Empirical Antimicrobial TherapyNCT07681544
Empirical Meropenem Dosing in Critically Ill Patients: Early Assessment of Plasma Exposure and Minimum Inhibitory Concentration Targets
A study testing Blood extraction in people with Empirical Antimicrobial Therapy and Critically Ill, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
Trial summary
The goal of this prospective cohort study is to characterize meropenem exposure in critically ill adult patients receiving empiric antibiotic treatment in the intensive care unit (ICU). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Empirical Antimicrobial Therapy, Critically Ill, Meropenem
- What is being tested?
- Blood extraction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteArgentina
- Study dates
- 26 Jun 2024to 15 Feb 2025
- 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
- Adults ≥18 years of age.
- Hospitalization in the Intensive Care Unit (ICU), Intermediate Care Unit (ICU step-down/IMCU), or Coronary Care Unit (CCU).
- Receipt of empiric meropenem therapy for at least 24 hours, regardless of the site of infection.
- Written informed consent provided by the patient or their legally authorized representative prior to study participation.
Who cannot join
- History of severe adverse reactions to meropenem.
- Availability of microbiological identification results prior to blood sampling for meropenem concentration measurement.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Meropenem Dosing in Critically Ill Patients: Early Evaluation of Plasma Concentrations and Minimum Inhibitory Concentration
The goal of this prospective cohort study is to characterize meropenem exposure in critically ill adult patients receiving empiric antibiotic treatment in the intensive care unit (ICU). Empiric treatment refers to the administration of antibiotics before the causative microorganism and its antimicrobial susceptibility profile are known. In clinical practice, meropenem is commonly administered using different dosing strategies, including 1 g or 2 g doses given as either a 30-minute or a 3-hour infusion. The minimum inhibitory concentration (MIC) is the lowest concentration of an antibiotic required to inhibit bacterial growth and is used as a reference value to evaluate antibiotic exposure. The main questions it aims to answer are:
Do meropenem plasma concentrations differ between patients receiving 1 g and those receiving 2 g, administered as either a 30-minute or a 3-hour infusion during the first 48 hours of empirical treatment in critically ill patients? Does the duration of time above the theoretical MIC of 2 mg/L differ between patients receiving meropenem 1 g and those receiving 2 g, administered as either a 30-minute or a 3-hour infusion during the first 48 hours of empirical treatment in critically ill patients?
Read more
Researchers will compare different meropenem dosing regimens (1 g versus 2 g administered as a 30-minute or a 3-hour infusion) to determine which strategy provides a longer duration of plasma concentrations above the theoretical MIC of 2 mg/L.
Participants will:
Receive meropenem as part of their standard clinical care. Have blood samples collected during the first 48 hours of treatment to measure meropenem plasma concentrations.
Have pharmacokinetic/pharmacodynamic parameters evaluated, including the percentage of time that meropenem concentrations remain above the theoretical target MIC.
An exploratory objective of the study is to describe 28-day mortality and intensive care unit length of stay according to meropenem dose group.
- Conditions
- Empirical Antimicrobial Therapy, Critically Ill, Meropenem, Pharmacokinetics and Pharmacodynamics
- Being tested
- Blood extraction
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood extractionDiagnostic test
Blood samples of 5 ml were collected within the interdose interval. Sample collection times varied among subjects, ensuring coverage of at least one sample every 30 minutes after administration of 1 g or 2 g of meropenem. After collection, samples were immediately transferred to the laboratory and stored at -80 °C until analysis.
| Study group | Role | What they receive |
|---|---|---|
| Meropenem 1 g | Experimental | Not described Receives: Diagnostic Test: Blood extraction |
| Meropenem 2 g | Experimental | Not described Receives: Diagnostic Test: Blood extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of time during the first 48 hours of meropenem therapy that plasma concentrations remain above the theoretical target MIC of 2 mg/L (%T>MIC).
