Duration of Antibiotics in Infective Exacerbations of Cystic Fibrosis

NCT ID: NCT01044719

Last Updated: 2010-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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10 days

Group Type ACTIVE_COMPARATOR

Ceftazidime

Intervention Type DRUG

Ceftazidime 2g TDS IV

Tobramycin

Intervention Type DRUG

Tobramycin 7mg/kg/day OD IV

Meropenem

Intervention Type DRUG

Meropenem 2g TDS IV

14 days

Group Type ACTIVE_COMPARATOR

Ceftazidime

Intervention Type DRUG

Ceftazidime 2g TDS IV

Tobramycin

Intervention Type DRUG

Tobramycin 7mg/kg/day OD IV

Meropenem

Intervention Type DRUG

Meropenem 2g TDS IV

21 days

Group Type ACTIVE_COMPARATOR

Ceftazidime

Intervention Type DRUG

Ceftazidime 2g TDS IV

Tobramycin

Intervention Type DRUG

Tobramycin 7mg/kg/day OD IV

Meropenem

Intervention Type DRUG

Meropenem 2g TDS IV

Interventions

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Ceftazidime

Ceftazidime 2g TDS IV

Intervention Type DRUG

Tobramycin

Tobramycin 7mg/kg/day OD IV

Intervention Type DRUG

Meropenem

Meropenem 2g TDS IV

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Imperial College London

OTHER

Sponsor Role lead

Responsible Party

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Imperial College London

Principal Investigators

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Margaret Hodson, MD FRCP DA

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

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Department of Cystic Fibrosis, Royal Brompton Hospital

London, , United Kingdom

Site Status

Countries

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United Kingdom

Central Contacts

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Andrew Jones, MB BChir MRCP

Role: CONTACT

02073518940

Other Identifiers

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RBHADS001

Identifier Type: -

Identifier Source: org_study_id

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