Smith 1999.
Methods | Double‐blind, computer‐generated randomisation, symptomatic regimen. Parallel trial. | |
Participants | 37 male, 39 female, mean age 16.3 years.
111 participants enrolled, 35 withdrawn. 76 participants in total aged 6 ‐ 18 years. PsA colonised. Group 1 (azlocillin): 33 participants (19 male) mean (SD) age 16.07 (7.4) years Group 2 (azlocillin & tobramycin): 43 participants (18 male) mean (SD) age 16.53 (6.9) years |
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Interventions | Azlocillin 450 mg/kg/day, 4‐hourly plus placebo vs azlocillin plus tobramycin 240 mg/m2/day, 6‐hourly, 14 days course. | |
Outcomes | Lung function, time to next admission, symptom scores, adverse events, bacteriology, inflammatory markers, resistant strains. | |
Notes | No data for symptom scores. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation balance by FVC and center. |
Allocation concealment (selection bias) | Low risk | Code generated by research pharmacist at the core center. |
Blinding (performance bias and detection bias) All outcomes | Low risk | Participants and clinicians blinded, serum concentrations monitored by unblinded 3rd party (research pharmacist). |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 35 participants withdrawn (21 from azlocillin group), reasons given in a table. |
CBC: complete blood count CXR: chest x‐ray ITT: intention‐to‐treat PsA: Pseudomonas aeruginosa