Status:
COMPLETED
Comparison of 2 Treatment Regimens for Eradication of P Aeruginosa Infection in Children With Cystic Fibrosis
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE4
Brief 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.
Detailed Description
Methods: CF children (0-18 years) with a new isolation of Pa from the airway were randomized to tobramycin inhalation solution (TOBI® 2x300 mg for 28 days) (TIS) or inhaled colistimethate sodium (Coli...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT01400750
Start Date
August 1 2001
End Date
May 1 2011
Last Update
August 4 2011
Active Locations (1)
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1
Department of pediatrics, CF center Uuiversity Hospital Leuven
Leuven, Belgium, 3000