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

NCT ID: NCT02940756

Last Updated: 2018-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1615 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-15
• Study Completion Date: 2018-01-02

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.

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 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

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.

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

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.

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.

Group Type: EXPERIMENTAL

Dihydroartemisinine-piperaquine

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

artesunate-amodiaquine Winthrop®; Coartem®; Eurartesim®

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)

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

Sponsors

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

Kabondo, Tshopo, Democratic Republic of the Congo

Centre de santé Bolenge

Bolenge, Équateur Province, Democratic Republic of the Congo

Countries

Democratic Republic of the Congo

Other Identifiers

ASAQ-LA-DHAPQP 2015 DRC

Identifier Type: -

Identifier Source: org_study_id