Cystic Fibrosis
Conditions
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.
Interventions
DRUGCeftazidime
Ceftazidime 2g TDS IV
DRUGTobramycin
Tobramycin 7mg/kg/day OD IV
DRUGMeropenem
Meropenem 2g TDS IV
Sponsors
Imperial College London
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment failure at completion of antibiotic course | 21 days |
| Time to next exacerbation | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Change in sputum bacteriology | up to 21 days |
| Adverse effects of study antibiotics | Up to 21 days |
| Change in Spirometry | up to 21 days |
| Change in nutritional status | up to 21 days |
| Quality of life scores | Up to 21 days |
| Change in inflammatory markers | up to 21 days |
Countries
United Kingdom
Contacts
Primary ContactAndrew Jones, MB BChir MRCP
Outcome results
None listed