Start of Phase II trial of intravenous artesunate for children with severe malaria

Aug 30 2007

A multicentre Phase II trial of intravenous artesunate will begin recruitment of patients in September.

The €5.3 M trial, funded by the European and Developing Countries Clinical Trials Partnership (EDCTP), and sponsored by Medicines for Malaria Venture (MMV) will be conducted in Gabon and Malawi. It will evaluate the efficacy of two intravenous artesunate dosing regimens in clearing Plasmodium falciparum parasites in children with severe malaria. The trial protocol has been approved by the ethics committees and national regulatory authorities in Malawi and Gabon.

Severe malaria kills more than one million African children each year. Antimalarial chemotherapy is the mainstay of treatment. In Africa, intravenous quinine is currently used to treat children with severe malaria but it is poorly tolerated and has several side effects. In some south-east Asian countries, artemisinin-based treatments are already used in preference to quinine. Intravenous artesunate is now recommended by the World Health Organization for the treatment of severe malaria in adults in low transmission areas, but there is little information on its efficacy in children in high transmission regions, such as Africa.

This phase II randomised, double-blind, dose-finding study of the efficacy, safety, tolerability and pharmacokinetics of intravenous artesunate in African children with severe malaria has two main objectives:

1. To increase the body of evidence for the use of this drug in children in high transmission areas and show that the use of the potentially more toxic intravenous quinine can be avoided

2. To simplify the dosing regimen of intravenous Artesunate from 5 to 3 injections.

On occasion of the start of the trial, Prof. Charles Mgone, EDCTP Executive Director said: "The most rational and effective way to combat a serious problem such as malaria in Africa is to combine all available resources. Working in collaboration with MMV, EDCTP is supporting this partnership of European and African scientists to find a safe, affordable and accessible treatment for malaria in children"

“If we can show superior efficacy and/or safety and tolerability of the new artesunate regimen in African children, we are likely to see a major policy change in the treatment of severe malaria in African children,” said Dr. J Carl Craft, Chief Scientific officer of MMV. “I.V. artesunate has the potential to save countless young lives.”