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. 2020 Sep 6;2020(9):CD010458. doi: 10.1002/14651858.CD010458.pub3

Llanos‐Cuentas 2014.

Study characteristics
Methods Multicentre, double‐blind RCT
Trial phase: IIb
Trial design: parallel‐group, dose‐ranging trial
Participants Number randomized: 329
Inclusion criteria:
  • males and females aged ≥ 16 years with clinical symptoms of malaria with P vivax monoinfection with an asexual parasite density > 100/µL and < 100,000/µL of blood


Exclusion criteria:
  • receiving antimalarial treatment within 30 days of screening

  • severe malaria, any clinically significant concurrent illness

  • severe vomiting or a Hb < 7 g/dL

  • pregnancy or G6PD enzyme activity < 70% of the site median

Interventions All participants received the standard adult dose of CQ (1500 mg) over 3 days to eradicate the current infection plus:
  • TQ 50 mg single dose (n = 55)

  • TQ 100 mg single dose (n = 57)

  • TQ 300 mg single dose (n = 57)

  • TQ 600 mg single dose (n = 56)

  • TQ/PQ matched placebo (n = 54)

  • PQ 15 mg/day for 14 days (n = 50)

Outcomes Outcomes included in this review:
  • recurrence of microscopically confirmed P vivax malaria after completing treatment up to 6 months

  • adverse events attributable to TQ


Outcomes not included in this review:
  • time to recurrence

  • parasite clearance time

  • fever clearance time

Notes Location: Peru, Brazil, India and Thailand
Setting: community health centres and hospitals
Endemicity: endemic for vivax malaria
Resistance: unknown
Funding: GlaxoSmithKline, Medicines for Malaria Venture
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "A computer generated randomisation schedule, stratified by baseline parasite count."
Allocation concealment (selection bias) Low risk Quote: "Patients, study staff and GlaxoSmithKline personnel were masked to study treatment allocation."
Blinding of participants and personnel (performance bias)
All outcomes Low risk Described as "Double blind, double dummy design."
Blinding of outcome assessment (detection bias)
All outcomes Low risk Described as "Double blind, double dummy design."
Incomplete outcome data (attrition bias)
All outcomes Low risk Attrition rate in all groups < 6% of the number randomized.
Selective reporting (reporting bias) Low risk Absolute number of recurrences by 6 months not mentioned. However, it could be calculated from available data. The numbers were confirmed by communication with the authors.
Other bias Low risk None identified.