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.
Brief Title
A Study to Assess the Safety and Risk of Hypersensitivity Reactions of Sulbactam-durlobactam in Adults With Acinetobacter Baumannii-calcoaceticus (ABC) Complex Infection
Central Contacts
Central Contact Role
Contact
Central Contact Phone
617-715-3600
Central Contact Email
Clinicaltrials@istx.com
Completion Date
Completion Date Type
Estimated
Conditions
Acinetobacter Baumannii-calcoaceticus Complex Infection (ABC)
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
* 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
Inclusion 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.
* 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.
Gender
All
Gender Based
false
Keywords
ABC infection
Acinetobacter baumannii-calcoaceticus complex infection
Hospital-acquired bacterial pneumonia
Ventilator-associated bacterial pneumonia
Sulbactam-durlobactam
Acinetobacter
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT06746883
Org Class
Industry
Org Full Name
Innoviva Specialty Therapeutics
Org Study Id
CS2514-2023-003
Overall Status
Recruiting
Primary Completion Date
Primary Completion Date Type
Estimated
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
Primary Outcomes
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
Outcome Time Frame
28 days
Outcome Measure
Number of participants experiencing TEAEs
Outcome Time Frame
28 days
Outcome Measure
Incidence of maximum severity level of TEAEs
Outcome Time Frame
28 days
Outcome Measure
Incidence of related TEAEs as assessed by the investigator.
Outcome Time Frame
28 days
Outcome Measure
Incidence of serious TEAEs
Outcome Time Frame
28 days
Outcome 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.
Outcome Time Frame
28 days
Outcome Measure
Number of participants experiencing AESIs
Outcome Time Frame
28 days
Outcome Measure
Incidence of maximum severity level of AESIs
Outcome Time Frame
28 days
Outcome Measure
Incidence of related AESIs as assessed by the investigator
Outcome Time Frame
28 days
Outcome Measure
Incidence of serious AESIs
Outcome Time Frame
28 days
Secondary Outcomes
Outcome Time Frame
Baseline and Day 28
Outcome Measure
Actual observed values over time of liver function tests
Outcome Time Frame
Day 28
Outcome Measure
Change from baseline values of liver function tests
Outcome Time Frame
Baseline and Day 28
Outcome Measure
Actual observed values over time of systolic blood pressure
Outcome Time Frame
Day 28
Outcome Measure
Change from baseline values over time of systolic blood pressure
Outcome Time Frame
Baseline and Day 28
Outcome Measure
Actual observed values over time of diastolic blood pressure
Outcome Time Frame
Day 28
Outcome Measure
Change from baseline values of diastolic blood pressure
Outcome Time Frame
Baseline and Day 28
Outcome Measure
Actual observed values over time of temperature
Outcome Time Frame
Day 28
Outcome Measure
Change from baseline values of temperature
Outcome Time Frame
Baseline and Day 28
Outcome Measure
Actual observed values over time of pulse rate
Outcome Time Frame
Day 28
Outcome Measure
Change from baseline values of pulse rate
Outcome Time Frame
Baseline and Day 28
Outcome Measure
Actual observed values over time of respiration rate
Outcome Time Frame
Day 28
Outcome Measure
Change from baseline values of respiration rate
Outcome Time Frame
Baseline and Day 28
Outcome Measure
Summary of observed values over time of ECG QT measurements
Outcome Time Frame
Day 28
Outcome Measure
Change from baseline values over time of ECG QT measurements
Outcome Time Frame
Baseline and Day 28
Outcome Measure
Summary of observed values over time of hemoglobin
Outcome Time Frame
Day 28
Outcome Measure
Change from baseline values over time of hemoglobin
Outcome Time Frame
Baseline and Day 28
Outcome Measure
Summary of observed values over time of white blood count
Outcome Time Frame
Day 28
Outcome Measure
Change from baseline values over time of white blood count
Outcome Time Frame
Baseline and Day 28
Outcome Measure
Summary of observed values over time of platelets
Outcome Time Frame
Day 28
Outcome Measure
Change from baseline values over time of platelets
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Study Population
Hospitalized participants
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Paul Riska
Investigator Email
priska@montefiore.org
Investigator Phone
718-020-6494
Investigator Department
Medicine
Investigator Division
Infectious Diseases
Investigator Sponsor Organization
External
Study Department
Please Specify
Study Division
Please Specify