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

Lacerda 2019.

Study characteristics
Methods Multicentre, double‐blind, double‐dummy RCT
Trial phase: III
Trial design: parallel‐group trial
Participants Number randomized: 522
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 Hb < 7 g/dL

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

  • mixed malaria

  • prolonged QT interval on ECG or elevation of ALT < 2 times upper normal limit

Interventions All participants received the standard adult dose of CQ 1500 mg over 3 days to eradicate the current infection plus:
  • TQ 300 mg single dose (n = 260)

  • PQ 15 mg/day for 14 days (n = 129)

  • TQ/PQ matched placebo (n = 133)

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 (including a drop in Hb > 3 g/dL or 30% from baseline)


Outcomes not included in this review:
  • number of recurrences at 33 days and 4 months

  • time to recurrence

  • time to parasite clearance

  • time to fever clearance

  • P vivax gametocyte clearance

Notes Location: Ethiopia, Peru, Thailand, Cambodia, Brazil, Philippines
Setting: local 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: "With the use of a computer‐generated randomisation schedule provided by GlaxoSmithKline, on day 1 eligible participants were randomly assigned, in a 2:1:1 ratio…"
Allocation concealment (selection bias) Low risk Quote: "Patients and trial staff were unaware of the group assignments."
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐blind, double‐dummy study.
Blinding of outcome assessment (detection bias)
All outcomes Low risk Double‐blind study.
Incomplete outcome data (attrition bias)
All outcomes Low risk Attrition rate in all groups < 5% of number randomized.
Selective reporting (reporting bias) Low risk All participants were accounted for.
Other bias Low risk None identified.