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

Part of paid clinical trials in Gainesville, Florida.

Sponsor
Innoviva Specialty Therapeutics
Study ID
NCT06746883
Status
Recruiting
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Conditions

  • Acinetobacter Baumannii-calcoaceticus Complex Infection (ABC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Non-interventional — OTHER
    Non-interventional

Study Details

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.

Key Dates

Start date
Apr 28, 2025
Status verified
May 2026
Primary completion
Jan 31, 2029
Completion
Jan 31, 2029

Study Design

Enrollment
100 participants (estimated)

Arms

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

Primary Outcome Measure

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 ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
University of Florida - GainesvilleGainesvilleFlorida32610-3003-
University of Kansas Medical Center-Kansas City-3901 Rainbow BlvdKansas CityKansas66160-
University of Kentucky College of MedicineLexingtonKentucky40536-7001-
Ochsner Medical Center - New OrleansNew OrleansLouisiana70121-2429-
Ochsner LSU Health Science Center ShreveportShreveportLouisiana71103-4228-
Montefiore Medical Group Family Care CenterThe BronxNew York10467-2410-
Summa Health System - Akron - 75 Arch StreetAkronOhio44304-1430-
The Carl and Edyth Lindner Center for Research and Education at Christ HospitalCincinnatiOhio45219-
University of Pittsburg School of MedicinePittsburghPennsylvania15213-2500-
Prisma Health - Infectious Diseases - GreenvilleGreenvilleSouth Carolina29605-

Find similar trials in Gainesville, FL

By research site
University of Florida - Gainesville· Gainesville, FLUniversity of Kansas Medical Center-Kansas City-3901 Rainbow Blvd· Kansas City, KSUniversity of Kentucky College of Medicine· Lexington, KYOchsner Medical Center - New Orleans· New Orleans, LAOchsner LSU Health Science Center Shreveport· Shreveport, LAMontefiore Medical Group Family Care Center· The Bronx, NY

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