Master 1997.
Methods | Double‐blind trial, symptomatic regimen. Parallel trial. | |
Participants | 83 participants randomised. PsA colonised, age not stated. 51 participants randomized, of these, 21 in the tobramycin and ceftazidime group (51 admissions assessed) and 23 in the tobramycin group (47 admissions assessed). 12 participants in the tobramycin and ceftazidime group and 9 participants in the tobramycin group were eligible for long‐term assessment. Participants in both groups experienced an average of 3.1 and 3.0 admissions, respectively, for IV antibiotic treatment during the study period. Tobramycin and ceftazidime group: mean (SD) age 16 (7) years Tobramycin group: mean (SD) age 14 (5) years |
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Interventions | Tobramycin 24‐hourly vs tobramycin and ceftazidime 8‐hourly. 10‐day course. | |
Outcomes | Lung function, adverse events. | |
Notes | Full paper. Exclusion criteria stated. The study was halted for a period of 3 months when one of the study patients committed suicide by utilizing a study syringe to administer a lethal substance. The study was recommenced after the coroner's finding that this was an unrelated death. During this time of study suspension, there were 14 admissions of patients previously enrolled. Data from these admissions were not included. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomization was stratified for age and disease severity. |
Allocation concealment (selection bias) | Low risk | The treatment code was broken only at the completion of the study. |
Blinding (performance bias and detection bias) All outcomes | Low risk | Medical staff, nursing staff and participants were blinded to the treatment. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Flow chart showing numbers randomized and included/excluded (with reasons) at each stage in paper. |