Measured: During the first 48 hours of empirical treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start26 Jun 2024
- Primary completion20 Sep 2024
- Study completion15 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Empirical Antimicrobial TherapyStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Delfina Recart, Hospital Italiano de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07681544
- Sponsor's protocol ID
- 7038
- Status last verified
- Jul 2026
- First submitted
- 26 Jun 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
O'Jeanson A, Larcher R, Le Souder C, Djebli N, Khier S. Population Pharmacokinetics and Pharmacodynamics of Meropenem in Critically Ill Patients: How to Achieve Best Dosage Regimen According to the Clinical Situation. Eur J Drug Metab Pharmacokinet. 2021 Sep;46(5):695-705. doi: 10.1007/s13318-021-00709-w. Epub 2021 Aug 17.
PubMed 34403127Zhao HY, Gu J, Lyu J, Liu D, Wang YT, Liu F, Zhu FX, An YZ. Pharmacokinetic and Pharmacodynamic Efficacies of Continuous versus Intermittent Administration of Meropenem in Patients with Severe Sepsis and Septic Shock: A Prospective Randomized Pilot Study. Chin Med J (Engl). 2017 May 20;130(10):1139-1145. doi: 10.4103/0366-6999.205859.
PubMed 28485312Dulhunty JM, Roberts JA, Davis JS, Webb SA, Bellomo R, Gomersall C, Shirwadkar C, Eastwood GM, Myburgh J, Paterson DL, Lipman J. Continuous infusion of beta-lactam antibiotics in severe sepsis: a multicenter double-blind, randomized controlled trial. Clin Infect Dis. 2013 Jan;56(2):236-44. doi: 10.1093/cid/cis856. Epub 2012 Oct 16.
PubMed 23074313Kothekar AT, Divatia JV, Myatra SN, Patil A, Nookala Krishnamurthy M, Maheshwarappa HM, Siddiqui SS, Gurjar M, Biswas S, Gota V. Clinical pharmacokinetics of 3-h extended infusion of meropenem in adult patients with severe sepsis and septic shock: implications for empirical therapy against Gram-negative bacteria. Ann Intensive Care. 2020 Jan 10;10(1):4. doi: 10.1186/s13613-019-0622-8.
PubMed 31925610Mehrotra R, De Gaudio R, Palazzo M. Antibiotic pharmacokinetic and pharmacodynamic considerations in critical illness. Intensive Care Med. 2004 Dec;30(12):2145-56. doi: 10.1007/s00134-004-2428-9. Epub 2004 Nov 5.
PubMed 15536528
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meropenem Dosing in Critically Ill Patients: Early Evaluation of Plasma Concentrations and Minimum Inhibitory Concentration
- ClinicalTrials.gov ID
- NCT07681544
- Acronym / sponsor ID
- 7038
- Conditions
- Empirical Antimicrobial Therapy, Critically Ill, Meropenem, Pharmacokinetics and Pharmacodynamics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Study start
- 26 Jun 2024 (actual)
- Primary completion
- 20 Sep 2024 (actual)
- Study completion
- 15 Feb 2025 (actual)
- First posted
- 2 Jul 2026 (actual)
- 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.
The goal of this prospective cohort study is to characterize meropenem exposure in critically ill adult patients receiving empiric antibiotic treatment in the intensive care unit (ICU). Empiric treatment refers to the administration of antibiotics before the causative microorganism and its antimicrobial susceptibility profile are known. In clinical practice, meropenem is commonly administered using different dosing strategies, including 1 g or 2 g doses given as either a 30-minute or a 3-hour infusion. The minimum inhibitory concentration (MIC) is the lowest concentration of an antibiotic required to inhibit bacterial growth and is used as a reference value to evaluate antibiotic exposure. The main questions it aims to answer are:
Do meropenem plasma concentrations differ between patients receiving 1 g and those receiving 2 g, administered as either a 30-minute or a 3-hour infusion during the first 48 hours of empirical treatment in critically ill patients? Does the duration of time above the theoretical MIC of 2 mg/L differ between patients receiving meropenem 1 g and those receiving 2 g, administered as either a 30-minute or a 3-hour infusion during the first 48 hours of empirical treatment in critically ill patients?
Researchers will compare different meropenem dosing regimens (1 g versus 2 g administered as a 30-minute or a 3-hour infusion) to determine which strategy provides a longer duration of plasma concentrations above the theoretical MIC of 2 mg/L.
Participants will:
Receive meropenem as part of their standard clinical care. Have blood samples collected during the first 48 hours of treatment to measure meropenem plasma concentrations.
