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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

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]

ACTRN

Secondary ID [2]

H2008/03406

Universal Trial Number (UTN)

Trial acronym

MERO001

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Sepsis

Condition category

Condition code

Intervention/exposure

Study type

Interventional

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

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Time above MIC

Timepoint [1]

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

Sex

Both males and females

Can healthy volunteers participate?

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

1/04/2009

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

1/01/2010

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Austin Health - Melbourne

Recruitment postcode(s) [1]

3084 - Melbourne

Funding & Sponsors

Primary sponsor type

Government body

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/study/NCT00891423

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Paul JOHNSON

Address

Austin Health

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

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

Trial Review

Registering a new trial?

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