Methods |
Individually RCT Dates of trial: June to Sept 2006. |
|
Participants |
108 children with fever = 37.5 °C or history of fever in last 48 hours and P. falciparum mono-infection 500 to 100,000/μL. Age three to 15 years. Both sexes. Site: Mynuzi health center, NE Tanzania, a hyperendemic area with rainy seasons in Mar-June and Oct-Dec. Exclusion criteria: Hb < 8, inability to take drugs orally, known hypersensitivity to meds, reported anti-malarial treatment in last two weeks, evidence of chronic disease or acute infection other than malaria, domicile outside trial area, signs of severe malaria, eligible for other malaria studies. |
|
Interventions |
1. AS+SP: AS: 4 mg/kg once daily for 3 days; SP: S 25 mg/kg and P: 1.125 mg/kg 2. AS+SP+PQ: As above for AS and SP plus PQ base 0.75 mg/kg on the third day. |
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Outcomes |
1. Proportion of people with gametocytes (by microscopy) days 1, 4, 8, 15, 29, and 43 (reported as 0, 3, 7, 14, 28, and 42). 2. Proportion with gametocytes (by PCR), same time points. 3. Gametocyte density by PCR. 4. AUC for gametocyte presence. 5. Adverse events. 6. Adequate clinical and parasitological response. 7. Haemoglobin. |
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Notes |
Hb outcome assessed with respect to G6PD variant. |
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Risk of bias |
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Bias |
Authors' judgement |
Support for judgement |
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Random sequence generation (selection bias) |
Low risk |
Generated in STATA 8.0 using restricted randomization with block size of 20. |
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Allocation concealment (selection bias) |
Unclear risk |
Pre-prepared envelopes (but person who opened envelope administered treatment). |
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Incomplete outcome data (attrition bias) All outcomes |
Low risk |
Only 2 out of 108 failed to complete follow-up. |
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Selective reporting (reporting bias) |
Low risk |
No information given. |
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Other bias |
Low risk |
No indication of other bias. |
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Blinding of participants and personnel (performance bias) All outcomes |
Unclear risk |
Trial physician evaluated patients, opened envelopes, and administered treatment. Other staff were blinded. Not clear if participants were blinded. |
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Blinding of outcome assessment (detection bias) All outcomes |
Unclear risk |
Not stated. |