Comparison of two treatment regimens for eradication of Pseudomonas aeruginosa infection in children with cystic fibrosis

J Cyst Fibros. 2013 Jan;12(1):29-34. doi: 10.1016/j.jcf.2012.06.001. Epub 2012 Jul 2.


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 (0-18 years) and a new isolation of Pa from sputum, cough swab or BAL were randomized to treatment with tobramycin inhalation solution for 28 days (TIS) or inhaled sodiumcolistimethate (2×2millU/day) plus oral ciprofloxacin (30 mg/kg/day) for 3 months (CC). Airway cultures were taken for 6 consecutive months, then every 3 months. 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 9 years (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 19 months (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 9 months (95% CI 0.0-19.0) for CC and 5 months (95% CI 1.7-8.3) for TIS (p=0.608). After 1 year, the 2 groups did not differ in change in total and Pa specific IgG, FEV(1) and BMI. After 2 years, 10% of patients had chronic Pa infection.

Conclusion: In children with CF and new Pa infection, inhalation of TIS (28 days) or CC (3 months) resulted in similar eradication success at the end of treatment (80 and 90% respectively) and similar clinical evolution during the first 2 years of follow-up.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Administration, Inhalation
  • Adolescent
  • Anti-Bacterial Agents / therapeutic use
  • Anti-Infective Agents / therapeutic use*
  • Child
  • Child, Preschool
  • Ciprofloxacin / therapeutic use*
  • Colistin / administration & dosage*
  • Cystic Fibrosis / microbiology*
  • Drug Therapy, Combination
  • Female
  • Forced Expiratory Volume
  • Humans
  • Infant
  • Male
  • Prospective Studies
  • Pseudomonas Infections / drug therapy*
  • Sputum / microbiology
  • Tobramycin / administration & dosage*
  • Treatment Outcome


  • Anti-Bacterial Agents
  • Anti-Infective Agents
  • Ciprofloxacin
  • Tobramycin
  • Colistin