Clinical trial NCT06746883: A Study to Assess the Safety and Risk of Hypersensitivity Reactions of Sulbactam-durlobactam in Adults With Acinetobacter Baumannii-calcoaceticus (ABC) Complex Infection
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acinetobacter Baumannii-calcoaceticus Complex Infection (ABC)
Keywords: ABC infection
Acinetobacter baumannii-calcoaceticus complex infection
Hospital-acquired bacterial pneumonia
Ventilator-associated bacterial pneumonia
Sulbactam-durlobactam
Acinetobacter
Lead sponsor: Innoviva Specialty Therapeutics
Sponsor class: INDUSTRY
First posted: 2024-12-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hospitalized participants

Brief 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 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

Primary outcomes:
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
timeFrame: 28 days
measure: Number of participants experiencing TEAEs
timeFrame: 28 days
measure: Incidence of maximum severity level of TEAEs
timeFrame: 28 days
measure: Incidence of related TEAEs as assessed by the investigator.
timeFrame: 28 days
measure: Incidence of serious TEAEs
timeFrame: 28 days
measure: 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.
timeFrame: 28 days
measure: Number of participants experiencing AESIs
timeFrame: 28 days
measure: Incidence of maximum severity level of AESIs
timeFrame: 28 days
measure: Incidence of related AESIs as assessed by the investigator
timeFrame: 28 days
measure: Incidence of serious AESIs
timeFrame: 28 days
Secondary outcomes:
measure: Actual observed values over time of liver function tests
timeFrame: Baseline and Day 28
measure: Change from baseline values of liver function tests
timeFrame: Day 28
measure: Actual observed values over time of systolic blood pressure
timeFrame: Baseline and Day 28
measure: Change from baseline values over time of systolic blood pressure
timeFrame: Day 28
measure: Actual observed values over time of diastolic blood pressure
timeFrame: Baseline and Day 28
measure: Change from baseline values of diastolic blood pressure
timeFrame: Day 28
measure: Actual observed values over time of temperature
timeFrame: Baseline and Day 28
measure: Change from baseline values of temperature
timeFrame: Day 28
measure: Actual observed values over time of pulse rate
timeFrame: Baseline and Day 28
measure: Change from baseline values of pulse rate
timeFrame: Day 28
measure: Actual observed values over time of respiration rate
timeFrame: Baseline and Day 28
measure: Change from baseline values of respiration rate
timeFrame: Day 28
measure: Summary of observed values over time of ECG QT measurements
timeFrame: Baseline and Day 28
measure: Change from baseline values over time of ECG QT measurements
timeFrame: Day 28
measure: Summary of observed values over time of hemoglobin
timeFrame: Baseline and Day 28
measure: Change from baseline values over time of hemoglobin
timeFrame: Day 28
measure: Summary of observed values over time of white blood count
timeFrame: Baseline and Day 28
measure: Change from baseline values over time of white blood count
timeFrame: Day 28
measure: Summary of observed values over time of platelets
timeFrame: Baseline and Day 28
measure: Change from baseline values over time of platelets
timeFrame: Day 28
Other outcomes:
Locations:
city: Shreveport
country: United States
facility: Ochsner LSU Health Science Center Shreveport
state: Louisiana
city: Greenville
country: United States
facility: Prisma Health - Infectious Diseases - Greenville
state: South Carolina
Study officials:
References: