Duration of Antibiotics in Infective Exacerbations of Cystic Fibrosis

April 12, 2010 updated by: Imperial College London

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, Sw3 6NP
        • Department of Cystic Fibrosis, Royal Brompton Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Treatment failure at completion of antibiotic course
Time Frame: 21 days
21 days
Time to next exacerbation
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Spirometry
Time Frame: up to 21 days
up to 21 days
Change in inflammatory markers
Time Frame: up to 21 days
up to 21 days
Change in sputum bacteriology
Time Frame: up to 21 days
up to 21 days
Adverse effects of study antibiotics
Time Frame: Up to 21 days
Up to 21 days
Quality of life scores
Time Frame: Up to 21 days
Up to 21 days
Change in nutritional status
Time Frame: up to 21 days
up to 21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Investigators

  • Principal Investigator: Margaret Hodson, MD FRCP DA, Imperial College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Anticipated)

October 1, 2010

Study Completion (Anticipated)

April 1, 2011

Study Registration Dates

First Submitted

December 14, 2009

First Submitted That Met QC Criteria

January 7, 2010

First Posted (Estimate)

January 8, 2010

Study Record Updates

Last Update Posted (Estimate)

April 13, 2010

Last Update Submitted That Met QC Criteria

April 12, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RBHADS001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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