Ratcliff 2007 IDN.
Methods | Trial design: An open‐label RCT Follow‐up: A symptom questionnaire, physical examination, malaria film and Hb measurement daily until fever and parasites cleared then weekly to day 42 Adverse event monitoring: A symptom questionnaire at each visit |
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Participants | Number of participants: 774 Inclusion criteria: Weight > 10 kg, fever or a history of fever in the preceding 48 hrs, slide confirmed malaria (P. falciparum, P. vivax or mixed infections) Exclusion criteria: Pregnancy or lactation, danger signs or signs of severity, parasitaemia > 4%, concomitant disease requiring hospital admission |
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Interventions | 1. DHA‐P, fixed dose combination, 40 mg/320 mg tablets (Artekin: Holleykin)
2. Artemether‐lumefantrine, fixed dose combination, 20 mg/120 mg tablets (Coartem: Novartis)
Only the first dose of each day was supervised. All participants advised to take each dose with a biscuit or milk. |
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Outcomes |
Not included in the review:
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Notes | Country: Indonesia Setting: Rural outpatient clinics Transmission: Unstable Resistance: Multiple‐drug resistance Dates: Jul 2004 to Jun 2005 Funding: Wellcome Trust UK and National Health and Medical Research Council Australia |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "A randomisation list was generated in blocks of 20 patients by an independent statistician". |
Allocation concealment (selection bias) | Low risk | "With each treatment allocation concealed in an opaque sealed envelope". No further details given. |
Blinding for microscopy outcomes (performance bias and detection bias) | Low risk | The microscopists were blinded to treatment allocation. |
Blinding for adverse events (performance and detection bias) | High risk | An open label trial. |
Incomplete outcome data (attrition bias) All outcomes | High risk | The primary outcome data are unpublished data including only participants with P. falciparum mono or co‐infection at baseline. Losses to follow‐up were high in both groups at day 42 (28.4 % DHA‐P versus 25.6 % AL6) and moderate at day 28 (19% DHA‐P versus 17.6% AL6). |
Selective reporting (reporting bias) | Low risk | All WHO outcomes reported. Day 42 outcomes may underestimate failure with DHA‐P due to its long half‐life. |
Other bias | Low risk | No other sources of bias identified. |