Duration of Antibiotics in Infective Exacerbations of Cystic Fibrosis
Information source: Imperial College London
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cystic Fibrosis
Intervention: Ceftazidime (Drug); Tobramycin (Drug); Meropenem (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Imperial College London Official(s) and/or principal investigator(s): Margaret Hodson, MD FRCP DA, Principal Investigator, Affiliation: Imperial College London
Overall contact: Andrew Jones, MB BChir MRCP, Phone: 02073518940, Email: andrew.jones1@imperial.ac.uk
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.
Clinical Details
Official title: What Duration of Intravenous Antibiotic Therapy Should be Used in the Treatment of Infective Exacerbations of Cystic Fibrosis Chronically Colonised With Pseudomonas Aeruginosa
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Treatment failure at completion of antibiotic courseTime to next exacerbation
Secondary outcome: Change in SpirometryChange in inflammatory markers Change in sputum bacteriology Adverse effects of study antibiotics Quality of life scores Change in nutritional status
Eligibility
Minimum age: 16 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Andrew Jones, MB BChir MRCP, Phone: 02073518940, Email: andrew.jones1@imperial.ac.uk
Department of Cystic Fibrosis, Royal Brompton Hospital, London Sw3 6NP, United Kingdom; Recruiting
Additional Information
Starting date: January 2010
Last updated: April 12, 2010
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