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

Universitaire Ziekenhuizen KU Leuven

Status and phase: Completed; Phase 4

Conditions: Cystic Fibrosis

Treatments: Drug: TOBI; Drug: oral ciprofloxacin plus inhaled colistin

Study type: Interventional

Funder types: Other

Identifiers

NCT01400750

MP1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 61 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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61 participants in 2 patient groups

Ciproxin-inhaled Colistin

Active Comparator group

Description:

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

Treatment:

Drug: oral ciprofloxacin plus inhaled colistin

Tobramycine for inhalation (TIS)

Active Comparator group

Description:

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

Treatment:

Drug: TOBI