SepsisMERO001NCT00891423
A Study of Meropenem Standard 30 Minute Infusion Versus Prolonged 3 Hour Infusion in Intensive Care Unit (ICU) Patients
A study testing Meropenem short infusion and Meropenem extended infusion in people with Sepsis, run by Austin Health at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- Meropenem short infusion and Meropenem extended infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteAustralia
- Study dates
- Apr 2009to Jan 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult intensive care patients
- Predicted duration of treatment 3 days or more
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Controlled Crossover Pilot Study of Meropenem Standard 30 Minute Infusion Versus Prolonged 3 Hour Infusion in Intensive Care Patients
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.
Read more
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.
Read the 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.
- Conditions
- Sepsis
- Being tested
- Meropenem short infusion, Meropenem extended infusion
- Keywords
- Meropenem, extended infusion, prolonged infusion, Time above MIC
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meropenem short infusionDrug
Also called Merrem
Meropenem extended infusionDrug
Also called Merrem
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Meropenem extended infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time above MIC
Measured: 01/31/2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2009 (estimated)
- Study startApr 2009
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Austin Health
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Katherine Langan, Austin Health
- Investigators
- Paul JOHNSON, Study director, Austin Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00891423
- Sponsor's protocol ID
- H2008/03406
- Other IDs
- ACTRN
- Acronym
- MERO001
- Status last verified
- Jul 2015
- First submitted
- 30 Apr 2009
- Last updated
- 3 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Crossover Pilot Study of Meropenem Standard 30 Minute Infusion Versus Prolonged 3 Hour Infusion in Intensive Care Patients
- ClinicalTrials.gov ID
- NCT00891423
- Acronym / sponsor ID
- MERO001 / H2008/03406
- Conditions
- Sepsis
- Keywords
- Meropenem, extended infusion, prolonged infusion, Time above MIC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Austin HealthOther government
- Study start
- Apr 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 1 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meropenem short infusion | Active comparator | Drug: Meropenem short infusionMeropenem 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 |
| Meropenem extended infusion | Experimental | Drug: Meropenem extended infusionMeropenem 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult intensive care patients
- Predicted duration of treatment 3 days or more
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meropenem short infusionAlso: Merrem | Drug | Meropenem short infusion |
| Meropenem extended infusionAlso: Merrem | Drug | Meropenem extended infusion |
Primary outcome
Time above MIC
Time frame: 01/31/2010
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2015.
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Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul JOHNSON study director
Austin Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meropenem short infusion and Meropenem extended infusion in people with Sepsis, run by Austin Health at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time above MIC (time frame: 01/31/2010). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2015.