Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000284864
Ethics application status
Approved
Date submitted
25/09/2008
Date registered
12/03/2012
Date last updated
14/03/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised controlled crossover pilot study of meropenem standard 30 minute infusion versus prolonged 3 hour infusion in intensive care patients
Scientific title
A study of intensive care patients comparing meropenem 500mg 3 hour infusion versus 1g 30 minute infusion and time above mean inhibitory concentration
Secondary ID [1] 280047 0
ClinicalTrials.gov: NCT00891423
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sepsis 3749 0
Condition category
Condition code
Infection 3928 3928 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Meropenem 500mg administered as a 3 hour infusion.
Wash-out period between treatments of at least 24 hours.
Intervention code [1] 3464 0
Treatment: Drugs
Comparator / control treatment
Meropenem 1g administered as a 30 minute infusion.
Wash-out period between treatments of at least 24 hours.
Control group
Dose comparison

Outcomes
Primary outcome [1] 4825 0
Time above mean inhibitory concentration
Timepoint [1] 4825 0
During dosing interval (from start of infusion to prior to commencement of next infusion). Eight hours if creatinine clearance equal or greater than 50 mls/min and 12 hours if less than 50 mls/min
Secondary outcome [1] 296279 0
Nil
Timepoint [1] 296279 0
Nil

Eligibility
Key inclusion criteria
Adult intensive care patients
Sepsis
Predicted duration of treatment more than 3 days
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Predicted duration of treatment < 3 days
Hypersensitivity to meropenem or other beta-lactams

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/05/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5030 0
3084

Funding & Sponsors
Funding source category [1] 3927 0
Hospital
Name [1] 3927 0
Austin Hospital
Country [1] 3927 0
Australia
Primary sponsor type
Hospital
Name
Austin Hospital
Address
Studley Road
Heidelberg
VIC 3084
Country
Australia
Secondary sponsor category [1] 3521 0
None
Name [1] 3521 0
Address [1] 3521 0
Country [1] 3521 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5993 0
Austin Health Ethics Committee
Ethics committee address [1] 5993 0
Ethics committee country [1] 5993 0
Australia
Date submitted for ethics approval [1] 5993 0
15/10/2008
Approval date [1] 5993 0
15/12/2008
Ethics approval number [1] 5993 0
H2008/03406

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28977 0
Address 28977 0
Country 28977 0
Phone 28977 0
Fax 28977 0
Email 28977 0
Contact person for public queries
Name 12134 0
Dr Katherine Langan
Address 12134 0
Austin Hospital
Studley Road
Heidelberg
VIC 3084
Country 12134 0
Australia
Phone 12134 0
61394965000
Fax 12134 0
Email 12134 0
klangan@netspace.net.au
Contact person for scientific queries
Name 3062 0
Dr Katherine Langan
Address 3062 0
Austin Hospital
Studley Road
Heidelberg
VIC 3084
Country 3062 0
Australia
Phone 3062 0
61394965000
Fax 3062 0
Email 3062 0
klangan@netspace.net.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.