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. Children above crawling age and adults of any age group 2. Clinical diagnosis of probable P. falciparum malaria (fever, or history of fever without any other obvious cause of fever). Clinical features must include fever or history of fever and at least one of the following: 2.1. Unable to take food, drink or suck 2.2. Prostration: inability to sit, stand or walk unaided 2.3. Any abnormal level of consciousness i.e. from abnormal behavior, obtunded (limited response to painful stimulus), to coma (unconsciousness with absent verbal response and non-specific or absent motor response) 2.4. Fits or history of fits (defined as more than one fit in the previous 24 hours) 3. Consent by patient or parent/guardian if patient is less than 18 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: 1. Afebrile (history/examination) 2. Unwillingness to sign (or parental signature) informed consent for study participation 3. Ability to take oral medication 4. Diarrhoea (at least two loose bowel movements in the previous two hours) N.B. Pregnant or breast-feeding women will not be excluded from the study. Status of pregnancy in female will be noted in the Case Record Form (CRF).
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
Bangladesh
Outcome results
None listed