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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Study Type
Observational
Observational Model
Case-Only
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Acinetobacter baumannii-calcoaceticus complex (ABC) Hospitalized participants with a proven or strongly suspected ABC infection who have received sulbactam-durlobactam as standard of care.
  • Other: Non-interventional
    Non-interventional

Recruiting Locations

University of Kansas Medical Center-Kansas City-3901 Rainbow Blvd
Kansas City 4273837, Kansas 4273857 66160

More Details

Status
Recruiting
Sponsor
Innoviva Specialty Therapeutics

Study Contact

Reddy Tummala ISTX Clinical Trials
617-715-3600
Clinicaltrials@istx.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.