Malaria Therapeutic Efficacy Study, Rwanda
Evaluation of the Efficacy of Artemether-lumefantrine and Dihydroartemisinin-piperaquine in Children With Uncomplicated Clinical Malaria in Rural Rwanda
1 other identifier
interventional
528
1 country
3
Brief Summary
WHO recommends that Therapeutic Efficacy Studies (TES) for 1st and 2nd line antimalarial medicines should be routinely carried out and data made available for decision-making due to the threat of emergence and spread of artemisinin resistance in malaria-endemic countries, especially in Africa. In line with this WHO recommendation, Rwanda Ministry of Health (MOH) is conducting the TES to determine the efficacy of artemether-lumefantrine (ALN), which has been used in Rwanda for the last 14 years) and dihydroartemisinin-piperaquine (DHA-PPQ), another WHO-approved drug for the treatment of uncomplicated malaria which, though, has not been used in Rwanda, is being considered for adoption as a second line or alternative first line treatment. The objective of this study is to inform the decisions or actions made by a public health authority (Rwanda Rwanda Ministry of Health) to inform decision on revision of the antimalarial guidelines and policy in Rwanda. Jhpiego's Impact Malaria project in Rwanda, with funding and technical oversight from US President's Malaria Initiative (PMI) through USAID and CDC, will support the Rwanda MOH in its effort to evaluate the efficacy of ALN and DHA-PPQ in the treatment of children with uncomplicated malaria. The study is being conducted by Rwanda MOH, with technical support and funding by PMI-USAID through Jhpiego in Rwanda.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2021
Typical duration for phase_4
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 11, 2021
CompletedFirst Posted
Study publicly available on registry
February 23, 2021
CompletedStudy Start
First participant enrolled
June 14, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 8, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2024
CompletedFebruary 2, 2024
January 1, 2024
2.5 years
February 11, 2021
January 31, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Number of patients (in the artemether-lumefantrine arm) with clinical and parasitological cure (i.e. free of malaria symptoms and parasites) assessed clinically and via microscopy and rapid diagnostic test
By day 28 post-treatment
Number of patients (in the dihydroartemisinin-piperaquine arm) with clinical and parasitological cure (i.e. free of malaria symptoms and parasites) assessed clinically and via microscopy and rapid diagnostic test
By day 42 post-treatment
Secondary Outcomes (2)
Number of patients (in the artemether-lumefantrine arm) that developed molecular markers of drug (artemisinin) resistance (assessed via phenotype tests)
By day 28 post-treatment
Number of patients (in the dihydroartemisinin-piperaquine arm) that developed molecular markers of drug (artemisinin) resistance (assessed via phenotype tests)
By day 42 post-treatment
Study Arms (2)
artemether-lumefantrine (ALN)
ACTIVE COMPARATORdihydroartemisinin-piperaquine (DHA-PPQ)
ACTIVE COMPARATORInterventions
Assessing the efficacy on current 1st line antimalarial, and an alternative 1st line or 2nd line medicine
dihydroartemisinin-piperaquine (DHA-PPQ)
Eligibility Criteria
You may qualify if:
- Children aged 6 months to 59 months old
- Monoinfection with P. falciparum and parasitaemia of 1,000 - 100,000 asexual parasites per µl
- Axillary temperature 37.5 °C or history of fever in the preceding 24 hours before recruitment
- Ability to swallow oral medication
- Haemoglobin ≥7.0 g/dL at admission
- Informed consent from guardian/parent of patient
- Parent/guardian agrees to bring the patient for planned follow-up visits at day 7, 14, 21, 28, 35, and 42 (35 and 42 in DHA-PPQ arm only)
- Ability for the child to be admitted to a health center for inpatient blood testing, observation and treatment for three days
You may not qualify if:
- Danger signs of severe malaria or signs of severe malaria
- Other underlying diseases (cardiac, renal, hepatic diseases)
- Severe malnutrition according to WHO child growth standards (WHO, 2006), children - with marasmus or oedematous malnutrition
- History of allergy to study drugs
- A clear history of receiving any antimalarial treatment in the preceding 72 hours
- Ongoing prophylaxis with drugs having antimalarial activity, such as cotrimoxazole for the prevention of Pneumocisti jirovici pneumonia in children born to HIV+ women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jhpiegolead
- Ministry of Health, Rwandacollaborator
- Centers for Disease Control and Preventioncollaborator
- United States Agency for International Development (USAID)collaborator
Study Sites (3)
Bugarama health center
Bugarama, Rwanda
Masaka health center
Masaka, Rwanda
Rukara health center
Rukara, Rwanda
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 11, 2021
First Posted
February 23, 2021
Study Start
June 14, 2021
Primary Completion
December 8, 2023
Study Completion
January 31, 2024
Last Updated
February 2, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share