Malaria Infections and Infestations Malaria
Conditions
Sponsors
UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)
Eligibility
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: Ability to take an oral medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Tanzania
Outcome results
None listed