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. 2014 Jun 30;(6):1–110. doi: 10.1002/14651858.CD008152.pub3

Ledermann 2006

Methods Individually RCT Date of trial: July to Oct 2001.

Participants 117 malaria cases with P. falciparum ≥ 400 asexual stages/μL (thick film) recruited by mass blood survey and passive case detection. Symptoms not required. Age: ≥ 15 years Site: Central Java, Indonesia, an area with high CQ resistance and resurgent malaria approximately equal P. falciparum and P. vivax. Exclusion criteria: Pregnancy, breast feeding, body weight < 40kg, G6PD deficiency, history of antimalarial or antibiotic in last seven days, severe or complicated malaria, history or allergy or adverse reaction to trial medications, Pv or mixed infection.

Interventions 1. CQ only (not included in this review). 2. CQ+SP: CQ 150 mg base, 10, 10 and 5 mg/kg on days 1, 2, 3 (reported as days 0, 1, 2). SP 500 mg S 25 mg P on day 1 (reported as day 0). 3. CQ+SP as for group 2 above plus PQ 45 mg on day 1 (reported as day 0). 4. CQ+SP as for group 2 above plus PQ 45 mg on day 3 (reported as day 2).

Outcomes 1. Parasite clearance time assessed at days 1, 3, 8, 15, 22, 29 or day of recurrent parasitaemia (reported as days 0, 2, 7, 14, 21, 28). 2. Fever clearance time at days 2, 3, 4, 5, 8, 12, 15, 19, 22, 29. 3. Proportion of people with gametocytes (from chart) days 1 to 29. 4. Adverse events.

Notes Some comparisons in the results reported include the CQ only group.

Risk of bias

Bias Authors' judgement Support for judgement

Random sequence generation (selection bias) Low risk Trial subject codes were assigned to treatment arms by a random process (not specified).

Allocation concealment (selection bias) High risk Eligibles were assigned a sequential participant number by the screening physician. Pre-packaged treatment but not stated whether allocation was concealed.

Incomplete outcome data (attrition bias) All outcomes Low risk 7% of participants withdrew before day 28.

Selective reporting (reporting bias) Unclear risk Abstract states that drugs were well tolerated and safe but no evidence is given in report.

Other bias Low risk No indication of other bias.

Blinding of participants and personnel (performance bias) All outcomes Unclear risk Blinding was implied only.

Blinding of outcome assessment (detection bias) All outcomes Unclear risk Blinding was implied only.