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Recruiting NCT06746883

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

— Observational Acinetobacter Baumannii-calcoaceticus Complex Infection (ABC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Non-interventional.
Who it may be relevant to
Registry conditions: Acinetobacter Baumannii-calcoaceticus Complex Infection (ABC). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Other Non-interventional
    Non-interventional

Primary outcome measures

  • 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]
  • Number of participants experiencing TEAEs [Time frame: 28 days]
  • Incidence of maximum severity level of TEAEs [Time frame: 28 days]
  • Incidence of related TEAEs as assessed by the investigator. [Time frame: 28 days]
  • Incidence of serious TEAEs [Time frame: 28 days]
  • Percentage of participants experiencing Adverse Events of Special Interest (AESIs) defined as an AE or SAE of concern specific to the sponsor, for which ongoing monitoring is needed. AESIs include: Hypersensitivity reactions, including anaphylaxis. [Time frame: 28 days]
  • Number of participants experiencing AESIs [Time frame: 28 days]
  • Incidence of maximum severity level of AESIs [Time frame: 28 days]
  • Incidence of related AESIs as assessed by the investigator [Time frame: 28 days]
  • Incidence of serious AESIs [Time frame: 28 days]
Secondary outcome measures (12)
  • Actual observed values over time of liver function tests [Time frame: Baseline and Day 28]
  • Change from baseline values of liver function tests [Time frame: Day 28]
  • Actual observed values over time of systolic blood pressure [Time frame: Baseline and Day 28]
  • Change from baseline values over time of systolic blood pressure [Time frame: Day 28]
  • Actual observed values over time of diastolic blood pressure [Time frame: Baseline and Day 28]
  • Change from baseline values of diastolic blood pressure [Time frame: Day 28]
  • Actual observed values over time of temperature [Time frame: Baseline and Day 28]
  • Change from baseline values of temperature [Time frame: Day 28]
  • Actual observed values over time of pulse rate [Time frame: Baseline and Day 28]
  • Change from baseline values of pulse rate [Time frame: Day 28]
  • Actual observed values over time of respiration rate [Time frame: Baseline and Day 28]
  • Change from baseline values of respiration rate [Time frame: Day 28]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

United States · 12 centers
  • UC Davis Health — Sacramento
  • University of Florida - Gainesville — Gainesville
  • Tampa General Hospital — Tampa
  • University of Kansas Medical Center-Kansas City-3901 Rainbow Blvd — Kansas City
  • University of Kentucky College of Medicine — Lexington
  • Ochsner Medical Center - New Orleans — New Orleans
  • Ochsner LSU Health Science Center Shreveport — Shreveport
  • Montefiore Medical Group Family Care Center — The Bronx
  • … and 4 more centers

Identifiers

NCT: NCT06746883 · CS2514-2023-003

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