Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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
Information provided by:
Imperial College London Identifier:
First received: December 14, 2009
Last updated: April 12, 2010
Last verified: April 2010
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


Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01044719

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

Responsible Party: Prof Margaret Hodson, Imperial College London 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
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Anti-Bacterial Agents
Anti-Infective Agents processed this record on January 14, 2017