What duration of intravenous antibiotic therapy should be used in the treatment of infective exacerbations of cystic fibrosis in patients chronically colonised with Pseudomonas aeruginosa? - Duration of antibiotics in infective exacerbations of cystic fibrosis

Conditions: Cystic Fibrosis

Registration Number: EUCTR2009-014042-28-GB

Lead Sponsor: Imperial College, London

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 240

Inclusion Criteria

Confirmed diagnosis of cystic fibrosis (sweat test and/or gene typing). All patients attending the adult CF unit for treatment for an infective exacerbation of cystic fibrosis caused by Pseudomonas aeruginosa.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients will be excluded from the study if any of the following apply: -unable to give consent -allergy to tobramycin and/or both meropenem and ceftazidime -intolerance of aminoglycoside antibiotics -Pseudomonas resistant to both meropenem and ceftazidime. -on the active transplant list or baseline FEV1 <20% predicted -pregnancy or breast-feeding -co-existent active allergic bronchopulmonary aspergillosis requiring a change in steroid or antifungal therapy -co-existent mycobacterial infection -a previous participant in this study No patient will be excluded on the basis of disability (unless their disability is such to prevent them giving proper informed consent), gender, race, ethnic origin or nationality, religion or belief, or sexual orientation.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: What is the optimal duration for an antibiotic course to treat an infective exacerbation of cystic fibrosis caused by the organism Pseudomonas aeruginosa?;Secondary Objective: ;Primary end point(s): We have two primary outcome measures, a short term and a long term outcome measure. Short term primary outcome measure: Treatment success/failure at completion of the antibiotic course Long term primary outcome measure: Time to next exacerbation for those deemed a treatment success at the end of the antibiotic course

Secondary Outcome Measures