DeTACT-Asia

Funder
UKAid, Foreign & Commonwealth Development Office

Principal Investigators
Professor A.M. Dondorp
Dr Erni Juwita Nelwan

Locations
Bangladesh
Cambodia
Jayapura City, Indonesia

Duration
June 2021 – March 2023

Trial Registration

A multi-centre randomised controlled non-inferiority trial to compare the efficacy, safety and tolerability of Triple Artemisinin-based Combination Therapies versus first-line ACTs + placebo for the treatment of uncomplicated Plasmodium falciparum malaria in Asia.

Background

Loss of efficacy of first-line Artemisinin combination therapies (ACTs) jeopardises current malaria control and elimination efforts and will accelerate the spread of drug resistance. New antimalarial drugs are not expected to come to the market within the next five years.

There is an urgent need to evaluate alternative treatments using combinations of existing drugs which will not fall rapidly to resistance and can be deployed immediately. The deployment of Triple Artemisinin Combination Treatments (TACT) could be part of such a strategy.

Aims

This project aims to compare the efficacy, safety and tolerability of the TACTs artemether-lumefantrine+amodiaquine and artesunate-mefloquine+piperaquine and the standard ACTs artemether-lumefantrine+placebo, and artesunate-mefloquine+placebo.

From left to right: OUCRU ID Clinical Trial Coordinator, OUCRU ID Laboratory and Field Support, OUCRU ID Clinical Trial Laboratory Manager, Co-Investigator, Director of RSUD Ramela Muara Tami, Indonesia Site PI

Outputs to date

In Indonesia, recruitment has not started yet. The trial documents are currently under submission to the Indonesian FDA and have been approved by The Ethics Committee of the Faculty of Medicine, University of Indonesia – Cipto Mangunkusumo Hospital on August 12th, 2022.

We anticipate fully enrolling this site with 235 P. falciparum patient subjects commencing in December 2022 before May 2023.

 

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