Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis
Dates
study started
study ends around

Description

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

Keywords

Acinetobacter Baumannii-calcoaceticus Complex Infection (ABC), ABC infection, Acinetobacter baumannii-calcoaceticus complex infection, Hospital-acquired bacterial pneumonia, Ventilator-associated bacterial pneumonia, Sulbactam-durlobactam, Acinetobacter, Non-interventional, Acinetobacter baumannii-calcoaceticus complex (ABC)

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • A history of significant hypersensitivity or allergic reaction to any β-lactam, or any contraindication to the use of β-lactam antibiotics

Locations

  • UC Davis Health accepting new patients
    Sacramento California 95817 United States
  • University of Kansas Medical Center-Kansas City-3901 Rainbow Blvd accepting new patients
    Kansas City Kansas 66160 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Innoviva Specialty Therapeutics
ID
NCT06746883
Study Type
Observational
Participants
Expecting 100 study participants
Last Updated