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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


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 course

Time to next exacerbation

Secondary outcome:

Change in Spirometry

Change in inflammatory markers

Change in sputum bacteriology

Adverse effects of study antibiotics

Quality of life scores

Change in nutritional status


Minimum age: 16 Years. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 23, 2015

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