Methods |
Individually RCT Dates of trial: Randomization June 2004; trial done 17 August 2004 to 3 September 2004. |
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Participants |
104 people with asymptomatic P. falciparum positive by slide and positive for gametocytes by PCR. No information given on age and sex. Site: Two villages in East Sudan where there is seasonal malaria, mainly P. falciparum, during October to December. Exclusion criteria: Pregnancy, history of sulfa allergy, fever or other symptoms, Plasmodium spp other than P. falciparum present. |
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Interventions |
1. AS: Children < 50 kg: 4 mg/kg; All = 50 kg: 200 mg (two 100 mg tabs) days 1, 2, and 3 (reported as days 0, 1, and 2). SP: Children < 50 kg: 25 mg/kg S + 1.25 mg/kg P; All = 50 kg: 3 tablets of 500 mg S + 25 mg P. 2. As for 1. above plus PQ 0.75 mg/kg day 4 (reported as day 3). |
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Outcomes |
1. Proportion of people with P. falciparum parasites by PCR days 4, 8 and 15 (reported as days 3, 7 and 14) 2. Proportion of people with gametocytes by RT-PCR days 8 and 15 (reported as days 7 and 14) 3. Adverse events days 2, 3, 4, 8 and 15 (reported as days 1, 2, 3, 7 and 14) 4. Packed cell volume days 1, 8 and 15 (reported as days 0, 7 and 14) |
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Notes |
The trial was conducted about two months after the initial screening for positives (asymptomatic carriers). |
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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 |
"The list of carriers was sorted according to village and age to ensure that the treatment groups were balanced with respect to these two variables. The random allocation of this ordered list into the treatment arms was then created using restricted randomization with a block size of 12 in STATA v7" |
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Allocation concealment (selection bias) |
Unclear risk |
No information given. |
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Incomplete outcome data (attrition bias) All outcomes |
Low risk |
Only three of 104 participants did not complete follow-up. |
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Selective reporting (reporting bias) |
Low risk |
No obvious selective reporting. |
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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 |
High risk |
Patients and health staff were not blinded. |
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Blinding of outcome assessment (detection bias) All outcomes |
Low risk |
Lab staff doing PCR were blinded. |