Taccetti 2012.

Methods	RCT. Parallel design. Duration: 28 days. Multicentre (13 centres) in Italy.
Participants	223 participants with first ever or new P aeruginosa infection. New infection defined as P aeruginosa isolation following bacterial clearance documented by 3 negative cultures within the previous 6 months. Age: over 1 year. Gender: 116 male, 107 female.
Interventions	Group A (n = 105; 52 male and 53 female): 28 days 2x daily inhalation of 2 MU colistin with 2x daily doses of ciprofloxacin 15 mg/kg/dose. Group B (n = 118; 64 male and 54 female): 28 days therapy with TSI (300 mg 2x daily) with 2x daily doses of ciprofloxacin 15 mg/kg/dose.
Outcomes	Primary outcome P aeruginosa eradication defined as 3 negative cultures over 6 months. Secondary outcomes Lung function (FEV₁). Period of time free of P aeruginosa. Isolation of other pathogens including gram‐negative and aspergillus.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation sequence generated by statistical software within permuted blocks of size 10, stratified according to age and FEV₁.
Allocation concealment (selection bias)	Low risk	Separation of individuals responsible for randomisation and treatment assignment.
Blinding (performance bias and detection bias) All outcomes	High risk	Open‐label trial so no blinding of participants nor researchers.
Incomplete outcome data (attrition bias) All outcomes	Low risk	38 of 223 randomised participants (17%) dropped out of the trial. The biggest reason for dropping out was lack of compliance with follow up protocol (11 from Group A and 13 from Group B) and identification of a pulmonary exacerbation during early eradication therapy (4 from Group A and 5 from Group B). Analysis was by intention‐to‐treat.
Selective reporting (reporting bias)	Unclear risk	We have been unable to locate a published protocol for this trial. The details published on the EudraCT database (number 2008‐006502‐42) describe objectives but not outcomes. In the main paper, the methods section does not describe all the trial objectives. Only eradication, time free of P aeruginosa and spirometry are described in the methods section. These outcomes plus the additional outcomes of isolation of other organisms and adverse events are described in the results.
Other bias	Low risk	No evidence of other bias identified.