Actively Recruiting

Age: 18Years +
All Genders
NCT06746883

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

Led by Innoviva Specialty Therapeutics · Updated on 2026-02-25

100

Participants Needed

8

Research Sites

196 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participant is 18 years old or older at the time of written informed consent and is hospitalized
  • Participant has provided written informed consent or has a legally authorized representative to consent if unable
  • Participant has a proven or strongly suspected infection caused by susceptible Acinetobacter baumannii-calcoaceticus complex isolates
  • Participant initiates treatment with sulbactam-durlobactam per routine clinical care or has received it within 24 hours prior to enrollment
  • Participant has an expected survival of more than 48 hours at the time of written informed consent
Not Eligible

You will not qualify if you...

  • History of significant hypersensitivity or allergic reaction to any beta-lactam antibiotic
  • Contraindication to the use of beta-lactam antibiotics

AI-Screening

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Trial Site Locations

Total: 8 locations

1

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

Kansas City, Kansas, United States, 66160

Actively Recruiting

2

University of Kentucky College of Medicine

Lexington, Kentucky, United States, 40536-7001

Not Yet Recruiting

3

Ochsner Medical Center - New Orleans

New Orleans, Louisiana, United States, 70121-2429

Actively Recruiting

4

Ochsner LSU Health Science Center Shreveport

Shreveport, Louisiana, United States, 71103-4228

Actively Recruiting

5

Montefiore Medical Group Family Care Center

The Bronx, New York, United States, 10467-2410

Not Yet Recruiting

6

Summa Health System - Akron - 75 Arch Street

Akron, Ohio, United States, 44304-1430

Actively Recruiting

7

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

Cincinnati, Ohio, United States, 45219

Actively Recruiting

8

Prisma Health - Infectious Diseases - Greenville

Greenville, South Carolina, United States, 29605

Not Yet Recruiting

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Research Team

R

Reddy Tummala ISTX Clinical Trials

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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