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

Malaria Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04618523
• Other study ID #: ASAQ-LA 2019 DRC
• Status: Completed
• Phase: Phase 4
• Start date: October 26, 2020
• Est. completion date: February 8, 2022

Study information

• Verified date: February 2022
• Source: Ministry of Public Health, Democratic Republic of the Congo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1117
• Est. completion date: February 8, 2022
• Est. primary completion date: February 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 59 Months

Eligibility

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

Related Conditions & MeSH terms

• Malaria

Intervention

Drug:
• Artesunate-amodiaquine
Artemisinin-based combination treatment
• Artemether-lumefantrine
Artemisinin-based combination treatment

Locations

Country	Name	City	State
Congo, The Democratic Republic of the	Centre de Santé Boende 2 Nsele	Boende	Tshuapa
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 Foyer Social	Kisangani	Tshopo
Congo, The Democratic Republic of the	Centre de Santé de Référence Rutshuru	Rutshuru	Nord-Kivu

Sponsors (4)

Lead Sponsor	Collaborator
Ministry of Public Health, Democratic Republic of the Congo	Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo, University of Kinshasa, World Health Organization

Country where clinical trial is conducted

Congo, The Democratic Republic of the, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Presence of Plasmodium falciparum resistance markers and deletion of HRP2	Resistance markers and deletion of HRP2 will be assessed	28 days
Primary	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.	28 days
Secondary	Proportion of adverse events and serious adverse events	Number of adverse events and serious adverse events that every participant will experience	28 days
Secondary	Proportion of participants with positive blood smear at day 3	Number of participants who will still have parasites on day 3	3 days