|
NAVRONGO HEALTH RESEARCH CENTRE A Field station of the Ministry of Health, Ghana (Member of the INDEPTH Network)
|
||||||||||
Location
:Kassena-Nankana District of Northern Ghana (Ghana arm
of a multicenter study.
Other sites in Tanzania and Bangladesh)
Study Director :Dr. Melba Gomes (WHO-TDR)
Investigators :Dr. John Gyapong (Health Research Unit - Ghana)
On-site investigators: Dr Christine Clerk, Dr. Frank Baiden
Collaboration :Ministry of Health, Ghana, UNDP/World Bank/WHO-TDR
Funding :
Period Covered:2000-3
Status : On-going
Malaria continues to be a major cause of morbidity and mortality in malaria endemic countries in the world. It is estimated to account for 23% of child deaths in the Kassena-Nankana district in northern Ghana. Although there are efficacious drugs to treat malaria, many children who develop severe disease die before they can receive any help. Death from cerebral malaria usually occurs within 24-48 hours after admission and mortality from severe malaria is estimated between 10-40% depending on the facilities available for its management, and the time treatment is started.
It is therefore critical to start treatment very early, in order to stop the progression of the disease to its severe form. However, in most endemic countries, transportation is unavailable, patients have to travel long distances to reach health facilities. Parenteral drugs cannot be administered except in health facilities and a majority of these children are unable to take oral drugs and hence die before they can reach these health facilities. The few patients who make it to the health facilities get there too late, and die shortly after treatment has started.
Artemisinin and its derivatives have recently been the focus of scientific study although they have been used as folk medicine for centuries. They have been found to contain the most powerful antimalarial compounds yet known and effective in the treatment of severe and multi-drug resistant P. falciparum malaria. The efficacy of the suppository formulation of artemisinin and artesunate have been tested in several clinical trials and found to be effective in the treatment of complicated and uncomplicated malaria and compare favourably with the traditional drugs such as quinine. The suppository formulation has also been shown to be as effective as parenteral formulations of artemisinin compounds and with intra-venous quinine. Artemisinin and derivatives have been found to be well tolerated and there is no evidence of neurotoxicity, cardiotoxicity, skin reactions or allergies in man in the several human trials so far carried out, although neurotoxicity has been documented in animals.
For the majority of children in malaria endemic countries, the development of these antimalarials which can be given rectally, providing a good concentration of the antimalarial in the blood even at home, would be very critical in saving several lives, especially, where it is not possible to take oral medication and facilities for parenteral administration are not readily available. The benefits from lives saved, avoidance of severe disease and a reduction in acute caseload at district hospitals would be of great public health importance.
The study objective is establish whether there is a survival benefit in treating non per os (NPO) malaria patients with rectal artesunate prior to referral to a hospital, and specifically, to evaluate the benefit of a single dose of rectal artesunate (AS) given to (NPO) malaria patients age 6-71 months prior to referral to hospital, in reducing the number of deaths and the number of individuals with severe neurological disability. The study will also evaluate the impact of the intervention on the time it takes for the NPO malaria to resolve, and the effect the type of treatment given at the hospital has on the outcome of the illness in addition to the intervention.
STUDY DESIGN: Double-blind randomized controlled trial
Person to whom correspondence should be addressed:
Dr. John Gyapong
Health Research Unit.
Ministry of Health
PO Box 184 Accra Ghana,
Phone: +233 21 230 220, Fax: +233 21 226 739