Pre-referral rectal artesunate to prevent death and disability in severe malaria in Bangladesh, Ghana and United Republic of Tanzania (Study 13, a placebo-controlled trial)
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.
Learn more about Study 13
- Study 13: Introduction
- Study 13: Hypothesis
- Study 13: Site choice
- Study 13: Implementation
- Study 13: Collaborating partners
Controlled rectal artesunate deployment study in Guinea-Bissau, Ghana, Uganda and the United Republic of Tanzania (Study 18)
Alternative methods of delivery of rectal artesunate in remote areas are being studied in 4 African countries. Each site was randomly assigned a different type of village-based treatment provider (village health workers, mothers, traditional healers and a community-mix of treatment providers) similarly trained to treat, refer, and follow up patients. Treatment access, compliance with referral advice, and treatment has been monitored. Independent monthly surveys of pre-referral episodes in the villages are used to determine coverage.
Efficacy and safety of rectal artesunate in paediatric patients in Ghana and Tanzania (Study 15: a randomized controlled study)
This hospital-based study, currently being carried out in Ghana and the United Republic of Tanzania, assesses whether more than one dose of rectal artesunate is safe and effective for patients who need more than 24 hours to get to a medical facility for an injectable treatment.