Kamtekar 2004

Methods	Individually RCT, comprising two distinct comparisons a: (CQ or [CQ+SP]) with and without PQ and b: QN with and without PQ. Dates of trial: not given.
Participants	57 people aged ≥ 16 years with symptomatic uncomplicated and 46 with severe (WHO criteria) P. falciparum malaria, diagnosed by thick and thin blood slides. Gametocytaemic within first 72 hrs with = 55 P. falciparum gametocytes/μL Site: urban areas of Mumbai, India. Exclusion criteria: Pregnant or lactating, treatment for malaria within last two weeks, co-infection with P.vivax, history of PQ allergy.
Interventions	Comparison a: for uncomplicated malaria All received CQ (some also got SP) Day 4: randomized to PQ or placebo (45 mg) Comparison b: for severe malaria All received quinine Day 8: randomized to PQ or placebo (dose 45 mg) Doses background drugs: CQ 10 mg/kg on days 1 and 2; 5 mg/kg on day 3; SP 1500 mg; quinine dose 10 mg/kg every 8 hrs for 24 to 48 hrs and orally for total of 7 days
Outcomes	1. Proportion of people with gametocytes, days 1, 4, 8, 15, 22, 29. 2. Proportion of people with viable gametocytes (exflagellation), days 1, 4, 8, 15, 22, 29. 3. Gametocyte density (given as range) days 1, 4, 8, 15, 22, 29.
Notes	No screening for G6PD deficiency. It is not stated how many got SP in addition to CQ or why.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	"simple computer generated randomization code". Not all patients had gametocytes on day 1. Inclusion criteria were that the person had to have gametocytes in the first 72 hours (from day 1?). This suggests some post randomization inclusions or exclusions.
Allocation concealment (selection bias)	Unclear risk	No information.
Incomplete outcome data (attrition bias) All outcomes	High risk	Originally there were 57 people included in uncomplicated comparison (a), of whom 2 were lost to follow-up and 9 were not evaluated as they showed CQ resistance. There were 46 in severe comparison (b), of whom 3 were lost to follow-up. The final numbers evaluated in each group were (a) 22 and 24 (b) 22 and 21.
Selective reporting (reporting bias)	Unclear risk	No obvious selective reporting.
Other bias	High risk	It was not clear why some patients got SP and others did not, and the numbers in each group are not given.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Trial used a placebo for PQ. Patients and health workers were blinded.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Slide readers were blinded.