Pukrittayakamee 2004

Methods	Individually RCT Dates of trial not stated.
Participants	176 patients with acute uncomplicated P. falciparum. After exclusion of QN+tetracycline group: 146. Age 14 to 62. All male. Site: Hospital for Tropical Diseases, Bangkok, Thailand. Exclusion criteria: Severe malaria, mixed malaria infection, history of drug hypersensitivity, any antimalarial within last 48 hrs, urine positive for sulfonamide or 4AQ. People with G6PD deficient phenotype were excluded from receiving PQ.
Interventions	1. QN: QN sulfate (300 mg salt/tab) at 10 mg salt/kg, three times per day for 7 days. 2. QN+tetracycline (excluded from this review). 3. QN+PQ low dose: QN as above in 1 plus PQ 15 mg base/tab, 0.25 mg/kg base (adult dose 15 mg base) daily for 7 days. 4. QN+PQ high dose: QN as above in 1 plus PQ 0.50 mg/kg base (adult dose 30 mg base) daily for 7 days. 5. AS: AS 50 mg salt/tab 3.3 mg/kg (adult dose 200 mg) on day 1 and 1.65 mg/kg (adult dose 100 mg) daily on days 2 to 7. 6. AS+PQ (high dose): AS as above plus PQ 0.5 mg/kg base daily on days 1 to 7.
Outcomes	1. Parasite clearance time: measured at 12 hrs until clearance. 2. Gametocyte clearance time: median, 12 hrs until clearance. 3. Fever clearance time (measured every 4 hr at first and then every 6 to 12 hrs until resolution of fever). 4. Parasite reduction ratio at 48 hrs. 5. Reappearance of infection P. falciparum/P. vivax up to 28 days. 6. Prevalence of gametocytes on admission/after treatment/total. 7. Gametocyte carriage: total number of hours for which gametocytes were detectable.
Notes	Patients with recrudescence of P. falciparum or relapse of P. vivax were re-treated with 7 day QN+tetracycline or 'standard doses' of CQ+PQ respectively; not clear if they were excluded from further trial.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	Method not stated. Patients with G6PD deficiency were excluded from getting PQ which suggests randomization was biased.
Allocation concealment (selection bias)	Unclear risk	No information given.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	122/142 of the original participants in the 5 groups studied here completed follow-up. Patients with recrudescences of P. falciparum or relapse of P. vivax were re-treated with QN+tetracycline or CQ+PQ respectively; not clear if they were excluded from further trial.
Selective reporting (reporting bias)	Unclear risk	Not detected.
Other bias	Unclear risk	Those who were unable to stay in hospital until clearance of both fever and parasites were excluded from trial of fever clearance time.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Not reported.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not reported.