Hasugian 2007 IDN.
Methods | Trial design: An open label RCT Follow‐up: Daily until fever and parasites cleared then weekly until day 42, for a physical examination, a symptom questionnaire and malaria film. Hb measured on days 0, 7, and 28. Adverse event monitoring: Assessed at each follow‐up visit |
|
Participants | Number of participants: 340 Inclusion criteria: Age > 1 yr, weight > 5 kg, slide confirmed malaria (P. falciparum, P. vivax or both), fever or history of fever in the preceding 48 hrs Exclusion criteria: Pregnancy or lactation, danger signs or signs of severe malaria, > 4% red blood cells parasitized, concomitant disease that required hospital admission |
|
Interventions | 1. DHA‐P, fixed dose combination (Artekin: Holley)
2. Artesunate plus amodiaquine, loose combination (Arsumax: Guilin, Flavoquine: Aventis)
All doses supervised |
|
Outcomes |
Not included in the review:
|
|
Notes | Country: Indonesia Setting: Rural clinics Transmission: Unstable Resistance: Chloroquine and SP resistance Dates: Jul 2005 to Dec 2005 Funding: Wellcome Trust ‐ National Health and Medical Research Council. |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "A randomisation list was generated in blocks of 20 by an independent statistician". |
Allocation concealment (selection bias) | Low risk | "Treatment allocation concealed in an opaque, sealed envelope that was opened once the patient had been enrolled". |
Blinding for microscopy outcomes (performance bias and detection bias) | Low risk | "All slides were read by a certified microscopist who was blinded to treatment allocation". |
Blinding for adverse events (performance and detection bias) | High risk | An open‐label trial. |
Incomplete outcome data (attrition bias) All outcomes | High risk | The primary outcome data are unpublished data including only participants with P. falciparum mono or co‐infection at baseline. High losses to follow‐up in both groups at day 42 (21% DHA‐P versus 24.5 % AL6), moderate at day 28 (16.6% DHA‐P versus 18.8 % AL6). |
Selective reporting (reporting bias) | Low risk | All WHO outcomes reported. Day 42 outcomes may underestimate failure with DHA‐P due to its long half‐life. |
Other bias | Low risk | No other sources of bias identified. |