Clinical trial NCT01400750: Comparison of 2 Treatment Regimens for Eradication of P Aeruginosa Infection in Children With Cystic Fibrosis
Official title: Prospective Randomized Trial Comparing Oral Ciproxin Plus Inhaled Colistin With Tobramycin for Inhalation for Eradication of P Aeruginosa Infection in Children With Cystic Fibrosis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cystic Fibrosis
Keywords: cystic fibrosis- P aeruginosa- eradication-child
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2011-07-22
Enrollment: 61
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 (Colistineb® 2x2 mill U daily) plus oral ciprofloxacin (30mg/kg/day) for 3 months (CC). The primary outcome was eradication at end of treatment. Secondary outcome parameters were time to Pa relapse, total and Pa specific IgG, FEV1, BMI and Pa status.

Eligibility 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.

Primary outcomes:
measure: Pseudomonas aeruginosa eradication at the end of the treatment.
timeFrame: end of study drug treatment ie 3 months for CC and at 1 months for TIS
Secondary outcomes:
measure: P aeruginosa eradication at 6 months after study entry
timeFrame: 6 months
measure: time to new Pa positive culture (= relapse)
timeFrame: 1 year
measure: change from baseline FEV1% pred, IgG z score, BMI z score was followed
timeFrame: 1 year
measure: Antibody titer for specific anti Pseudomonas antibodies
timeFrame: 1 year
measure: P aeruginosa infection status
timeFrame: 1 year
measure: P aeruginosa infection status
timeFrame: 2 years
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Department of pediatrics, CF center Uuiversity Hospital Leuven
Study officials:
affiliation: Dep pediatrics University Hospital Leuven Belgium
name: Marijke J Proesmans, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Langton Hewer SC, Smyth AR. Antibiotic strategies for eradicating Pseudomonas aeruginosa in people with cystic fibrosis. Cochrane Database Syst Rev. 2009 Oct 7;(4):CD004197. doi: 10.1002/14651858.CD004197.pub3.