Comparison of 2 Treatment Regimens for Eradication of P Aeruginosa Infection in Children With Cystic Fibrosis
- Conditions
- Cystic Fibrosis
- Interventions
- Registration Number
- NCT01400750
- Lead Sponsor
- Universitaire Ziekenhuizen KU Leuven
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 61
- 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'.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ciproxin-inhaled Colistin oral ciprofloxacin plus inhaled colistin oral ciprofloxacin (30mg/kg/day) plus inhaled colistimethate sodium (Colistineb® 2x2 mill U daily) for 3 months Tobramycine for inhalation (TIS) TOBI tobramycin inhalation solution (TOBI® 2x300 mg) for 28 days
- Primary Outcome Measures
Name Time Method Pseudomonas aeruginosa eradication at the end of the treatment. end of study drug treatment ie 3 months for CC and at 1 months for TIS 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)
- Secondary Outcome Measures
Name Time Method P aeruginosa eradication at 6 months after study entry 6 months negative airway cultures for P aeruginosa up to 6 months after start of study drug
time to new Pa positive culture (= relapse) 1 year Time to first new P aeruginosa positive airway culture (expressed in months starting from end of study drug)
change from baseline FEV1% pred, IgG z score, BMI z score was followed 1 year 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
Antibody titer for specific anti Pseudomonas antibodies 1 year Pa antibodies (ELISA St Ag 1-17 )were measured at baseline and at 1 year follow-up
P aeruginosa infection status 2 years 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)
Trial Locations
- Locations (1)
Department of pediatrics, CF center Uuiversity Hospital Leuven
🇧🇪Leuven, Belgium