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Duration of Antibiotics in Infective Exacerbations of Cystic Fibrosis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2010 by Imperial College London.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01044719
First Posted: January 8, 2010
Last Update Posted: April 13, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Imperial College London
  Purpose
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.

Condition Intervention Phase
Cystic Fibrosis Drug: Ceftazidime Drug: Tobramycin Drug: Meropenem Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Treatment failure at completion of antibiotic course [ Time Frame: 21 days ]
  • Time to next exacerbation [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Change in Spirometry [ Time Frame: up to 21 days ]
  • Change in inflammatory markers [ Time Frame: up to 21 days ]
  • Change in sputum bacteriology [ Time Frame: up to 21 days ]
  • Adverse effects of study antibiotics [ Time Frame: Up to 21 days ]
  • Quality of life scores [ Time Frame: Up to 21 days ]
  • Change in nutritional status [ Time Frame: up to 21 days ]

Estimated Enrollment: 240
Study Start Date: January 2010
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 10 days Drug: Ceftazidime
Ceftazidime 2g TDS IV
Drug: Tobramycin
Tobramycin 7mg/kg/day OD IV
Drug: Meropenem
Meropenem 2g TDS IV
Active Comparator: 14 days Drug: Ceftazidime
Ceftazidime 2g TDS IV
Drug: Tobramycin
Tobramycin 7mg/kg/day OD IV
Drug: Meropenem
Meropenem 2g TDS IV
Active Comparator: 21 days Drug: Ceftazidime
Ceftazidime 2g TDS IV
Drug: Tobramycin
Tobramycin 7mg/kg/day OD IV
Drug: Meropenem
Meropenem 2g TDS IV

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01044719


Contacts
Contact: Andrew Jones, MB BChir MRCP 02073518940 andrew.jones1@imperial.ac.uk

Locations
United Kingdom
Department of Cystic Fibrosis, Royal Brompton Hospital Recruiting
London, United Kingdom, Sw3 6NP
Sponsors and Collaborators
Imperial College London
Investigators
Principal Investigator: Margaret Hodson, MD FRCP DA Imperial College London
  More Information

Responsible Party: Prof Margaret Hodson, Imperial College London
ClinicalTrials.gov Identifier: NCT01044719     History of Changes
Other Study ID Numbers: RBHADS001
First Submitted: December 14, 2009
First Posted: January 8, 2010
Last Update Posted: April 13, 2010
Last Verified: April 2010

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Anti-Bacterial Agents
Tobramycin
Meropenem
Ceftazidime
Anti-Infective Agents