Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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
Query!
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
Query!
Secondary ID [1]
280047
0
ClinicalTrials.gov: NCT00891423
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Sepsis
3749
0
Query!
Condition category
Condition code
Infection
3928
3928
0
0
Query!
Studies of infection and infectious agents
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Meropenem 500mg administered as a 3 hour infusion.
Wash-out period between treatments of at least 24 hours.
Query!
Intervention code [1]
3464
0
Treatment: Drugs
Query!
Comparator / control treatment
Meropenem 1g administered as a 30 minute infusion.
Wash-out period between treatments of at least 24 hours.
Query!
Control group
Dose comparison
Query!
Outcomes
Primary outcome [1]
4825
0
Time above mean inhibitory concentration
Query!
Assessment method [1]
4825
0
Query!
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
Query!
Secondary outcome [1]
296279
0
Nil
Query!
Assessment method [1]
296279
0
Query!
Timepoint [1]
296279
0
Nil
Query!
Eligibility
Key inclusion criteria
Adult intensive care patients
Sepsis
Predicted duration of treatment more than 3 days
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
100
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Predicted duration of treatment < 3 days
Hypersensitivity to meropenem or other beta-lactams
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Crossover
Query!
Other design features
Query!
Phase
Phase 4
Query!
Type of endpoint/s
Pharmacokinetics / pharmacodynamics
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Date of first participant enrolment
Anticipated
16/05/2009
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
10
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment postcode(s) [1]
5030
0
3084
Query!
Funding & Sponsors
Funding source category [1]
3927
0
Hospital
Query!
Name [1]
3927
0
Austin Hospital
Query!
Address [1]
3927
0
Studley Road
Heidelberg
VIC 3084
Query!
Country [1]
3927
0
Australia
Query!
Primary sponsor type
Hospital
Query!
Name
Austin Hospital
Query!
Address
Studley Road
Heidelberg
VIC 3084
Query!
Country
Australia
Query!
Secondary sponsor category [1]
3521
0
None
Query!
Name [1]
3521
0
Query!
Address [1]
3521
0
Query!
Country [1]
3521
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
5993
0
Austin Health Ethics Committee
Query!
Ethics committee address [1]
5993
0
Query!
Ethics committee country [1]
5993
0
Australia
Query!
Date submitted for ethics approval [1]
5993
0
15/10/2008
Query!
Approval date [1]
5993
0
15/12/2008
Query!
Ethics approval number [1]
5993
0
H2008/03406
Query!
Summary
Brief summary
Meropenem is an antibiotic used in the treatment of serious infections. This study aims to investigate whether giving meropenem a by a longer infusion (3 hours) but a lower dose, enables the antibiotic to be in the bloodstream for at least the same amount of time as a higher dose given over a short time (30 minutes).
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
28977
0
Query!
Address
28977
0
Query!
Country
28977
0
Query!
Phone
28977
0
Query!
Fax
28977
0
Query!
Email
28977
0
Query!
Contact person for public queries
Name
12134
0
Dr Katherine Langan
Query!
Address
12134
0
Austin Hospital
Studley Road
Heidelberg
VIC 3084
Query!
Country
12134
0
Australia
Query!
Phone
12134
0
61394965000
Query!
Fax
12134
0
Query!
Email
12134
0
[email protected]
Query!
Contact person for scientific queries
Name
3062
0
Dr Katherine Langan
Query!
Address
3062
0
Austin Hospital
Studley Road
Heidelberg
VIC 3084
Query!
Country
3062
0
Australia
Query!
Phone
3062
0
61394965000
Query!
Fax
3062
0
Query!
Email
3062
0
[email protected]
Query!
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.
Download to PDF