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

Janssens 2007 KHM.

Methods Trial design: An open label RCT
Follow‐up: Monitored daily until fever and parasites cleared then weekly to day 63. Temperature, symptom questionnaire, malaria film, and haematocrit at each visit.
Adverse event monitoring: An adverse event defined as any new sign or symptom appearing after treatment started. At each visit a symptom questionnaire was completed.
Participants Number of participants: 464
Inclusion criteria: Age > 1 yr, axillary temp > 37.5 °C or history of fever, signs and symptoms of uncomplicated malaria, P. falciparum mono or mixed infections, written informed consent
Exclusion criteria: Pregnancy or lactation, signs or symptoms of severe malaria, > 4% red blood cells parasitized, a history of convulsions or neuropsychiatric disorder, treatment with mefloquine in the past 60 days.
Interventions 1. DHA‐P, fixed dose combination, 40 mg/320 mg tablets (Artekin: Holleykin)
  • Adult total dose: 6 mg/kg DHA and 48 mg/kg P in 4 divided doses, given at 0, 8, 24, and 48 hrs

  • Children total dose: 6.4 mg/kg DHA + 51.2 mg/kg P in 4 divided doses, given at 0, 8, 24, 48 hrs


2. Artesunate plus mefloquine, loose combination (Artesunate: Guilin, Mefloquine: Mepha)
  • Adults: 100 mg AS plus 500 mg MQ twice daily on day 0, then 200 mg AS once daily on day 1 and day 2

  • Children: AS 4 mg/kg once daily for 3 days plus 25 mg/kg MQ split into 2 doses on day 0


All doses supervised.
Outcomes
  1. Cure rate at days 63, 42, and 28, PCR‐adjusted and PCR‐unadjusted

  2. P. vivax parasitaemia during follow‐up

  3. Mean haematocrit at day 0 and 63

  4. Adverse effects


Not included in the review:
  1. Fever clearance

  2. Parasite clearance

Notes Country: Cambodia
Setting: Rural health centres and outreach malaria clinics
Transmission: Low and seasonal
Resistance: Multiple‐drug resistance
Dates: Oct 2002 to March 2003
Funding: Médecins sans Frontières
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "Computer generated randomisation (STATA version 8, Statacorp)".
Allocation concealment (selection bias) Unclear risk "Treatment allocations were concealed in sealed 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 Losses to follow‐up balanced and low in both groups (9.3% DHA‐P versus 10% AS+MQ).
Selective reporting (reporting bias) Low risk All WHO outcomes reported.
Other bias Low risk No other sources of bias identified.