Mens 2008 KEN.
Methods | Trial design: An open label RCT Follow‐up: Malaria film and Hb level on days 0, 1, 2, 3, 7, 14, and 28, plus QT‐NASBA for detection of sub‐microscopic gametocytaemia Adverse event monitoring: Adverse events were recorded at each visit in the case record form. An adverse event defined as any unfavourable and unintended sign. |
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Participants | Number of participants: 146 Inclusion criteria: Age 6 months to 12 years, axillary temp > 37.5 °C or history of fever, P. falciparum mono‐infection 1000 to 200,000/µL, informed consent Exclusion criteria: Severe malaria, any other underlying illness |
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Interventions | 1. DHA‐P, fixed dose combination, 20 mg/160 mg tablets (Sigma‐Tau)
2. Artemether‐lumefantrine, fixed dose combination, 20/120 mg tablets (Novartis)
All doses supervised and given with a glass of milk. |
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Outcomes |
Not included in this review:
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Notes | Country: Kenya Setting: Health centre Transmission: High transmission Resistance: Not reported Dates: Apr 2007 to Jul 2007 Funding: The Knowledge and Innovation Fund, Koninklijk Instituut voor de Tropen/Royal Tropical Institute. DHA‐P provided free of charge by Sigma‐Tau. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "A computer generated randomisation list". |
Allocation concealment (selection bias) | Unclear risk | None described. |
Blinding for microscopy outcomes (performance bias and detection bias) | Low risk | Microscopists were blinded to treatment allocation. |
Blinding for adverse events (performance and detection bias) | Unclear risk | No other blinding described. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Low losses to follow‐up in both groups (8.2% DHA‐P versus 8.2% AL6). |
Selective reporting (reporting bias) | Low risk | The WHO recommends 42 days follow‐up in studies of AL6. Day 28 outcomes may underestimate treatment failure with AL6 and DHA‐P. |
Other bias | Low risk | No other sources of bias identified. |