Zongo 2007 BFA.
Methods | Trial design: A 3‐arm RCT Follow‐up: A standardized history, examination, and malaria film on days 0, 1, 2, 3, 7, 14, 21, 28, 35, and 42. Hb measured on days 0 and 42 or day of clinical failure. Children with Hb < 10 g/dL were treated with ferrous sulphate and antihelminthic treatment. Adverse event monitoring: Assessed at each visit. Adverse events defined as untoward medical occurrences. |
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Participants | Number of participants: 580 Inclusion criteria: Age > 6 months, weight > 5 kg, axillary temp > 37.5 °C or history of fever in the last 24 hrs, P. falciparum mono‐infection 2000 to 200,000/µL, the ability to participate in 42 days follow‐up, informed consent. Exclusion criteria: Danger signs or signs of severe malaria, history of serious adverse effects related to trial medications, evidence of concomitant febrile illness, antimalarial use other than chloroquine in previous two weeks, Hb < 5 g/dL. |
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Interventions | 1. DHA‐P, fixed dose combination, 40 mg/320 mg tablets (Duocotexin: HolleyPharm)
2. Artemether‐lumefantrine, fixed dose combination, 20 mg/120 mg tablets (Coartem: Novartis)
3. Amodiaquine plus sulfadoxine‐pyrimethamine, loose combination (Flavoquine: Aventis, Fansidar: Roche)
All doses supervised |
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Outcomes |
Not included in this review:
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Notes | Country: Burkino Faso Setting: Health dispensaries Transmission: Holoendemic, transmission principally in the rainy season May to Oct Resistance: Not reported Dates: Not reported Funding: Doris Duke Charitable Foundation, Holley Cotec Pharmaceuticals, International Atomic Energy Agency, National Budget of the Institut de Recherche en Sciences de la Sante |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Randomly assigned on the basis of a computer‐generated code provided by an off‐site investigator". |
Allocation concealment (selection bias) | Low risk | "Referred for treatment allocation by a study nurse not involved in enrolment or assessment of treatment outcomes". |
Blinding for microscopy outcomes (performance bias and detection bias) | High risk | "The study was not blinded". |
Blinding for adverse events (performance and detection bias) | High risk | As above. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Low losses to follow‐up in all groups (8% DHA‐P versus 6.4% AL6 versus 8.2% AQ+SP). |
Selective reporting (reporting bias) | Low risk | All WHO outcomes reported. Day 42 outcomes may underestimate treatment failure with DHA‐P due to its long half‐life. |
Other bias | Low risk | No other sources of bias identified. |