Uncomplicated malaria Infections and Infestations Malaria
Conditions
Interventions
Four armed, blinded, randomised trial comparing:
1. SP (single oral dose) and placebo
2. SP (single oral dose) and chloroquine (once daily for 3 days)
3. SP (single oral dose) and amodiaquine (once da
Sponsors
University of Liverpool (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age more than or equal to 12 and less than 60 months, either sex 2. Weight more than or equal to 6 kg 3. Pure (on microscopic grounds) P. falciparum parasitaemia of 2000 to 200,000 ul 4. Written consent has been obtained from the parent or legal guardian
Exclusion criteria
Exclusion criteria: 1. Severe malaria 2. Antimalarials in previous week 3. Other comcomitant infection at time of presentation 4. Allergy to sulphonamides 5. Involvement in the study in the previous 12 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. World Health Organization (WHO) treatment response endpoints on days 14, 28 and 42 2. Selection of Dihydrofolate Reductase (DHFR) and Dihydropteroate Synthetase (DHPS) resistance associated genotypes 3. Fever clearance time 4. Parasite clearance time 5. Change in haemoglobin between day zero to 14 6. Gametocyte prevalence on day seven or 14 7. Adverse events clinical and laboratory | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcome measures | — |
Countries
Malawi
Outcome results
None listed