiers

ASAQ-LA 2019 DRC

Identifier Type: -

Identifier Source: org_study_id