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NCT06746883Recruiting

A Study to Assess the Safety and Risk of Hypersensitivity Reactions of Sulbactam-durlobactam in Adults With Acinetobacter Baumannii-calcoaceticus (ABC) Complex Infection

Innoviva Specialty Therapeutics

Start Date

4/28/2025

Completion Date

1/31/2029

Summary

The goal of this observational study is to evaluate the safety of sulbactam-durlobactam, as well as the risk of hypersensitivity reactions (including anaphylaxis) in participants with Acinetobacter baumannii-calcoaceticus complex infection. Participants will be followed for approximately 28 days in order to collect safety and reaction data.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Participant is ≥18 years old at the time of written informed consent and is hospitalized. * Participant has provided the written informed consent. If a participant is unable to provide written informed consent due to their medical condition, the participant's legally authorized representative may consent on behalf of the participant, or the decision can be made according to the procedure permitted by local law and institutional standard operating procedures (SOPs). * Participant has a proven or strongly suspected diagnosis of an infection caused by susceptible ABC isolates, based on investigator's clinical judgment. * Participant initiates treatment with SUL-DUR per routine clinical care. Participants who receive SUL-DUR within 24 hours prior to enrollment are also eligible to participate. The decision to treat the participant with SUL-DUR is made prior to and independently of study participation. * The participant has an expected survival of \>48 hours at the time of written informed consent. Exclusion Criteria: * A history of significant hypersensitivity or allergic reaction to any β-lactam, or any contraindication to the use of β-lactam antibiotics

Interventions

OTHER

Non-interventional

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Conditions

Acinetobacter Baumannii-calcoaceticus Complex Infection (ABC)

Locations

UC Davis Health

Sacramento, California 95817

United States

University of Florida - Gainesville

Gainesville, Florida 32610-3003

United States

Tampa General Hospital

Tampa, Florida 33606

United States

University of Kansas Medical Center-Kansas City-3901 Rainbow Blvd

Kansas City, Kansas 66160

United States

University of Kentucky College of Medicine

Lexington, Kentucky 40536-7001

United States

Ochsner Medical Center - New Orleans

New Orleans, Louisiana 70121-2429

United States

Ochsner LSU Health Science Center Shreveport

Shreveport, Louisiana 71103-4228

United States

Montefiore Medical Group Family Care Center

The Bronx, New York 10467-2410

United States

Summa Health System - Akron - 75 Arch Street

Akron, Ohio 44304-1430

United States

The Carl and Edyth Lindner Center for Research and Education at Christ Hospital

Cincinnati, Ohio 45219

United States

University of Pittsburg School of Medicine

Pittsburgh, Pennsylvania 15213-2500

United States

Prisma Health - Infectious Diseases - Greenville

Greenville, South Carolina 29605

United States