Cystic Fibrosis
Conditions
Keywords
cystic fibrosis- P aeruginosa- eradication-child
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.
Interventions
DRUGoral 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)
DRUGTOBI
tobramycin inhalation solution (TOBI® 2x300 mg) for 28 days
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 1 year | 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) |
Countries
Belgium
Outcome results
None listed