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

Mens 2008 KEN.

Methods Trial design: An open label RCT
Follow‐up: Malaria film and Hb level on days 0, 1, 2, 3, 7, 14, and 28, plus QT‐NASBA for detection of sub‐microscopic gametocytaemia
Adverse event monitoring: Adverse events were recorded at each visit in the case record form. An adverse event defined as any unfavourable and unintended sign.
Participants Number of participants: 146
Inclusion criteria: Age 6 months to 12 years, axillary temp > 37.5 °C or history of fever, P. falciparum mono‐infection 1000 to 200,000/µL, informed consent
Exclusion criteria: Severe malaria, any other underlying illness
Interventions 1. DHA‐P, fixed dose combination, 20 mg/160 mg tablets (Sigma‐Tau)
  • 4 to 7 kg ½ tablet once daily for 3 days

  • 7 to 13 kg 1 tablet once daily for 3 days

  • 13 to 24 kg 2 tablets once daily for 3 days

  • 24 to 35 kg 4 tablets once daily for 3 days


2. Artemether‐lumefantrine, fixed dose combination, 20/120 mg tablets (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


All doses supervised and given with a glass of milk.
Outcomes
  1. Recurrent parasitaemia at day 28, PCR‐adjusted and PCR‐unadjusted

  2. Gametocyte prevalence during follow‐up

  3. Mean Hb at day 28

  4. Adverse events


Not included in this review:
  1. Fever clearance

  2. Parasite clearance

Notes Country: Kenya
Setting: Health centre
Transmission: High transmission
Resistance: Not reported
Dates: Apr 2007 to Jul 2007
Funding: The Knowledge and Innovation Fund, Koninklijk Instituut voor de Tropen/Royal Tropical Institute. DHA‐P provided free of charge by Sigma‐Tau.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "A computer generated randomisation list".
Allocation concealment (selection bias) Unclear risk None described.
Blinding for microscopy outcomes (performance bias and detection bias) Low risk Microscopists were blinded to treatment allocation.
Blinding for adverse events (performance and detection bias) Unclear risk No other blinding described.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Low losses to follow‐up in both groups (8.2% DHA‐P versus 8.2% AL6).
Selective reporting (reporting bias) Low risk The WHO recommends 42 days follow‐up in studies of AL6. Day 28 outcomes may underestimate treatment failure with AL6 and DHA‐P.
Other bias Low risk No other sources of bias identified.