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Malaria Therapeutic Efficacy Study, Rwanda

NCT04767217 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 528

Last updated 2024-02-02

No results posted yet for this study

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.

Conditions

  • Uncomplicated Malaria

Interventions

DRUG

artemether-lumefantrine (ALN)

Assessing the efficacy on current 1st line antimalarial, and an alternative 1st line or 2nd line medicine

DRUG

dihydroartemisinin-piperaquine (DHA-PPQ)

dihydroartemisinin-piperaquine (DHA-PPQ)

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-14
Primary Completion
2023-12-08
Completion
2024-01-31

Countries

  • Rwanda

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04767217 on ClinicalTrials.gov