Critical IllnessNCT03858387
PK/PD and Clinial Outcomes of Beta-lactams in ICU Patients
An observational study of Critical Illness and Bacterial Infections, run by Prince of Songkla University at 1 site in Thailand.
Trial summary
Meropenem and imipenem are broad-spectrum carbapenem antibiotic and are frequently prescribed in critically ill patients with severe infections. These patients show several pathophysiological changes that may alter the carbapenem pharmacokinetic (PK) normally found in other populations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Bacterial Infections
- What is being tested?
- Meropenem and Imipenem
- How many people
- 102 participants
- Where
- 1 siteThailand
- Study dates
- 1 Sep 2018to 31 Dec 2021
- Phase
- Observational
- 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
Study population: Critically ill patients
Who may be able to join
- age >18 years
- severely ill patient who admitted to medical or surgical intensive care unit who require a treatment with meropenem or imipenem antibiotic
Who cannot join
- severe renal impairment and require renal replacement therapy
- APACHE II score >30
- History of hypersensitivity to carbapenems
- Pregnancy or breast-feeding female
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Faculty of Medicine, Prince of Songkla University, Thailand
Hat Yai, Changwat Songkhla, 90110
Sutep Jaruratanasirikul, M.D., 6674-451485, jasutep@medicine.psu.ac.th
Monchana Nawakitrangsan, M.Pharm, 6674-451486, nana_jittung@hotmail.com
About this study
Official title: Pharmacokinetics/Pharmacodynamics and Clinical Outcomes of β-lactams in Critically Ill Patients
Meropenem and imipenem are broad-spectrum carbapenem antibiotic and are frequently prescribed in critically ill patients with severe infections. These patients show several pathophysiological changes that may alter the carbapenem pharmacokinetic (PK) normally found in other populations. Although the PK of carbapenems has been widely studied, most studies have been conducted on small populations, and clinical outcome data are sparse. Therefore, the aims of this study are (i) describe the population pharmacokinetic parameters of meropenem and imipenem in critically ill subject (ii) evaluate the pharmacodynamic of meropenem and imipenem as a predictor of clinical treatment outcome.
- Conditions
- Critical Illness, Bacterial Infections
- Being tested
- Meropenem, Imipenem
- Keywords
- pharmacokinetics, pharmacodynamics, meropenem, imipenem
- Medical subject headings
- Critical Illness, Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeropenemDrug
This group is composed of 52 critically ill patients, meropenem dosage is chosen by the intensivist in charge of the case.
Blood sampling: 5 blood samples (3 mL) were obtained from a heparinized intravascular catheter by direct venipuncture at the following time: before (time 0) and during 0-0.5 h, 0.5-2.5 h, 2.5-4 h, 4-8 h or 4-12 after meropenem administration.
ImipenemDrug
Also called Imipenem/cilastatin
This group is composed of 50 critically ill patients, imipenem dosage is chosen by the intensivist in charge of the case.
Blood sampling: 5 blood samples (3 mL) were obtained from a heparinized intravascular catheter by direct venipuncture at the following time: before (time 0) and during 0-0.5 h, 0.5-2 h, 2-4 h, 4-6 h or 4-12 after imipenem administration.
| Study group | Role | What they receive |
|---|---|---|
| Meropenem | Critically ill patients who require meropenem therapy Receives: Drug: Meropenem | |
| Imipenem | Critically ill patients who require imipenem therapy Receives: Drug: Imipenem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Population pharmacokinetic parameters of meropenem and imipenem
Measured: 24-48 hours after treatment
%fT>MIC of meropenem and imipenem
the percentage of time which the free drug concentration remains above the minimum inbibitory concentration (%fT>MIC)
Measured: 24-48 hours after treatment
Secondary outcomes (3)
The relationship between %fT>MIC and clinical cure
Clinical cure: disappearance of all signs and symptoms related to the infection, such that no additional antibacterial therapy, drainage, or surgical procedure was required.
Measured: Day 3-7 after treatment and end of therapy (7-14)
The relationship between %fT>MIC and microbiological cure
Success is eradication (absence of the baseline pathogen in a specimen appropriately obtained from the original site of infection) or presumed eradication (absence of material to culture in a subject who was assessed as a clinical cure).
