Sawa 2013 KEN.
Methods | Trial design: RCT Follow‐up: Clinical assessment on days 1, 2, 3, 7, 14, 28, and 42 and any other time when child became ill. Blood smears taken on all follow‐up days except day 1. Adverse event monitoring: Not reported |
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Participants | Number of participants: 298 Inclusion criteria: Microscopically confirmed P. falciparum infection with asexual parasite density of 1,000 to 200,000 parasites/µL, tympanic temperature of ≥ 37.5 °C or history of fever in preceding 24 hrs, age 6 months to 10 years, informed consent Exclusion criteria: Hb level of < 5 g/dL, presence of any other Plasmodium species, presence of other febrile disease, severe malaria, history of adverse events with trial drugs |
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Interventions | 1. DHA‐P, fixed dose combination, 40 mg/320 mg tablets (Duocotexin: Holley Pharm)
2. Artemether‐lumefantrine, fixed dose combination, 20 mg/120 mg tablets (Coartem: Novartis)
All doses were supervised. All participants advised to take each dose with fatty food to facilitate absorption. |
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Outcomes |
Not included in the review:
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Notes | Country: Kenya Setting: Community setting Transmission: Moderate transmission intensity Resistance: None reported Dates: Apr to Jun 2009 Funding: Grants from the European Community’s Seventh Framework Programme and the Bill and Melinda Gates Foundation |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "A randomization list was generated for different age strata (<2 years, 2–5 years, and 5–10 years), using MS Excel". |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment is not reported. |
Blinding for microscopy outcomes (performance bias and detection bias) | Low risk | "Except for those involved in administering medication, all staff members engaged in the trial were blinded to the treatment arm to which each child was assigned". |
Blinding for adverse events (performance and detection bias) | Low risk | All staff blinded were except those administering drugs. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Low number of patients without outcomes in both groups (DHA‐P 7.6%, AL6 5.2%). |
Selective reporting (reporting bias) | Low risk | All WHO outcomes are reported. |
Other bias | Low risk | No other sources of bias identified. |