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

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Kansas
University of Kansas Medical Center-Kansas City-3901 Rainbow Blvd
NOT_YET_RECRUITING
Kansas City
Kentucky
University of Kentucky College of Medicine
NOT_YET_RECRUITING
Lexington
Louisiana
Ochsner Medical Center - New Orleans
RECRUITING
New Orleans
Ochsner LSU Health Science Center Shreveport
RECRUITING
Shreveport
New York
Montefiore Medical Group Family Care Center
NOT_YET_RECRUITING
The Bronx
Ohio
Summa Health System - Akron - 75 Arch Street
RECRUITING
Akron
The Carl and Edyth Lindner Center for Research and Education at Christ Hospital
RECRUITING
Cincinnati
South Carolina
Prisma Health - Infectious Diseases - Greenville
NOT_YET_RECRUITING
Greenville
Contact Information
Primary
Reddy Tummala ISTX Clinical Trials
Clinicaltrials@istx.com
617-715-3600
Time Frame
Start Date: 2025-04-28
Estimated Completion Date: 2029-01-31
Participants
Target number of participants: 100
Treatments
Acinetobacter baumannii-calcoaceticus complex (ABC)
Hospitalized participants with a proven or strongly suspected ABC infection who have received sulbactam-durlobactam as standard of care.
Related Therapeutic Areas
Sponsors
Leads: Innoviva Specialty Therapeutics

This content was sourced from clinicaltrials.gov

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