Duration of Antibiotics in Infective Exacerbations of Cystic Fibrosis
- Registration Number
- NCT01044719
- Lead Sponsor
- Imperial College London
- Brief Summary
Cystic Fibrosis patients attending with infective exacerbations will be enrolled into the study. The trial is a double blinded, randomised trial with patients randomised to 10,14 or 21 days of antibiotic therapy, comprising of tobramycin and either ceftazidime or meropenem.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 240
Inclusion Criteria
- 16 years or older
- Diagnosis of Cystic Fibrosis
- Presenting with Infective exacerbation
Exclusion Criteria
- Unable to give consent
- Allergy to study medications
- Intolerance of aminoglycoside antibiotics
- Pseudomonas resistant to study antibiotics
- On the active transplant list or FEV1<20% predicted
- Pregnancy/breast-feeding
- Co-existent ABPA requiring a change in treatment
- Co-existent mycobacterial infection
- A previous participant in the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 14 days Tobramycin - 14 days Ceftazidime - 10 days Ceftazidime - 10 days Tobramycin - 10 days Meropenem - 21 days Tobramycin - 14 days Meropenem - 21 days Ceftazidime - 21 days Meropenem -
- Primary Outcome Measures
Name Time Method Treatment failure at completion of antibiotic course 21 days Time to next exacerbation 6 months
- Secondary Outcome Measures
Name Time Method Change in Spirometry up to 21 days Change in inflammatory markers up to 21 days Change in sputum bacteriology up to 21 days Adverse effects of study antibiotics Up to 21 days Quality of life scores Up to 21 days Change in nutritional status up to 21 days
Trial Locations
- Locations (1)
Department of Cystic Fibrosis, Royal Brompton Hospital
🇬🇧London, United Kingdom