ObesityPhase 4NCT05146154
Impact of Obesity on the Pharmacokinetics of Imipenem-Relebactam in ICU Patients
A Phase 4 study testing Imipenem/Cilastatin/Relebactam 1.25g in people with Obesity and Critical Illness, run by University of Illinois Chicago at 1 site in United States.
Trial summary
This study is an open-label, multiple-dose pharmacokinetic study of imipenem-relebactam conducted in 12 non-infected, obese ICU patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Critical Illness
- What is being tested?
- Imipenem/Cilastatin/Relebactam 1.25g
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2023to 1 Jan 2024
- Phase
- Phase 4
- 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
- Age ≥18 years of age
- Admitted to the ICU
- BMI ≥40 kg/m2 and/or total body weight ≥120 kg
- Provide a signed and dated written informed consent prior to study participation
Who cannot join
- History of significant hypersensitivity reaction or intolerance to imipenem/cilastatin or carbapenem-based agents (doripenem, ertapenem, or meropenem +/- vaborbactam)
- History of seizures and/or receiving 1 or more anti-epileptic agent
- Serum creatinine ≥1.5 mg/dL
- Estimated creatinine clearance (CLCR) <60 mL/minute as determined by Cockcroft-Gault equation:
- Actively receiving antimicrobial therapy for treatment of a confirmed or suspected infection
- The subject has participated in a clinical trial and has received a drug or a new chemical entity within 30 days prior to the first dose of study medication
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- Positive serum pregnancy test (for women of childbearing potential)
- Currently breast feeding
- Has previously participated in this study
- Concomitant use of valproic acid or divalproex sodium
- Any other condition that may make the patient unsuitable for the study in the judgement of the investigator
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60612
About this study
This study is an open-label, multiple-dose pharmacokinetic study of imipenem-relebactam conducted in 12 non-infected, obese ICU patients.
- Conditions
- Obesity, Critical Illness
- Being tested
- Imipenem/Cilastatin/Relebactam 1.25g
- Medical subject headings
- Obesity, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imipenem/Cilastatin/Relebactam 1.25gDrug
Also called Recarbrio
Imipenem/cilastatin/relebactam is a combination beta-lactam/beta-lactamase inhibitor antimicrobial marketed under the brand name Recarbrio and the approved dose is 1.25g Q6h in patients with normal renal function. The individual components of this agent must be administered together and cannot be separated. Therefore, this constitutes only one intervention. Each subject will receive at least 2 doses of study drug.
| Study group | Role | What they receive |
|---|---|---|
| Pharmacokinetic cohort | Experimental | After at least 2 doses of study drug, serial blood samples will be collected from 12 non-infected, obese ICU patients to evaluate the pharmacokinetics of imipenem and relebactam in this population. Receives: Drug: Imipenem/Cilastatin/Relebactam 1.25g |
| Safety cohort | Experimental | After at least 2 doses of study drug, safety will be monitored closely during study drug dosing and through 72 hours after the last dose is administered in the same 12 non-infected, obese ICU patients from the PK arm Receives: Drug: Imipenem/Cilastatin/Relebactam 1.25g |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameters of imipenem and relebactam
Peak Plasma Concentration (Cmax)
Measured: 6 months
Pharmacokinetic parameters of imipenem and relebactam
Area under the plasma concentration versus time curve (AUC)
Measured: 6 months
Pharmacokinetic parameters of imipenem and relebactam
Total body clearance (CLt)
Measured: 6 months
Pharmacokinetic parameters of imipenem and relebactam
Apparent volume of distribution (Vd)
Measured: 6 months
Secondary outcomes (1)
Safety of imipenem and relebactam
Monitoring for adverse drug events
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study start1 Jan 2023 (estimated)
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jan 2024 (estimated)
Why it stopped: Investigator is no longer at University of Illinois
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05146154
- Sponsor's protocol ID
- 2021-1145
- Status last verified
- Nov 2024
- First submitted
- 13 Nov 2021
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Obesity on the Pharmacokinetics of Imipenem-Relebactam in ICU Patients
- ClinicalTrials.gov ID
- NCT05146154
- Acronym / sponsor ID
- 2021-1145
- Conditions
- Obesity, Critical Illness
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigator is no longer at University of Illinois
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 6 Dec 2021 (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.
This study is an open-label, multiple-dose pharmacokinetic study of imipenem-relebactam conducted in 12 non-infected, obese ICU patients.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmacokinetic cohort | Experimental | Drug: Imipenem/Cilastatin/Relebactam 1.25gAfter at least 2 doses of study drug, serial blood samples will be collected from 12 non-infected, obese ICU patients to evaluate the pharmacokinetics of imipenem and relebactam in this population. |
| Safety cohort | Experimental | Drug: Imipenem/Cilastatin/Relebactam 1.25gAfter at least 2 doses of study drug, safety will be monitored closely during study drug dosing and through 72 hours after the last dose is administered in the same 12 non-infected, obese ICU patients from the PK arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years of age
- Admitted to the ICU
- BMI ≥40 kg/m2 and/or total body weight ≥120 kg
- Provide a signed and dated written informed consent prior to study participation
Key exclusion criteria (11 listed)
- History of significant hypersensitivity reaction or intolerance to imipenem/cilastatin or carbapenem-based agents (doripenem, ertapenem, or meropenem +/- vaborbactam)
- History of seizures and/or receiving 1 or more anti-epileptic agent
- Serum creatinine ≥1.5 mg/dL
- Estimated creatinine clearance (CLCR) <60 mL/minute as determined by Cockcroft-Gault equation:
- Actively receiving antimicrobial therapy for treatment of a confirmed or suspected infection
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 |
|---|---|---|
| Imipenem/Cilastatin/Relebactam 1.25gAlso: RecarbrioImipenem/cilastatin/relebactam is a combination beta-lactam/beta-lactamase inhibitor antimicrobial marketed under the brand name Recarbrio and the approved dose is 1.25g Q6h in patients with normal renal function. The individual components of this agent must be administered together and cannot be separated. Therefore, this constitutes only one intervention. Each subject will receive at least 2 doses of study drug. | Drug | Pharmacokinetic cohort, Safety cohort |
Primary outcome
Pharmacokinetic parameters of imipenem and relebactam
Time frame: 6 months
Peak Plasma Concentration (Cmax)
Pharmacokinetic parameters of imipenem and relebactam
Time frame: 6 months
Area under the plasma concentration versus time curve (AUC)
Pharmacokinetic parameters of imipenem and relebactam
Time frame: 6 months
Total body clearance (CLt)
Pharmacokinetic parameters of imipenem and relebactam
Time frame: 6 months
Apparent volume of distribution (Vd)
1 secondary outcome
Safety of imipenem and relebactam
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Individual participant dataSharing planned: No
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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 Phase 4 study testing Imipenem/Cilastatin/Relebactam 1.25g in people with Obesity and Critical Illness, run by University of Illinois Chicago at 1 site in United States.
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 11 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: withdrawn, as of the sponsor's last update on 27 Nov 2024. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Pharmacokinetic parameters of imipenem and relebactam (time frame: 6 months). The study lists 4 primary outcomes in all. 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 27 Nov 2024.