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

Recruitingn/aAges 18 Years - anyAllInnoviva Specialty Therapeutics
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Participant is โ‰ฅ18 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 ฮฒ-lactam, or any contraindication to the use of ฮฒ-lactam antibiotics
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What it tests

  • Non-interventional
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Where

12 sites
UC Davis Health
Sacramento, United States
University of Florida - Gainesville
Gainesville, United States
Tampa General Hospital
Tampa, United States
University of Kansas Medical Center-Kansas City-3901 Rainbow Blvd
Kansas City, United States
University of Kentucky College of Medicine
Lexington, United States
Ochsner Medical Center - New Orleans
New Orleans, United States
Ochsner LSU Health Science Center Shreveport
Shreveport, United States
Montefiore Medical Group Family Care Center
The Bronx, United States

โ€ฆand 4 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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