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

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
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
Interventions 1. DHA‐P, fixed dose combination, 40 mg/320 mg tablets (Artekin: Holleykin)
  • Total dose: DHA 6.75 mg/kg + P 54 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)
  • 10 to 15 kg 1 tablet twice daily for 3 days

  • 15 to 25 kg 2 tablets twice daily for 3 days

  • 25 to 35 kg 3 tablets twice daily for 3 days

  • > 35 kg 4 tablets twice daily for 3 days


Only the first dose of each day was supervised. All participants advised to take each dose with a biscuit or milk.
Outcomes
  1. Parasitological failure at days 42 and 28, PCR‐adjusted and PCR‐unadjusted

  2. P. vivax during follow‐up

  3. Gametocyte carriage after treatment

  4. Anaemia during follow‐up

  5. Adverse events


Not included in the review:
  1. Fever clearance

  2. Parasite clearance

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
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.