MedTrace Logo

Malaria Therapeutic Efficacy Study (TES) Kenya

NCT04767191 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2023-11-01

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, Kenya Ministry of Health (MOH) is conducting the TES to determine the efficacy of artemether lumefantrine (AL), and dihydroartemisinin-piperaquine (DHP), the first and second line treatment of uncomplicated malaria in Kenya. The objective of this study is to inform the decisions or actions made by a public health authority (Kenya Ministry of Health) to inform decision on revision of the antimalarial guidelines and policy in Kenya. Jhpiego's Impact Malaria project in Kenya, with funding and technical oversight from US President's Malaria Initiative (PMI) through USAID and CDC, will support the Kenya MOH in its effort to evaluate the efficacy of AL and DHP in the treatment of children with uncomplicated malaria. The study is being conducted by Kenya MOH, with technical support and funding by PMI-USAID through Jhpiego in Kenya.

Conditions

  • Uncomplicated Malaria

Interventions

DRUG

artemether lumefantrine

The drugs are approved and in use by the Kenya Ministry of Health as the 1st and 2nd line treatment for malaria. The study is to assess the continued efficacy of the two drugs in the treatment of uncomplicated malaria.

DRUG

dihydroartemisinin piperaquine

Antimalarial Combinations

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
2021-03-15
Primary Completion
2022-12-18
Completion
2022-12-18

Countries

  • Kenya

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 NCT04767191 on ClinicalTrials.gov