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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-08-31

Study Completion Date

2011-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ciproxin-inhaled Colistin

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

Group Type ACTIVE_COMPARATOR

oral ciprofloxacin plus inhaled colistin

Intervention Type DRUG

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

Tobramycine for inhalation (TIS)

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

Group Type ACTIVE_COMPARATOR

TOBI

Intervention Type DRUG

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

Interventions

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oral ciprofloxacin plus inhaled colistin

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

Intervention Type DRUG

TOBI

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

Intervention Type DRUG

Other Intervention Names

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Ciproxin ® - ciprofloxacin Colistineb ® TOBI® - tobramycin inhalation solution (TIS)

Eligibility Criteria

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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.

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No