Imipenem/Cilastatin/Relebactam (IMI/REL) in Treatment of CRE Infections

NCT04785924 | Withdrawn Phase 4 FDA Drug

• 2 other identifiers: IRB00081742MISP 59805
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is an observation study comparing prospective use of Imipenem/Cilastatin/Relebactam (IMI/REL) to retrospective data using Meropenem/Vabobactam (MVB)and Ceftazidime/Avibactam CZA) in treatment of Klebsiella Producing Carbapenemase Enterobacteriaceae infections at a tertiary care hospital. The objectives of the study are to demonstrate successful treatment of KPC containing Enterobacteriaceae infections with IMI/REL including in bacteremia, and to analyze treatment outcomes in use of IMI/REL for KPC-producing infections compared to historical clinical outcome data with CZA and MVB use at the same institution.

Conditions

Carbapenem-Resistant Enterobacteriaceae Infection; KPC; Gram-Negative Bacterial Infections; Antibiotic Resistant Infection

Outcome Measures

Primary Outcomes (2)

• Clinical success

  Clinical success defined as survival at 30 days, resolution of signs and symptoms of infection, sterilization of blood cultures within 7 days of treatment initiation in patients with bacteremia, and absence of recurrent infections.

  30 days

• Clinical success by site of infection

  Clinical success in patients grouped by site of infection: bacteremia, respiratory, intra-abdominal infection, soft tissue, catheter associated and urinary tract. Subjects may be included in multiple groups if applicable for analysis.

  30 days

Secondary Outcomes (6)

• Mortality

  30 days

• 90 day Mortality

  90 days

• Adverse effects

  90 days

• Total Length of hospital stays

  90 days

• Recurrence of infection

  90 days

Study Arms (1)

Observation Treatment Group

OTHER

All patients observed while treated with IMI/REL.

Drug: Imipenem+Relebactam

Interventions

Imipenem+Relebactam DRUG

Antibiotic treatment for KPC producing CRE-containing gram-negative infections

Also known as: Recarbrio

Observation Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Bacterial infection with Enterobacteriaceae excluding Morganellaceae
• Ability and willingness to give informed consent. A Legal authorized representative may be used when the patient is unable to provide informed consent.
• Be the first episode of a CRE infection to be treated with IMI/REL. Previously treatment with IMI/REL for a KPC-containing Enterobacteriaceae infection will exclude patients from enrollment.

You may not qualify if:

• Receipt of more than 48 hours of effective antibiotic therapy against KPC containing infections (e.g. MVB, CZA) prior to first dose of IMI/REL being administered.
• Infections localized to urinary source alone (bloodstream infections from urinary source will be included)
• Infection with Morganellaceae
• Prior serious allergic reaction to carbapenem therapy
• Need for ongoing concomitant therapy with ganciclovir or valproic acid
• Need for ongoing concomitant therapy with another antibiotic active against gram negative pathogens. Concomitant therapy with Vancomycin, Daptomycin, Linezolid, Clindamycin, Fidaxomicin, Nafcillin, Metronidazole, and Rifaximin will be allowed but no other antibiotic agents.
• Pregnancy or ongoing breastfeeding. Women of childbearing age must test negative on a urine pregnancy test at time of screening for trial eligibility and remain either abstinent or use 2 forms of highly effective contraception for the duration of the IMI/REL administration during the study.
• Inability to comply with study protocol or remain hospitalized for duration of study.
• Life expectancy less than 72 hours in opinion of study investigators.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

MeSH Terms

Conditions

Gram-Negative Bacterial Infections

Interventions

imipenem, cilastatin and relebactam

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Christopher Polk, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A study of outcomes with use of an antibiotic, IMI/REL which can be compared with retrospective data of CRE-containing infections treated with MVB and CZA.

Study Record Dates

• First Submitted: March 2, 2021
• First Posted: March 8, 2021
• Study Start: June 7, 2021
• Primary Completion: January 12, 2023
• Study Completion: January 12, 2023
• Last Updated: September 4, 2024

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)