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. 2014 Jan 20;2014(1):CD010927. doi: 10.1002/14651858.CD010927

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.
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.
Interventions 1. DHA‐P, fixed dose combination, 40 mg/320 mg tablets (Duocotexin: HolleyPharm)
  • Total dose: DHA 6.4 mg/kg + PQP 51.2 mg/kg in 3 divided doses, given once daily for 3 days


2. Artemether‐lumefantrine, fixed dose combination, 20 mg/120 mg tablets (Coartem: Novartis)
  • 5 to 14 kg 1 tablet twice daily for 3 days

  • 15 to 24 kg 2 tablets twice daily for 3 days

  • 25 to 34 kg 3 tablets twice daily for 3 days

  • > 35 kg 4 tablets twice daily for 3 days


3. Amodiaquine plus sulfadoxine‐pyrimethamine, loose combination (Flavoquine: Aventis, Fansidar: Roche)
  • AQ 10 mg/kg once daily on days 0 and 1, then 5 mg/kg once on day 2

  • SP 25/1.25 mg/kg on day 0


All doses supervised
Outcomes
  1. Risk of treatment failure at days 42 and 28, PCR‐adjusted and PCR‐unadjusted

  2. Gametocyte development during follow‐up

  3. Hb (mean g/dL) on day 0 and last day of follow‐up

  4. Adverse events


Not included in this review:
  1. Fever clearance

  2. Parasite clearance

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
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.