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)
2. Artesunate plus mefloquine, loose combination (artesunate: Guilin, Lariam: Hoffman‐La Roche)
|
|
Outcomes |
Not included in this review:
|
|
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. |