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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01044719 |
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Date of registration:
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14/12/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Duration of Antibiotics in Infective Exacerbations of Cystic Fibrosis
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Scientific title:
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What Duration of Intravenous Antibiotic Therapy Should be Used in the Treatment of Infective Exacerbations of Cystic Fibrosis Chronically Colonised With Pseudomonas Aeruginosa |
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Date of first enrolment:
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January 2010 |
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Target sample size:
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240 |
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Recruitment status: |
Not yet recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01044719 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Margaret Hodson, MD FRCP DA |
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Address:
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Telephone:
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Email:
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Affiliation:
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Imperial College London |
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Name:
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Andrew Jones, MB BChir MRCP |
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Address:
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Telephone:
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02073518940 |
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Email:
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andrew.jones1@imperial.ac.uk |
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Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
16 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cystic Fibrosis
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Intervention(s)
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Drug: Ceftazidime
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Drug: Meropenem
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Drug: Tobramycin
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Primary Outcome(s)
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Time to next exacerbation
[Time Frame: 6 months]
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Treatment failure at completion of antibiotic course
[Time Frame: 21 days]
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Secondary Outcome(s)
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Change in sputum bacteriology
[Time Frame: up to 21 days]
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Adverse effects of study antibiotics
[Time Frame: Up to 21 days]
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Quality of life scores
[Time Frame: Up to 21 days]
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Change in nutritional status
[Time Frame: up to 21 days]
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Change in inflammatory markers
[Time Frame: up to 21 days]
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Change in Spirometry
[Time Frame: up to 21 days]
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Secondary ID(s)
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RBHADS001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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