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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Antibiotic treatment for KPC producing CRE-containing gram-negative infections
Carolinas Medical Center
Charlotte, North Carolina, United States
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.
Time frame: 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.
Time frame: 30 days
Mortality
Survival at 30 days
Time frame: 30 days
90 day Mortality
Survival at 90 days
Time frame: 90 days
Adverse effects
Incidence of nephrotoxicity, leukopenia, rash, hepatotoxicity, and seizure in treatment group
Time frame: 90 days
Total Length of hospital stays
Days of hospitalization for CRE infection
Time frame: 90 days
Recurrence of infection
Recurrence of CRE-containing infection within 90 days
Time frame: 90 days
Development of resistance
If recurrent CRE infection develops following index infection treated with IMI/REL, then incidence of IMI/REL resistance in subsequent bacterial cultures
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Time frame: 90 days