Agarwal 2013 KEN.
Methods | Trial design: An open label RCT Follow‐up: Followed up for 42 days and asked to return on days 1, 2, 3, 7, 14, 21, 28, 35, and 42 after enrolment or at any day if ill. Clinical assessment and blood smear at each visit. Hb measured on days 0, 7, 14, 28, and 42. Adverse event monitoring: Not reported. "Adverse events investigated and addressed". |
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Participants | Number of participants: 274 Inclusion criteria: Children aged 6 to 59 months with axillary temperature ≥ 37.5 °C or history of fever in preceding 48 hrs, weight ≥ 5.0 kg, parasitaemia, residing within 10 km of Siaya District Hospital, written informed consent. Exclusion criteria: Lethargy, convulsions, persistent vomiting, inability to drink, signs of severe malaria, severe anaemia (Hb < 5 g/dL), known hypersensitivity to trial drugs, presence of chronic medical conditions, treatment with any anti‐malarial in preceding two weeks, previous enrolment in any malaria trial, severe malnutrition (weight‐for‐age ≤ 3 standard deviations below mean for gender according to WHO standards). |
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Interventions | 1. DHA‐P, fixed dose combination, 20 mg/160 mg tablets (DuoCotexin: Beijing Holley‐Cotec)
2. Artemether‐lumefantrine, fixed dose combination, 20 mg/120 mg (Coartem: Novartis)
All doses, except AL evening doses, administered under direct supervision. |
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Outcomes |
Not included in this review:
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Notes | Country: Kenya Setting: district hospital in western Kenya Transmission: Holoendemic with high transmission and two seasonal peaks, April to July and November to December Resistance: Not reported Dates: Oct 2010 to Aug 2011 Funding: KEMRI/CDC Research and Public Health Collaboration, Beijing Holley‐Cotec provided DHA‐P free of charge. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "children were block randomized in fixed blocks of ten to treatment". |
Allocation concealment (selection bias) | Unclear risk | None described. |
Blinding for microscopy outcomes (performance bias and detection bias) | Low risk | "All microscopists were blinded to the treatment arm". |
Blinding for adverse events (performance and detection bias) | Unclear risk | No other blinding reported. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Percentage withdrawn from analysis high in both treatment groups (17.5% DHA‐P versus 18.2% AL). |
Selective reporting (reporting bias) | Low risk | All WHO outcomes reported. |
Other bias | Low risk | No other forms of bias identified. |