Duration of Antibiotics in Infective Exacerbations of Cystic Fibrosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Imperial College London.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT01044719
First received: December 14, 2009
Last updated: April 12, 2010
Last verified: April 2010
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
  • Time to next exacerbation [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Spirometry [ Time Frame: up to 21 days ] [ Designated as safety issue: No ]
  • Change in inflammatory markers [ Time Frame: up to 21 days ] [ Designated as safety issue: No ]
  • Change in sputum bacteriology [ Time Frame: up to 21 days ] [ Designated as safety issue: No ]
  • Adverse effects of study antibiotics [ Time Frame: Up to 21 days ] [ Designated as safety issue: Yes ]
  • Quality of life scores [ Time Frame: Up to 21 days ] [ Designated as safety issue: No ]
  • Change in nutritional status [ Time Frame: up to 21 days ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Prof Margaret Hodson, Imperial College London
ClinicalTrials.gov Identifier: NCT01044719     History of Changes
Other Study ID Numbers: RBHADS001
Study First Received: December 14, 2009
Last Updated: April 12, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on April 17, 2014