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Note: This record shows only the 20 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.
Register: ClinicalTrials.gov
Last refreshed on: 17 October 2012
Main ID:  NCT01044719
Date of registration: 14/12/2009
Primary sponsor: Imperial College London
Public title: Duration of Antibiotics in Infective Exacerbations of Cystic Fibrosis
Scientific title: What Duration of Intravenous Antibiotic Therapy Should be Used in the Treatment of Infective Exacerbations of Cystic Fibrosis Chronically Colonised With Pseudomonas Aeruginosa
Date of first enrolment: January 2010
Target sample size: 240
Recruitment status: Not yet recruiting
URL:  http://clinicaltrials.gov/show/NCT01044719
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment  
Countries of recruitment
Contacts
Key inclusion & exclusion 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



Age minimum: 16 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Cystic Fibrosis
Intervention(s)
Drug: Ceftazidime
Drug: Meropenem
Drug: Tobramycin
Primary Outcome(s)
Time to next exacerbation [Time Frame: 6 months]
Treatment failure at completion of antibiotic course [Time Frame: 21 days]
Secondary Outcome(s)
Adverse effects of study antibiotics [Time Frame: Up to 21 days]
Change in inflammatory markers [Time Frame: up to 21 days]
Change in nutritional status [Time Frame: up to 21 days]
Change in Spirometry [Time Frame: up to 21 days]
Change in sputum bacteriology [Time Frame: up to 21 days]
Quality of life scores [Time Frame: Up to 21 days]
Secondary ID(s)
RBHADS001
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
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