Comparison of 2 Treatment Regimens for Eradication of P Aeruginosa Infection in Children With Cystic Fibrosis

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Treatment of new Pseudomonas aeruginosa (Pa) infection in cystic fibrosis (CF) can postpone chronic infection. Aim of the study: compare 2 Pa eradication regimens in children with new Pa infection.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universitaire Ziekenhuizen Leuven
• Treatments: Ciprofloxacin; Colistin; Tobramycin

Criteria

Inclusion Criteria:

• diagnosis of CF (clinical signs consistent with CF and a sweat chloride > 60 mEq/l by quantitative pilocarpine iontophoresis and/or two CF causing mutations identified)

• age 0 to 18 years old at time of inclusion

• 'First' or 'new Pa infection' defined as 'first Pa isolation ever' or 'isolation of Pa from the airway (sputum, throat swab or BAL) after a Pa free interval of at least 6 months and documented with at least 3 negative cultures'.

Exclusion Criteria:

• chronic Pa infection defined according to the Leeds criteria[17]

• pulmonary exacerbation needing IV AB treatment at time of new Pa isolate

• Pa isolation at time of CF diagnosis

• patient already on an antipseudomonal antibiotic

• interval between positive culture and start of treatment > 4 weeks.