Duration of Antibiotics in Infective Exacerbations of Cystic Fibrosis
What Duration of Intravenous Antibiotic Therapy Should be Used in the Treatment of Infective Exacerbations of Cystic Fibrosis Chronically Colonised With Pseudomonas Aeruginosa
1 other identifier
interventional
240
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 14, 2009
CompletedStudy Start
First participant enrolled
January 1, 2010
CompletedFirst Posted
Study publicly available on registry
January 8, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedApril 13, 2010
April 1, 2010
9 months
December 14, 2009
April 12, 2010
Conditions
Outcome Measures
Primary Outcomes (2)
Treatment failure at completion of antibiotic course
21 days
Time to next exacerbation
6 months
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (3)
10 days
ACTIVE COMPARATOR14 days
ACTIVE COMPARATOR21 days
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- years or older
- Diagnosis of Cystic Fibrosis
- Presenting with Infective exacerbation
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Cystic Fibrosis, Royal Brompton Hospital
London, Sw3 6NP, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Margaret Hodson, MD FRCP DA
Imperial College London
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 14, 2009
First Posted
January 8, 2010
Study Start
January 1, 2010
Primary Completion
October 1, 2010
Study Completion
April 1, 2011
Last Updated
April 13, 2010
Record last verified: 2010-04