A Study of Meropenem Standard 30 Minute Infusion Versus Prolonged 3 Hour Infusion in Intensive Care Unit (ICU) Patients
Information source: Austin Health
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sepsis
Intervention: Meropenem (Drug); Meropenem (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Austin Health Official(s) and/or principal investigator(s):
Benjamin Howden, BMBS, Study Director, Affiliation: Austin Health
Overall contact:
Katherine Langan, BMBS, Phone: 61394966676, Email: Katherine.LANGAN@austin.org.au
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.
Clinical Details
Official title: A Randomised Controlled Crossover Pilot Study of Meropenem Standard 30 Minute Infusion Versus Prolonged 3 Hour Infusion in Intensive Care Patients
Study design: Treatment, Randomized, Open Label, Dose Comparison, Crossover Assignment, Pharmacokinetics/Dynamics Study
Primary outcome: Time above MIC
Detailed description:
The use of pharmacodynamic and pharmacokinetic principles in antibiotic dosing is advocated
to enable more effective and efficient use of antibiotics.
The current standard of care in Austin ICU is to give meropenem 1g via short (30 min)
infusion. Small studies of healthy volunteers and intensive care patients and Monte Carlo
simulation modelling in these groups, have shown that prolonged infusions of meropenem can
provide at least equivalent T > MIC while using a smaller dose. Studies in intensive care
patients have generally excluded those with renal failure, septic shock and certain other
co-morbidities. Therefore, a study encompassing all groups of patients who receive
meropenem in the intensive care setting is required to show if these findings have more
generalised applicability.
Hypothesis/research questions:
500mg of meropenem administered as a 3 hour infusion is at least comparable to more
traditional dosing of 1 g administered as a 30 minute infusion, in attaining target time
above MIC.
We plan to compare standard meropenem therapy (1g over 30 minute infusion) with prolonged
infusion meropenem (500mg over 3 hour infusion) in a general intensive care unit. Meropenem
levels will be monitored by high performance liquid chromatography (HPLC) analysis
(Victorian College of Pharmacy) to determine pharmacokinetic and pharmacodynamic outcomes of
the different dosing regimens and will be correlated with the meropenem MIC of any
significant bacterial isolates from the patients
The outcomes of this pilot study will help plan a larger project to improve the use of
meropenem in intensive care unit patients.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Adult intensive care patients
- Predicted duration of treatment 3 days or more
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
Locations and Contacts
Katherine Langan, BMBS, Phone: 61394966676, Email: Katherine.LANGAN@austin.org.au
Austin Health, Melbourne, Victoria 3084, Australia; Recruiting
Katherine Langan, BMBS, Phone: 61394966676, Email: Katherine.LANGAN@austin.org.au
Benjamin Howden, BMBS, Phone: 61394966676, Email: benjamin.howden@austin.org.au
Katherine Langan, BMBS, Principal Investigator
Additional Information
Starting date: April 2009
Ending date: January 2010
Last updated: April 30, 2009
|
