Macfarlane 1985.
| Methods | Double‐blind placebo‐controlled RCT. Parallel design. Duration: 14 days. Single centre. Country: Australia. |
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| Participants | 19 participants aged over 8 years with CF with P. aeruginosa in sputum admitted to hospital for worsening respiratory status. Intervention 1: 4 participants; mean (SD) age 15.3 (3) years. Intervention 2: 5 participants; mean (SD) age 12.5 ( 2.9) years. Intervention 3: 4 participants; mean (SD) age 13.7 ( 2.6) years. Intervention 4: 5 participants; mean (SD) age 15.6 (3.4) years. Gender split not detailed. |
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| Interventions | Intervention 1: IV piperacillin 50 mg/kg 4‐hourly. Intervention 2: IV placebo 5% dextrose 4‐hourly. Intervention 3: IV piperacillin 100 mg/kg 8‐hourly. Intervention 4: IV placebo 5% dextrose 8‐hourly. All participants received IV tobramycin 2.5 mg/kg 3x daily, oral flucloxacillin 25 mg/kg/day in 4 doses and oral probenecid (suggested to increase antibiotic concentrations) 250 ‐ 500 mg 3x daily. |
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| Outcomes | Lung function (FEV1, VC, RV, TLC, FEF25‐75%), weight, symptom and clinical score, mortality, microbiology. | |
| Notes | UoA issues ‐ 1 participants received 2 courses. We shall seek to contact the authors for IPD to reconcile the UoA issues and for data to contribute to a meta‐analysis. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Described as randomly assigned but no method given. |
| Allocation concealment (selection bias) | Unclear risk | No method described. |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Described as double‐blind. Identities of infusions known only to pharmacy personnel. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Described as double‐blind. |
| Incomplete outcome data (attrition bias) All outcomes | High risk | 2 participants withdrew and did not contribute data to the analysis. |
| Selective reporting (reporting bias) | Unclear risk | Insufficient information. |
| Other bias | High risk | UoA issues ‐ 1 participant received 2 treatment courses. |