Study 13: Introduction
A study to determine the role and benefit of rectal artesunate for this indication was undertaken in children and older patients in malaria-endemic rural areas of Bangladesh, Ghana and the United Republic of Tanzania. Patients with suspected malaria who could not take oral drugs, and would take several hours to access injectable treatment at a clinic, received either one artesunate or one placebo suppository, and were referred to the nearest clinic for follow-up.
Study 13 is the largest individually randomised clinical trial on severe malaria. It is one of a number of research projects funded by TDR on artesunate, spanning basic chemistry through to clinical trials. The research has underpinned the development of rectal artesunate for use as a single-dose pre-referral treatment for patients who are otherwise headed for death from malaria because they have no alternative therapy when they can no longer take oral medication in their community.
TDR developed the indication and a regulatory plan to enable patients to have a reliable, practical alternative for initial management severe malaria as close to their home as possible. Rectal artesunate is intended to be administered easily at a village or rural health centre level, and to "buy" valuable time while the sick patient is being transferred to a hospital, health centre or clinic for definitive treatment. The aim of this development has been to help realize WHO’s objective of reducing malaria mortality significantly, particularly in African children who carry the vast burden of this disease.
This large randomized placebo-controlled community-based study was undertaken in Bangladesh, Ghana and the United Republic of Tanzania. The results of study 13 which took two years to prepare, six years to implement and two years to analyse were reported in the 14 February, 2009 issue of The Lancet. In addition to providing scientific information on patients where there was little or no information, the activities have supported the development and strengthening of research sites in the African and Asian countries involved in this study.