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Duration of Antibiotics in Infective Exacerbations of Cystic Fibrosis

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ClinicalTrials.gov Identifier: NCT01044719
Recruitment Status : Unknown
Verified April 2010 by Imperial College London.
Recruitment status was:  Not yet recruiting
First Posted : January 8, 2010
Last Update Posted : April 13, 2010
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Drug: Ceftazidime Drug: Tobramycin Drug: Meropenem Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
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
Study Start Date : January 2010
Estimated Primary Completion Date : October 2010
Estimated Study Completion Date : April 2011

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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

Secondary Outcome Measures :
  1. Change in Spirometry [ Time Frame: up to 21 days ]
  2. Change in inflammatory markers [ Time Frame: up to 21 days ]
  3. Change in sputum bacteriology [ Time Frame: up to 21 days ]
  4. Adverse effects of study antibiotics [ Time Frame: Up to 21 days ]
  5. Quality of life scores [ Time Frame: Up to 21 days ]
  6. Change in nutritional status [ Time Frame: up to 21 days ]

Eligibility Criteria

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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 Posted: January 8, 2010    Key Record Dates
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
Meropenem
Tobramycin
Ceftazidime
Anti-Infective Agents