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 Therapeutics100 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Acinetobacter Baumannii-calcoaceticus Complex Infection (ABC)

Interventions

Non-interventionalOTHER

Non-interventional

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (8)

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

Kansas City, Kansas, United States

NOT_YET_RECRUITING

University of Kentucky College of Medicine

Lexington, Kentucky, United States

NOT_YET_RECRUITING

Ochsner Medical Center - New Orleans

New Orleans, Louisiana, United States

RECRUITING

Ochsner LSU Health Science Center Shreveport

Shreveport, Louisiana, United States

RECRUITING

Montefiore Medical Group Family Care Center

The Bronx, New York, United States

NOT_YET_RECRUITING

Summa Health System - Akron - 75 Arch Street

Akron, Ohio, United States

RECRUITING

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

Cincinnati, Ohio, United States

RECRUITING

Prisma Health - Infectious Diseases - Greenville

Greenville, South Carolina, United States

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

Percentage of participants experiencing Treatment Emergent Adverse Events (TEAEs) defined as any event after exposure to sulbactam-durlobactam (SUL-DUR), or event already present that worsens in either intensity or frequency after exposure

Time frame: 28 days

Number of participants experiencing TEAEs

Time frame: 28 days

Incidence of maximum severity level of TEAEs

Time frame: 28 days

Incidence of related TEAEs as assessed by the investigator.

Time frame: 28 days

Incidence of serious TEAEs

Time frame: 28 days

Percentage of participants experiencing Adverse Events of Special Interest (AESIs) defined as an AE or SAE of concern specific to the sponsor, for which ongoing monitoring is needed. AESIs include: Hypersensitivity reactions, including anaphylaxis.

Time frame: 28 days

Number of participants experiencing AESIs

Time frame: 28 days

Incidence of maximum severity level of AESIs

Time frame: 28 days

Incidence of related AESIs as assessed by the investigator

Time frame: 28 days

Incidence of serious AESIs

Time frame: 28 days