A Study of Meropenem Standard 30 Minute Infusion Versus Prolonged 3 Hour Infusion in Intensive Care Unit (ICU) Patients

NCT00891423 | Completed

• 2 other identifiers: H2008/03406ACTRN
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis

Keywords

Meropenem; extended infusion; prolonged infusion; Time above MIC

Outcome Measures

Primary Outcomes (1)

• Time above MIC

  01/31/2010

Study Arms (2)

Meropenem short infusion

ACTIVE COMPARATOR

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

Drug: Meropenem short infusion

Meropenem extended infusion

EXPERIMENTAL

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

Drug: Meropenem extended infusion

Interventions

Meropenem short infusion DRUG

Also known as: Merrem

Meropenem short infusion

Meropenem extended infusion DRUG

Also known as: Merrem

Meropenem extended infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult intensive care patients
• Predicted duration of treatment 3 days or more

You may not qualify if:

• 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

Sponsors & Collaborators

• Austin Health: lead

Study Sites (1)

Austin Health

Melbourne, Victoria, 3084, Australia

Location

MeSH Terms

Conditions

Sepsis

Interventions

Meropenem

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thienamycins; Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Paul JOHNSON

  Austin Health

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Infectious diseases registrar

Study Record Dates

• First Submitted: April 30, 2009
• First Posted: May 1, 2009
• Study Start: April 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: August 3, 2015

Record last verified: 2015-07

Locations

AU (1)