Test Efficacy Study on the Recommended Antimalarial Drugs in the Democratic Republic of the Congo

NCT06076213 | Completed Phase 4

• 1 other identifier: ASAQ-AL 2022
• Study Type: interventional
• Target: 1,260
• Locations: 1 country
• Sites: 7

Brief Summary

Malaria remains a public health concern, despite efforts that are invested in the disease control. The Democratic Republic of the Congo (DRC) is one of the most affected countries in Sub Saharan Africa. Artemisinin-based combination treatments (ACTs) are recommended for the treatment of uncomplicated malaria. However, reported cases of mutations that confer to Plasmodium falciparum resistance to artemisinin (the main component of ACTs) constitute a threat to malaria control, particularly in Sub Saharan Africa. Therefore, the recommendation of the World Health Organization to conduct regularly test efficacy studies in endemic countries is paramount. The purpose of this trial is to assess efficacy and safety of artesunate-amodiaquine (ASAQ Winthrop®) and artemether-lumefantrine (Coartem Dispersible®) at day 28 for the treatment of uncomplicated Plasmodium falciparum malaria in eight surveillance sites around DRC.

Conditions

Uncomplicated Plasmodium Falciparum Malaria

Keywords

Uncomplicated malaria; Plasmodium falciparum; Artemisinin-based Combination Treatment; Artemether-lumefantrine; Artesunate-amodiaquine

Outcome Measures

Primary Outcomes (1)

• PCR adjusted efficacy

  Absence of fever and negative blood smear during the follow-up until day 28 or new infection occurred during the follow-up.

  day 28

Secondary Outcomes (4)

• Proportion of adverse events and serious adverse events

  day 28

• Prevalence of HRP2 deletion

  Baseline

• Prevalence of resistance markers at baseline

  Baseline

• Quantification of Lumefantrine

  day 7

Study Arms (2)

Artesunate-amodiaquine

EXPERIMENTAL

tablets of ASAQ Winthrop®

Drug: Artesunate-amodiaquine

Artemether-lumefantrine

EXPERIMENTAL

tablets of Coartem Dispersible®

Drug: Artemether-lumefantrine

Interventions

Artesunate-amodiaquine DRUG

Tablets

Also known as: ASAQ Winthrop®

Artesunate-amodiaquine

Artemether-lumefantrine DRUG

Tablets

Also known as: Coartem Dispersible®

Artemether-lumefantrine

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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 a guardian
• living within the study catchment area
• absence of severe manutrition
• absence of infectious diseases that can be responsible of fever
• absence of allergy to the study drugs

You may not qualify if:

• presence of general danger signs 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;
• body weight below 5 kg

Sponsors & Collaborators

• Ministry of Public Health, Democratic Republic of the Congo: lead
• Centers for Disease Control and Prevention: collaborator
• Global Fund: collaborator

Study Sites (7)

Centre de santé de Coopération

Kimpese, Bas-Congo Province, Democratic Republic of the Congo

Location

Centre de santé Lupidi 1

Kapolowe, Haut-Katanga, Democratic Republic of the Congo

Location

Centres de santé de Mikalayi et Matamba

Kazumba, Kasai-Central, Democratic Republic of the Congo

Location

Centre de Santé de Vanga

Vanga, Kwilu, Democratic Republic of the Congo

Location

Centre de santé de Kalima

Kalima, Maniema Province, Democratic Republic of the Congo

Location

Centres de santé Umoja et Foyer social

Kabondo, Tshopo, Democratic Republic of the Congo

Location

Centre de santé Boende 2 Nsele

Boende, Tshuapa, Democratic Republic of the Congo

Location

MeSH Terms

Conditions

Malaria, Falciparum

Interventions

amodiaquine, artesunate drug combination; Artemether, Lumefantrine Drug Combination

Condition Hierarchy (Ancestors)

Malaria; Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Artemether; Artemisinins; Reactive Oxygen Species; Free Radicals; Inorganic Chemicals; Organic Chemicals; Lumefantrine; Fluorenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sesquiterpenes; Terpenes; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomization 1:1 in two treatment arms: artesunate-amodiaquine and artemether-lumefantrine

Study Record Dates

• First Submitted: September 24, 2023
• First Posted: October 10, 2023
• Study Start: May 1, 2023
• Primary Completion: September 24, 2024
• Study Completion: September 30, 2024
• Last Updated: November 5, 2024

Record last verified: 2024-11

Locations

DE (7)