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

Tran 2004 VNM.

Methods Trial design: An open label RCT
Follow‐up: Malaria film on days 0, 2, and 7. Participants followed up to day 56 but further details not described
Adverse event monitoring: Not described
Participants Number of participants: 243
Inclusion criteria: Age > 2 yrs, microscopically confirmed uncomplicated P. falciparum malaria
Exclusion criteria: Pregnancy, evidence of organ dysfunction, unable to tolerate oral medication, unable to return for follow‐up, resident in Dac O for > 2 years
Interventions 1. DHA‐P, fixed dose combination, 40 mg/320 mg tablets (Artekin: Holleykin)
  • Adults: 2 tablets at 0, 6, 24, and 48 hrs

  • Children < 15 yrs: 1 tablet at 0, 6, 24, and 48 hrs


2. Artesunate plus mefloquine, loose combination (artesunate: Guilin, Lariam: Hoffman‐La Roche)
  • AS 4 mg/kg once daily for 3 days

  • MQ 25 mg base/kg as 2 divided doses 6 hrs apart on day 3

Outcomes
  1. Parasitological failure at days 42 and 28, PCR‐adjusted and PCR‐unadjusted

  2. Adverse events


Not included in this review:
  1. Fever clearance

  2. Parasite clearance

Notes Country: Vietnam
Setting: Health station
Transmission: Low and seasonal
Resistance: Multiple‐drug resistance
Dates: Nov 2001 to Mar 2002
Funding: Wellcome Trust of Great Britain
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "Patients were randomly allocated one of three treatments in a ratio of 2:2:1". No further details given.
Allocation concealment (selection bias) Unclear risk "Drugs were kept in identically numbered opaque envelopes". No further details.
Blinding for microscopy outcomes (performance bias and detection bias) Unclear risk No comment on blinding of laboratory staff.
Blinding for adverse events (performance and detection bias) High risk An open label trial.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk "There were no losses to follow‐up".
Selective reporting (reporting bias) Unclear risk It is unclear from the paper whether it is only clinical failure that is being reported.
Other bias Low risk No other sources of bias identified.