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Duration of Antibiotics in Infective Exacerbations of Cystic Fibrosis

Primary Purpose

Cystic Fibrosis

Status
Unknown status
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Ceftazidime
Tobramycin
Meropenem
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Cystic Fibrosis, Royal Brompton Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

10 days

14 days

21 days

Arm Description

Outcomes

Primary Outcome Measures

Treatment failure at completion of antibiotic course
Time to next exacerbation

Secondary Outcome Measures

Change in Spirometry
Change in inflammatory markers
Change in sputum bacteriology
Adverse effects of study antibiotics
Quality of life scores
Change in nutritional status

Full Information

First Posted
December 14, 2009
Last Updated
April 12, 2010
Sponsor
Imperial College London
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1. Study Identification

Unique Protocol Identification Number
NCT01044719
Brief Title
Duration of Antibiotics in Infective Exacerbations of Cystic Fibrosis
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 Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
October 2010 (Anticipated)
Study Completion Date
April 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Imperial College London

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
10 days
Arm Type
Active Comparator
Arm Title
14 days
Arm Type
Active Comparator
Arm Title
21 days
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Ceftazidime
Intervention Description
Ceftazidime 2g TDS IV
Intervention Type
Drug
Intervention Name(s)
Tobramycin
Intervention Description
Tobramycin 7mg/kg/day OD IV
Intervention Type
Drug
Intervention Name(s)
Meropenem
Intervention Description
Meropenem 2g TDS IV
Primary Outcome Measure Information:
Title
Treatment failure at completion of antibiotic course
Time Frame
21 days
Title
Time to next exacerbation
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in Spirometry
Time Frame
up to 21 days
Title
Change in inflammatory markers
Time Frame
up to 21 days
Title
Change in sputum bacteriology
Time Frame
up to 21 days
Title
Adverse effects of study antibiotics
Time Frame
Up to 21 days
Title
Quality of life scores
Time Frame
Up to 21 days
Title
Change in nutritional status
Time Frame
up to 21 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrew Jones, MB BChir MRCP
Phone
02073518940
Email
andrew.jones1@imperial.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret Hodson, MD FRCP DA
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cystic Fibrosis, Royal Brompton Hospital
City
London
ZIP/Postal Code
Sw3 6NP
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Duration of Antibiotics in Infective Exacerbations of Cystic Fibrosis

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