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. |
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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. |
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Interventions | 1. DHA‐P, fixed dose combination, 40 mg/320 mg tablets (Artekin: Holleykin)
2. Artesunate plus mefloquine, loose combination (Artesunate: Guilin, Mefloquine: Mepha)
All doses supervised. |
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Outcomes |
Not included in the review:
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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 |
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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. |