Measured: Day 3-7 after treatment and end of therapy (7-14)
The relationship between %fT>MIC and mortality
All-cause mortality
Measured: during hospital stay and at day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2019
- Study start1 Sep 2018
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sutep Jaruratanasirikul, Prince of Songkla University
- Investigators
- Sutep Jaruratanasirikul, M.D., Principal investigator, Faculty of Medicine, Prince of Songkla University, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03858387
- Sponsor's protocol ID
- B-lactams-ICU-61061141
- Status last verified
- Apr 2020
- First submitted
- 24 Feb 2019
- Last updated
- 1 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jaruratanasirikul S, Boonpeng A, Nawakitrangsan M, Samaeng M. NONMEM population pharmacokinetics and Monte Carlo dosing simulations of imipenem in critically ill patients with life-threatening severe infections during support with or without extracorporeal membrane oxygenation in an intensive care unit. Pharmacotherapy. 2021 Jul;41(7):572-597. doi: 10.1002/phar.2597. Epub 2021 Jun 18.
PubMed 34080708
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics/Pharmacodynamics and Clinical Outcomes of β-lactams in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT03858387
- Acronym / sponsor ID
- B-lactams-ICU-61061141
- Conditions
- Critical Illness, Bacterial Infections
- Keywords
- pharmacokinetics, pharmacodynamics, meropenem, imipenem
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 28 Feb 2019 (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.
Meropenem and imipenem are broad-spectrum carbapenem antibiotic and are frequently prescribed in critically ill patients with severe infections. These patients show several pathophysiological changes that may alter the carbapenem pharmacokinetic (PK) normally found in other populations. Although the PK of carbapenems has been widely studied, most studies have been conducted on small populations, and clinical outcome data are sparse. Therefore, the aims of this study are (i) describe the population pharmacokinetic parameters of meropenem and imipenem in critically ill subject (ii) evaluate the pharmacodynamic of meropenem and imipenem as a predictor of clinical treatment outcome.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meropenem | – | Drug: MeropenemCritically ill patients who require meropenem therapy |
| Imipenem | – | Drug: ImipenemCritically ill patients who require imipenem therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients
Key inclusion criteria (2 listed)
- age >18 years
- severely ill patient who admitted to medical or surgical intensive care unit who require a treatment with meropenem or imipenem antibiotic
Key exclusion criteria (4 listed)
- severe renal impairment and require renal replacement therapy
- APACHE II score >30
- History of hypersensitivity to carbapenems
- Pregnancy or breast-feeding female
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 |
|---|---|---|
| MeropenemThis group is composed of 52 critically ill patients, meropenem dosage is chosen by the intensivist in charge of the case. Blood sampling: 5 blood samples (3 mL) were obtained from a heparinized intravascular catheter by direct venipuncture at the following time: before (time 0) and during 0-0.5 h, 0.5-2.5 h, 2.5-4 h, 4-8 h or 4-12 after meropenem administration. | Drug | Meropenem |
| ImipenemAlso: Imipenem/cilastatinThis group is composed of 50 critically ill patients, imipenem dosage is chosen by the intensivist in charge of the case. Blood sampling: 5 blood samples (3 mL) were obtained from a heparinized intravascular catheter by direct venipuncture at the following time: before (time 0) and during 0-0.5 h, 0.5-2 h, 2-4 h, 4-6 h or 4-12 after imipenem administration. | Drug | Imipenem |
Primary outcome
Population pharmacokinetic parameters of meropenem and imipenem
Time frame: 24-48 hours after treatment
%fT>MIC of meropenem and imipenem
Time frame: 24-48 hours after treatment
the percentage of time which the free drug concentration remains above the minimum inbibitory concentration (%fT>MIC)
3 secondary outcomes
The relationship between %fT>MIC and clinical cure
Time frame: Day 3-7 after treatment and end of therapy (7-14)
The relationship between %fT>MIC and microbiological cure
Time frame: Day 3-7 after treatment and end of therapy (7-14)
The relationship between %fT>MIC and mortality
Time frame: during hospital stay and at day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2020.
- Derived from this study: PubMed 34080708Jaruratanasirikul S, Boonpeng A, Nawakitrangsan M, Samaeng M. NONMEM population pharmacokinetics and Monte Carlo dosing simulations of imipenem in critically ill patients with life-threatening severe infections during support with or without extracorporeal membrane oxygenation in an intensive care unit. Pharmacotherapy. 2021 Jul;41(7):572-597. doi: 10.1002/phar.2597. Epub 2021 Jun 18.
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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.
Sutep Jaruratanasirikul, M.D. principal investigator
Faculty of Medicine, Prince of Songkla University, Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Bacterial Infections, run by Prince of Songkla University at 1 site in Thailand.
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: status not confirmed, as of the sponsor's last update on 1 May 2020. 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 Thailand. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sutep o Jaruratanasirikul, M.D. (6674451485 ext. 6674451485, jasutep@medicine.psu.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Population pharmacokinetic parameters of meropenem and imipenem (time frame: 24-48 hours after treatment). The study lists 2 primary outcomes in all. 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 NCT03858387, which also lists 1 linked publication.
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 1 May 2020.