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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00891423




Registration number
NCT00891423
Ethics application status
Date submitted
30/04/2009
Date registered
30/04/2009
Date last updated
30/07/2015

Titles & IDs
Public title
A Study of Meropenem Standard 30 Minute Infusion Versus Prolonged 3 Hour Infusion in Intensive Care Unit (ICU) Patients
Scientific title
A Randomised Controlled Crossover Pilot Study of Meropenem Standard 30 Minute Infusion Versus Prolonged 3 Hour Infusion in Intensive Care Patients
Secondary ID [1] 0 0
ACTRN
Secondary ID [2] 0 0
H2008/03406
Universal Trial Number (UTN)
Trial acronym
MERO001
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sepsis 0 0
Sepsis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Meropenem short infusion
Treatment: Drugs - Meropenem extended infusion
Treatment: Drugs - Meropenem short infusion
Treatment: Drugs - Meropenem extended infusion

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

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


Treatment: Drugs: Meropenem short infusion


Treatment: Drugs: Meropenem extended infusion


Treatment: Drugs: Meropenem short infusion


Treatment: Drugs: Meropenem extended infusion


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time above MIC
Timepoint [1] 0 0
01/31/2010
Primary outcome [2] 0 0
Time above MIC
Timepoint [2] 0 0
01/31/2010

Eligibility
Key inclusion criteria
- Adult intensive care patients

- Predicted duration of treatment 3 days or more
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

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
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Austin Health - Melbourne
Recruitment postcode(s) [1] 0 0
3084 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Austin Health
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT00891423
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Paul JOHNSON
Address 0 0
Austin Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications