Smithuis 2010 MMR.
Methods | Trial design: A 5‐arm open‐label RCT Follow‐up: Assessment done weekly for 9 weeks and at any other time they became ill. Hb was only measured on day 63. Adverse event monitoring: Specific procedures not reported. |
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Participants | Number of participants: 811 Inclusion criteria: Acute uncomplicated malaria (parasite density 500 – 200,000 parasites/µL) or mixed infection, weight > 5 kg, age > 6 months, informed consent Exclusion criteria: Pregnancy, severe malaria, severe acute malnutrition (weight‐for‐height below 70% of median with or without symmetrical peripheral oedema), history of antimalarial treatment within preceding 48 hrs, history of taking mefloquine in past 8 weeks, known history of hypersensitivity to trial drugs. |
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Interventions | 1. DHA‐P, fixed dose combination, 40 mg/320 mg adult tablets, 20 mg/160mg children's tablets
2. Artemether‐lumefantrine, fixed dose combination, 20 mg/120mg tablets
3. Artesunate amodiaquine, fixed dose combination, 25 mg/67.5mg tablets, 50 mg/135 mg tablets, 100 mg/270mg tablets
4. Artesunate plus mefloquine, fixed dose combination, 25 mg/55 mg tablets, 100mg/220mg tablets
5. Artesunate plus mefloquine, loose combination
For children, tablets were crushed and syrup added. |
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Outcomes |
Not included in the review:
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Notes | Country: Myanmar Setting: Three clinics in Rakhine state Transmission: Seasonal and generally low Resistance: No resistance reported Dates: Dec 2008 to Mar 2009 Funding: Médecins sans Frontières (Holland) and the Wellcome Trust Mahidol University Oxford Tropical Medicine Research Programme |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "random assignment was achieved by patients drawing an envelope from a box after enrolment". |
Allocation concealment (selection bias) | Unclear risk | "Treatment allocations were put in sealed envelopes in blocks of 50 for each age‐group". |
Blinding for microscopy outcomes (performance bias and detection bias) | Low risk | "Microscopists examining blood films were unaware of treatment allocation". |
Blinding for adverse events (performance and detection bias) | High risk | Described as "open‐label". |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Low losses to follow‐up in each treatment group (AA 3.2%, AL6 5.6%, AM‐F 4.1%, AM‐L 7.5%, DP 3.7%). |
Selective reporting (reporting bias) | Unclear risk | Some WHO outcomes are not reported (for example, LTF, ETF). |
Other bias | Low risk | No other sources of bias identified. |