Kolaczinski 2012
| Methods | Individually RCT Dates of trial: between July and January, from 2000 to 2003. | |
| Participants | 237 individuals aged from 3 to 70 years, in 5 villages for Afghan refugees in Pakistan. Inclusion: = 2 years of age, P. falciparum mono-infection, confirmed by slide, will be resident during entire follow-up period. Exclusions: Pregnancy, signs of severe malaria, report of antimalarial drug in past 21 days, other serious disease | |
| Interventions | 1. CQ: 3 days 25 mg/kg. 2. CQ+PQ: CQ as in 1; PQ on day 3 (0.5 mg/kg). 3. SP: 25(S)/1.25(P) mg/kg in single dose. 4. SP+PQ: SP as in 3; PQ on same day (0.5 mg/kg). | |
| Outcomes | 1. Clinical treatment failure (PCR non-adjusted and adjusted). 2. Gametocytes on day 8. 3. Gametocyte density on days 1 to 8 of follow-up. 4. Genotyping of resistant strains for CQ and SP-specific mutations. | |
| Notes | Also included CQ + AS and SP + AS arms, compared with CQ +/- PQ and SP +/- PQ arms, respectively. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Patients numbered sequentially at enrolment. Random numbers with treatment assignment from Excel-generated lists, then paired with patient numbers. |
| Allocation concealment (selection bias) | Low risk | Patient number concealed until after enrolment. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 209 of 237 randomized completed treatment and at least one follow-up test. 47 (13%) of those randomized did not contribute data. Variable numbers tested during follow-up (see analyses). |
| Selective reporting (reporting bias) | Low risk | None detected. |
| Other bias | Low risk | None noted. |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Identified in report as 'single-blind'. Manager (gave Rx) not blinded; patients, microscopists and health workers 'partially blinded' due to different drug appearance and times of follow-up. No placebos used, but vitamin given to those in non-PQ arms. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Implied only. |