Impact of early administration of artesunate suppository on childhood severe malaria in Tanzania

INTERVENTION: The sample size determination in the protocol specified that a total of 10,000 non per os patients would need to be randomised in order to detect a reduction of mortality from 5% to 3%. Individual patients will be randomised to receive either AS suppository (intervention group) or placebo (comparator group). Patients in both groups will then be referred immediately to the nearest hospital/health centre. CONDITION: Malaria ; Infections and Infestations ; Malaria PRIMARY OUTCOME: 1. Number of relevant deaths in the intervention and control arm assessed 7 ‐ 30 days after enrolment (relevant defined as malaria positive patients in whom the death was probably/definitely preventable by the intervention); 2. Number of individuals with serious neurological disability in the intervention and control arms assessed at 7 ‐ 30 days following enrolment in the study. Neurological disability defined as the development of new problems with feeding, walking, talking, sitting, sight, hearing, playing, balance and behaviour SECONDARY OUTCOME: 1. Number of deaths in the intervention and control arm assessed 7 ‐ 30 days following enrolment in the study; 2. Number of cases of neurological disability in the intervention and control arms assessed at 7 ‐ 30 days following enrolment in the study; 3. Number of cases of neurological disability in malaria smear positive patients in the intervention and control arms assessed at 7 ‐ 30 days following enrolment in the study; 4. Number of cases of neurological disability in children in the intervention and control arms assessed at 7 ‐ 30 days following enrolment in the study; 5. Number of cases of neurological disability in pregnant women in the intervention and control arms assessed at 7 ‐ 30 days following enrolment in the study; 6. Number of deaths and neurological sequelae in the intervention and control arm in malaria smear positive patients who survived at least 8 hours but died before 7 days after enrolment in the study INCLUSION CRITERIA: 1. Non per os children presenting to a peripheral health unit or traditional healer with clinicallly suspected P. falciparum malaria 2. Children (apparent age 6 months to 71 months) with suspected malaria who are too ill to take drugs by mouth 3. Individual informed consent ‐ consent must have been given (generally by thumb‐print) by the patient or guardian of the sick person 4. Community informed consent ‐ at the start of the study in that area, community consent to the project would have been obtained