Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society vol:12 issue:1 pages:29-34
In patients with cystic fibrosis (CF), treatment of new Pseudomonas aeruginosa (Pa) infection postpones the occurrence of chronic infection, but the best eradication regimen is unknown . AIM OF THE STUDY: Compare 2 Pa eradication regimens in children with new Pa infection. METHODS: Children with CF (0-18years) and a new isolation of Pa from sputum, cough swab or BAL were randomized to treatment with tobramycin inhalation solution for 28days (TIS) or inhaled sodiumcolistimethate (2×2millU/day) plus oral ciprofloxacin (30mg/kg/day) for 3months (CC). Airway cultures were taken for 6 consecutive months, then every 3months. The primary outcome was Pa eradication at the end of treatment. Secondary outcome parameters were: time to Pa relapse from end of treatment, total and Pa specific IgG, FEV(1), BMI and Pa status at 2year follow-up. RESULTS: 58 patients with new Pa isolation were randomized. Their median age was 9years (IQR 4.7-13.1) and their median FEV(1) 98% predicted (IQR 87-107). Eighteen treatments concerned the first Pa isolation 'ever' (TIS: 8; CC: 10). For the remaining, median time since previous Pa was 19months (IQR 9-41). Eradication at end of treatment was similar for both treatments: 26/29 CC and 23/29 in TOBI treated patients (p=0.47). Median time to recurrence of Pa was 9months (95% CI 0.0-19.0) for CC and 5months (95% CI 1.7-8.3) for TIS (p=0.608). After 1year, the 2 groups did not differ in change in total and Pa specific IgG, FEV(1) and BMI. After 2years, 10% of patients had chronic Pa infection. CONCLUSION: In children with CF and new Pa infection, inhalation of TIS (28days) or CC (3months) resulted in similar eradication success at the end of treatment (80 and 90% respectively) and similar clinical evolution during the first 2years of follow-up.