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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00891423
Registration number
NCT00891423
Ethics application status
Date submitted
30/04/2009
Date registered
1/05/2009
Date last updated
3/08/2015
Titles & IDs
Public title
A Study of Meropenem Standard 30 Minute Infusion Versus Prolonged 3 Hour Infusion in Intensive Care Unit (ICU) Patients
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Scientific title
A Randomised Controlled Crossover Pilot Study of Meropenem Standard 30 Minute Infusion Versus Prolonged 3 Hour Infusion in Intensive Care Patients
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Secondary ID [1]
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ACTRN
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Secondary ID [2]
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H2008/03406
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Universal Trial Number (UTN)
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Trial acronym
MERO001
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Sepsis
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0
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Active comparator: Meropenem short infusion - Meropenem 1g infused over 30 minutes
* every 8 hours if calculated CrCL greater than or equal to 50 mL/min OR
* every 12 hours if calculated CrCL less than 50 mL/min or hemofiltration
Experimental: Meropenem extended infusion - Meropenem 500mg infused over 3 hours
* every 8 hours if calculated CrCL greater than or equal to 50 mL/min OR
* every 12 hours if calculated CrCL less than 50 mL/min or hemofiltration
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Time above MIC
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Assessment method [1]
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Timepoint [1]
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01/31/2010
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Eligibility
Key inclusion criteria
* Adult intensive care patients
* Predicted duration of treatment 3 days or more
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Predicted duration of treatment less than 3 days
* Hypersensitivity to meropenem or other beta-lactams
* Consent unable to be obtained by participant or next of kin
* Suspected or proven bacterial meningitis
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/01/2010
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Sample size
Target
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Accrual to date
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Final
10
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Austin Health - Melbourne
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Recruitment postcode(s) [1]
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3084 - Melbourne
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Funding & Sponsors
Primary sponsor type
Government body
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Name
Austin Health
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Meropenem is a powerful antibiotic used in intensive care for people who have very serious infections. Meropenem is rapidly removed from the blood by the kidneys and it is very expensive. In very ill patients in intensive care, it is uncertain how best to give this antibiotic. Studies have suggested that a smaller dose given over a longer period of time, results in blood levels of meropenem that are just as good as when a higher dose is given over a shorter period of time. This direct comparison has not been tested in intensive care patients. It is important to know this because if giving a lesser amount more slowly is just as good, then doctors will choose to give meropenem this way. To establish whether this is the case, the investigators plan to conduct an initial (pilot) study in ten intensive care patients at Austin hospital. Adult (age 18 years or older) patients in intensive care who have a serious infection being treated with the antibiotic, meropenem for three days or more will be able to participate in this study. The decision to start meropenem will be made by the intensive care doctors and they will give it in the usual way for 24 hours. The investigators will then in a random way (like tossing of a coin), give the participant meropenem either in the usual way (1 gram infused over 30 minutes) or give them a smaller amount, but over a longer period of time (500 milligrams infused over 3 hours). This will be done for 24 hours. They will then receive meropenem in the alternative way for another 24 hours. After this time the intensive care doctors will decide how meropenem will continue to be given. Blood levels of meropenem will be measured to see if they are the same when meropenem is given in each of the two different ways. During each different way of giving meropenem, 7 blood samples will need to be taken. Ten mls (or one spoonful) of blood will be required for each measurement. Blood levels will be taken through monitoring lines, which will be already present. Other information will also be collected about the participant during this study. This will include their age, gender, height, weight, information about what other medical conditions they have and measurements of how well their kidneys are functioning.
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Trial website
https://clinicaltrials.gov/study/NCT00891423
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Paul JOHNSON
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Address
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Austin Health
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
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
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00891423
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