Milla 2013.

Study characteristics
Methods	Double‐blind, placebo‐controlled single‐dose RCT. Parallel design (3‐armed). Location: 10 CF centres in the USA. Duration: single‐dose given on day 0 and followed up until day 56.
Participants	27 participants (aged over 12 years) with P aeruginosa infection. KB001‐A 3 mg/kg n = 10; KB001‐A 10 mg/kg n = 8; placebo n = 9. Age, mean (range): 3 mg/kg 29.9 (17 – 58) years; 10 mg/kg group 27.8 (20 – 37) years; placebo 33.4 (19 – 55) years. Gender split, n (%): 3 mg/kg group 5 males (50%); 10 mg/kg group 6 males (75%); placebo 7 males (78%). Baseline FEV1 % predicted, mean (SD): 3 mg/kg group 75.2% (21.4); 10 mg/kg group 69.6% (19.7); placebo 67.8% (13.0). Baseline CFQ‐R respiratory symptom score, mean (SD): 3 mg/kg group 66.7 (7.4); 10 mg/kg group 75.0 (14.6); placebo 71.6 (15.3). Baseline sputum P aeruginosa density log10 CFU/g, mean (SD): 3 mg/kg group 8.00 (1.20); 10 mg/kg group 7.80 (0.73); placebo 7.33 (2.07).
Interventions	KB001‐A is a monoclonal antibody that works by inactivating the infection mechanism of P aeruginosa. Intervention 1: KB001‐A (3 mg/kg), single IV infusion given over 1 hour. Intervention 2: KB001‐A (10 mg/kg), single IV infusion given over 1 hour. Control: placebo (0.9 % sodium chloride), single IV infusion given over 1 hour.
Outcomes	Safety outcomes, adverse events, inflammatory markers, CFQ‐R respiratory domain scores, spirometry (FEV1, FEF25-75, FVC) Outcomes were reported at baseline and day 28 and day 56.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Described as "randomized" but no detail provided.
Allocation concealment (selection bias)	Unclear risk	No detail provided.
Blinding (performance bias and detection bias) PUFA first	Low risk	Research teams and participants were blinded. Unblinded pharmacists prepared the infusion bags but labelled bags to maintain blinding.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	27 participants randomised. 2 participants discontinued the trial, 1 from each of the KB001‐A groups (due to infusion related AE). A further 2 from the KB001‐A 3 mg/kg group were excluded from the analysis (received prohibited medications) and 1 from the placebo group for the same reason. All participants were included in the safety analysis.
Selective reporting (reporting bias)	Low risk	Protocol deposited on clinicaltrials.gov. Primary outcomes are safety and tolerability which are reported.
Other bias	Unclear risk	The trial was sponsored by the pharmaceutical company developing KB001‐A.