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RECRUITING
NCT06746883

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

Sponsor: Innoviva Specialty Therapeutics

View on ClinicalTrials.gov

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.

Official title: A Single-arm, Open-label, Prospective, Observational Study to Assess the Safety of Sulbactam-durlobactam, Including the Risk of Hypersensitivity Reactions (Including Anaphylaxis) in Participants With Acinetobacter Baumannii-calcoaceticus Complex Infection

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2025-04-28

Completion Date

2029-01-31

Last Updated

2026-02-25

Healthy Volunteers

No

Interventions

OTHER

Non-interventional

Non-interventional

Locations (8)

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

Kansas City, Kansas, United States

University of Kentucky College of Medicine

Lexington, Kentucky, United States

Ochsner Medical Center - New Orleans

New Orleans, Louisiana, United States

Ochsner LSU Health Science Center Shreveport

Shreveport, Louisiana, United States

Montefiore Medical Group Family Care Center

The Bronx, New York, United States

Summa Health System - Akron - 75 Arch Street

Akron, Ohio, United States

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

Cincinnati, Ohio, United States

Prisma Health - Infectious Diseases - Greenville

Greenville, South Carolina, United States