Grande 2007 PER.
Methods | Trial design: An open‐label RCT Follow‐up: Days 0, 1, 2, 3, 7, 14, 21, 28, 35, 42, 49, 56, and 63 or any other day they became ill, for a clinical assessment and malaria film. PCV measurement day 0, 7, 14 and 63. P. vivax treated with CQ. Adverse event monitoring: Assessed at each follow‐up visit, an adverse event defined as any unfavourable and unintended sign, symptom or disease temporally associated with the drug administered. Complete blood count, liver, and renal function tests at days 0 and 7. |
|
Participants | Number of participants: 522 Inclusion criteria: Age 5 to 60 yrs, fever > 37.5 °C or history of fever in the previous 24 hrs, P. falciparum mono‐infection 1000 to 200,000/µL. Exclusion criteria: Pregnancy or lactation, severe malaria, any concomitant illness or underlying disease, contraindication to any of the trial drugs, history of treatment with mefloquine in the previous 60 days or chloroquine, primaquine or quinine in previous 14 days. |
|
Interventions | 1. DHA‐P, fixed dose combination (Artekin: Holleykin)
2. Artesunate plus mefloquine, loose combination (Artesunate: Guilin, Lariam: Hoffman La‐Roche)
All doses were supervised. |
|
Outcomes |
Not included in this review:
|
|
Notes | Country: Peru Setting: Nine rural health posts Transmission: Low malaria transmission Resistance: High CQ and SP resistance Dates: July 2003 to July 2005 Funding: Directorate‐General for Development and Cooperation of the Belgian Government |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Randomized in blocks of 10". No further details given. |
Allocation concealment (selection bias) | Low risk | "Sealed opaque envelopes were opened only after the final decision to recruit the patient had been made". |
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 | Similar loss to follow‐up in both groups (8.7% DHA‐P versus 5.9% AS+MQ). |
Selective reporting (reporting bias) | Low risk | All WHO outcomes reported. |
Other bias | Low risk | No other sources of bias identified. |