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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
History of Changes

December 14, 2009
April 12, 2010
January 2010
October 2010   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01044719 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Duration of Antibiotics in Infective Exacerbations of Cystic Fibrosis
What Duration of Intravenous Antibiotic Therapy Should be Used in the Treatment of Infective Exacerbations of Cystic Fibrosis Chronically Colonised With Pseudomonas Aeruginosa

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Cystic Fibrosis
  • Drug: Ceftazidime
    Ceftazidime 2g TDS IV
  • Drug: Tobramycin
    Tobramycin 7mg/kg/day OD IV
  • Drug: Meropenem
    Meropenem 2g TDS IV
  • Active Comparator: 10 days
    Interventions:
    • Drug: Ceftazidime
    • Drug: Tobramycin
    • Drug: Meropenem
  • Active Comparator: 14 days
    Interventions:
    • Drug: Ceftazidime
    • Drug: Tobramycin
    • Drug: Meropenem
  • Active Comparator: 21 days
    Interventions:
    • Drug: Ceftazidime
    • Drug: Tobramycin
    • Drug: Meropenem
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
240
April 2011
October 2010   (final data collection date for primary outcome measure)

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
Both
16 Years and older
No
Contact: Andrew Jones, MB BChir MRCP 02073518940 andrew.jones1@imperial.ac.uk
United Kingdom
 
NCT01044719
RBHADS001
No
Prof Margaret Hodson, Imperial College London
Imperial College London
Not Provided
Principal Investigator: Margaret Hodson, MD FRCP DA Imperial College London
Imperial College London
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP