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

Universitaire Ziekenhuizen KU Leuven61 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cystic Fibrosis

Interventions

oral ciprofloxacin plus inhaled colistinDRUG

oral ciprofloxacin (30mg/kg/day divided in 2 doses) for 3 months (CC) plus inhaled colistimethate sodium(Colistineb® 2x2 mill U daily)

TOBIDRUG

tobramycin inhalation solution (TOBI® 2x300 mg) for 28 days

Eligibility

Sex: ALLMax age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Department of pediatrics, CF center Uuiversity Hospital Leuven

Leuven, Belgium

Outcomes

Primary Outcomes

Pseudomonas aeruginosa eradication at the end of the treatment.

sucessful eradication is defined as negative airway culture for P aeruginosa and end of study drug which is after 3 months for ciproxin-colistin (CC) and after 1 months for tobramycin for inhalation (TIS)

Time frame: end of study drug treatment ie 3 months for CC and at 1 months for TIS

Secondary Outcomes

P aeruginosa eradication at 6 months after study entry

negative airway cultures for P aeruginosa up to 6 months after start of study drug

Time frame: 6 months

time to new Pa positive culture (= relapse)

Time to first new P aeruginosa positive airway culture (expressed in months starting from end of study drug)

Time frame: 1 year

change from baseline FEV1% pred, IgG z score, BMI z score was followed

Evolution of lung function (expressed as FEV1% pred), total IgG and nutritional status (expressed as BMI z score) from start of study up to 1 year

Time frame: 1 year

Antibody titer for specific anti Pseudomonas antibodies

Pa antibodies (ELISA St Ag 1-17 )were measured at baseline and at 1 year follow-up

Time frame: 1 year

P aeruginosa infection status

P aeruginosa infection status was reported as 'Free off', 'Intermittent' or 'Chronic' according to the Leeds criteria after 1 and 2 years. (ref Leeds criteria: Lee TW, Brownlee KG, Conway SP, et al. Evaluation of a new definition for chronic Pseudomonas aeruginosa infection in cystic fibrosis patients. J Cyst Fibros 2003;2(1):29-34)

Time frame: 1 year

Data from ClinicalTrials.gov

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