Severe Malaria Infections and Infestations Severe Malaria
Conditions
Interventions
Children are randomised (1:1:1) to compare three doses of azithromycin: 10, 15 and 20 mg/kg (based on weight-bands) taken orally once daily over five days in order to optimize dose and study pharmacok
Sponsors
Imperial College, London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Children aged 6 months to 12 years at admission to hospital with Plasmodium falciparum malaria (on either blood film or ParacheckTM rapid diagnostic test) 2. Axillary temperature >380C or <360C 3. ‘Teule’ severity criteria: any one of the following: prostration; respiratory distress; severe anaemia (haemoglobin<5g/dL) or HIV infection 4. Parents willing/able to provide consent
Exclusion criteria
Exclusion criteria: 1. Major contraindications to azithromycin, eg strong existing clinical diagnosis of QT-prolongation 2. Concomitant use of interacting drugs: drugs that may cause QT-prolongation or drugs that may cause a pharmacokinetic interaction with azithromycin, like strong CYP3A/P-GP inducers and concomitantly administered antacids
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sepsis markers are measured using the c-reactive protein tests using blood samples at baseline to 72 hours (continuous) and microbiological cure (7-day). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mortality is measured using dedicated case report forms at clinical visit or telephone interviews at 48 days and 90 days 2. Length of hospital stay is measured using dedicated case report forms 3. Re-hospitalisation measured using parental interview using case report forms at follow up visits on Day 7, Day 28 and Day 90 4. Adverse events is measured using dedicated serious adverse event forms during hospital admission and follow up visits on Day 7, Day 28 and Day 90 | — |
Countries
Uganda
Outcome results
None listed