Have pharmacokinetic/pharmacodynamic parameters evaluated, including the percentage of time that meropenem concentrations remain above the theoretical target MIC.
An exploratory objective of the study is to describe 28-day mortality and intensive care unit length of stay according to meropenem dose group.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meropenem 1 g | Experimental | Diagnostic Test: Blood extraction |
| Meropenem 2 g | Experimental | Diagnostic Test: Blood extraction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults ≥18 years of age.
- Hospitalization in the Intensive Care Unit (ICU), Intermediate Care Unit (ICU step-down/IMCU), or Coronary Care Unit (CCU).
- Receipt of empiric meropenem therapy for at least 24 hours, regardless of the site of infection.
- Written informed consent provided by the patient or their legally authorized representative prior to study participation.
Key exclusion criteria (2 listed)
- History of severe adverse reactions to meropenem.
- Availability of microbiological identification results prior to blood sampling for meropenem concentration measurement.
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 |
|---|---|---|
| Blood extractionBlood samples of 5 ml were collected within the interdose interval. Sample collection times varied among subjects, ensuring coverage of at least one sample every 30 minutes after administration of 1 g or 2 g of meropenem. After collection, samples were immediately transferred to the laboratory and stored at -80 °C until analysis. | Diagnostic test | Meropenem 1 g, Meropenem 2 g |
Primary outcome
Percentage of time during the first 48 hours of meropenem therapy that plasma concentrations remain above the theoretical target MIC of 2 mg/L (%T>MIC).
Time frame: During the first 48 hours of empirical treatment
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 8 Jul 2026.
- Background: PubMed 34403127O'Jeanson A, Larcher R, Le Souder C, Djebli N, Khier S. Population Pharmacokinetics and Pharmacodynamics of Meropenem in Critically Ill Patients: How to Achieve Best Dosage Regimen According to the Clinical Situation. Eur J Drug Metab Pharmacokinet. 2021 Sep;46(5):695-705. doi: 10.1007/s13318-021-00709-w. Epub 2021 Aug 17.
- Background: PubMed 28485312Zhao HY, Gu J, Lyu J, Liu D, Wang YT, Liu F, Zhu FX, An YZ. Pharmacokinetic and Pharmacodynamic Efficacies of Continuous versus Intermittent Administration of Meropenem in Patients with Severe Sepsis and Septic Shock: A Prospective Randomized Pilot Study. Chin Med J (Engl). 2017 May 20;130(10):1139-1145. doi: 10.4103/0366-6999.205859.
- Background: PubMed 23074313Dulhunty JM, Roberts JA, Davis JS, Webb SA, Bellomo R, Gomersall C, Shirwadkar C, Eastwood GM, Myburgh J, Paterson DL, Lipman J. Continuous infusion of beta-lactam antibiotics in severe sepsis: a multicenter double-blind, randomized controlled trial. Clin Infect Dis. 2013 Jan;56(2):236-44. doi: 10.1093/cid/cis856. Epub 2012 Oct 16.
- Background: PubMed 31925610Kothekar AT, Divatia JV, Myatra SN, Patil A, Nookala Krishnamurthy M, Maheshwarappa HM, Siddiqui SS, Gurjar M, Biswas S, Gota V. Clinical pharmacokinetics of 3-h extended infusion of meropenem in adult patients with severe sepsis and septic shock: implications for empirical therapy against Gram-negative bacteria. Ann Intensive Care. 2020 Jan 10;10(1):4. doi: 10.1186/s13613-019-0622-8.
- Background: PubMed 15536528Mehrotra R, De Gaudio R, Palazzo M. Antibiotic pharmacokinetic and pharmacodynamic considerations in critical illness. Intensive Care Med. 2004 Dec;30(12):2145-56. doi: 10.1007/s00134-004-2428-9. Epub 2004 Nov 5.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood extraction in people with Empirical Antimicrobial Therapy and Critically Ill, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
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 4 inclusion and 2 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 8 Jul 2026. 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 Argentina. 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?
Percentage of time during the first 48 hours of meropenem therapy that plasma concentrations remain above the theoretical target MIC of 2 mg/L (%T>MIC). (time frame: During the first 48 hours of empirical treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07681544, which also lists 5 linked publications.
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 8 Jul 2026.