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 from 6 months up to the age of 71 months old 3. Clinical diagnosis of probable P. falciparum malaria based on history from the parent/guardian and assessment of the Field Worker 4. Presence of one or more of the following conditions: 4.1. Repeated vomiting (defined as more than three episodes immediately after feeding in the previous 24 hours) 4.2. Inability to eat, drink or suck 4.3. Recurrent convulsions (defined as at least two fits in the previous 24 hours) 4.4. Altered consciousness (obtunded response to painful stimuli, coma, altered behaviour) 4.5. So weak that cannot sit/stand/walk unaided and so cannot take oral medication 5. Consent by patient or parent/guardian (if patient younger than 18) 6. 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
Ghana
Outcome results
None listed