Malaria Infections and Infestations Malaria
Conditions
Interventions
The patients will be randomised to either quinine or another ACT regimen:
1. AL to quinine or DP
2. Chlorproguanil hydrochloride-dapsone-artesunate [CDA] to quinine
3. AL or DP
4. DP to quinine or AL
Sponsors
Uganda Malaria Surveillance Project (Uganda)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females aged between 1 and 5 years inclusive 2. Recurrent Plasmodium falciparum infection after treatment with ACTs in a related main study 3. Parents' or guardians? willingness and ability to comply with the study protocol for the duration of the trial
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to the study drugs 2. Severe malaria 3. Danger signs: 3.1. Not able to drink or breast-feed 3.2. Vomiting (greater than twice in 24 hours) 3.3. Recent history of convulsions (greater than 1 in 24 hours) 3.4. Unconscious state 3.5. Unable to sit or stand 4. Early treatment failure in the main study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Polymerase chain reaction (PCR) unadjusted treatment failure up to day 28 2. PCR adjusted treatment failure up to day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Fever clearance time 2. Asexual parasite clearance time 3. Gametocytaemia (prevalence and density) at day 7, 14, 21 and 28 after treatment 4. Haemoglobin (Hb) changes day 28 or day of treatment failure 5. Change in the frequency of plasmodial genetic polymorphisms (pfmdr1) as longitudinal markers of antimalarial drug resistance 6. Safety profiles including significant changes in relevant laboratory values | — |
Countries
Uganda
Outcome results
None listed