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

Hasugian 2007 IDN.

Methods Trial design: An open label RCT
Follow‐up: Daily until fever and parasites cleared then weekly until day 42, for a physical examination, a symptom questionnaire and malaria film. Hb measured on days 0, 7, and 28.
Adverse event monitoring: Assessed at each follow‐up visit
Participants Number of participants: 340
Inclusion criteria: Age > 1 yr, weight > 5 kg, slide confirmed malaria (P. falciparum, P. vivax or both), fever or history of fever in the preceding 48 hrs
Exclusion criteria: Pregnancy or lactation, danger signs or signs of severe malaria, > 4% red blood cells parasitized, concomitant disease that required hospital admission
Interventions 1. DHA‐P, fixed dose combination (Artekin: Holley)
  • Total dose: 6.75 mg/kg DHA and 54 mg/kg PQP in 3 divided doses given once daily for 3 days


2. Artesunate plus amodiaquine, loose combination (Arsumax: Guilin, Flavoquine: Aventis)
  • AS 4 mg/kg once daily for 3 days

  • AQ 10 mg/kg once daily for 3 days


All doses supervised
Outcomes
  1. Parasitological failure on days 42 and 28, PCR‐adjusted and PCR‐unadjusted

  2. Parasitological failure with P. vivax on days 42 and 28

  3. Gametocyte carriage after treatment

  4. Anaemia at days 0, 7, and 28

  5. Adverse events


Not included in the review:
  1. Fever clearance

  2. Parasite clearance

Notes Country: Indonesia
Setting: Rural clinics
Transmission: Unstable
Resistance: Chloroquine and SP resistance
Dates: Jul 2005 to Dec 2005
Funding: Wellcome Trust ‐ National Health and Medical Research Council.
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 by an independent statistician".
Allocation concealment (selection bias) Low risk "Treatment allocation concealed in an opaque, sealed envelope that was opened once the patient had been enrolled".
Blinding for microscopy outcomes (performance bias and detection bias) Low risk "All slides were read by a certified microscopist who was 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 All outcomes High risk The primary outcome data are unpublished data including only participants with P. falciparum mono or co‐infection at baseline. High losses to follow‐up in both groups at day 42 (21% DHA‐P versus 24.5 % AL6), moderate at day 28 (16.6% DHA‐P versus 18.8 % 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.