Duration of Antibiotics in Infective Exacerbations of Cys... | NCT01044719

Studies
Duration of Antibiotics in Infective Exacerbations of Cystic Fibrosis

NCT01044719

Sponsor

Imperial College London

Status

Unknown status

Last Update Posted

Apr 13, 2010Estimated

Enrollment

240Estimated

Phase

Phase 4

Conditions

Cystic Fibrosis

Interventions

Ceftazidime
Tobramycin
Meropenem

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Oct 2010Estimated

Completion Date

Apr 2011Estimated

First Submitted Date

Dec 14, 2009

First Submission Date that Met QC Criteria

Jan 7, 2010

First Posted Date

Jan 8, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 12, 2010

Last Update Posted Date

Apr 13, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

240Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
10 days	Active Comparator	Drug: Ceftazidime Drug: Tobramycin Drug: Meropenem
14 days	Active Comparator	Drug: Ceftazidime Drug: Tobramycin Drug: Meropenem
21 days	Active Comparator	Drug: Ceftazidime Drug: Tobramycin Drug: Meropenem

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ceftazidime	Drug	Ceftazidime 2g TDS IV	10 days 14 days 21 days

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Change in Spirometry		up to 21 days
Change in inflammatory markers		up to 21 days
Change in sputum bacteriology

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Andrew Jones, MB BChir MRCP	Contact	02073518940		andrew.jones1@imperial.ac.uk

Overall Officials

Name	Affiliation	Role
Margaret Hodson, MD FRCP DA	Imperial College London	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Cystic Fibrosis, Royal Brompton Hospital		London		Sw3 6NP	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D003550	Cystic Fibrosis

Ancestor Terms

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002442	Ceftazidime
D014031	Tobramycin
D000077731	Meropenem

Ancestor Terms

ID	Term
D002509	Cephaloridine
D002511	Cephalosporins
D047090	beta-Lactams
D007769	Lactams

Browse Leaves

Not provided

Browse Branches

Not provided