Non-Interventional
OtherNon-interventional
Recruiting
NCT Number: NCT06746883
A Study to Assess the Safety and Risk of Hypersensitivity Reactions of Sulbactam-durlobactam in Adults With Acinetobacter Baumannii-calcoaceticus (ABC) Complex Infection
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.
Recruiting
Interested in participating?
Request InfoKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
UC Davis Health, Sacramento, California, United States
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Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
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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
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Number of participants experiencing TEAEs
Time frame: 28 days
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Incidence of maximum severity level of TEAEs
Time frame: 28 days
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Incidence of related TEAEs as assessed by the investigator.
Time frame: 28 days
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Incidence of serious TEAEs
Time frame: 28 days
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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
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Number of participants experiencing AESIs
Time frame: 28 days
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Incidence of maximum severity level of AESIs
Time frame: 28 days
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Incidence of related AESIs as assessed by the investigator
Time frame: 28 days
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Incidence of serious AESIs
Time frame: 28 days
Secondary outcomes
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Actual observed values over time of liver function tests
Time frame: Baseline and Day 28
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Change from baseline values of liver function tests
Time frame: Day 28
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Actual observed values over time of systolic blood pressure
Time frame: Baseline and Day 28
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Change from baseline values over time of systolic blood pressure
Time frame: Day 28
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Actual observed values over time of diastolic blood pressure
Time frame: Baseline and Day 28
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Change from baseline values of diastolic blood pressure
Time frame: Day 28
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Actual observed values over time of temperature
Time frame: Baseline and Day 28
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Change from baseline values of temperature
Time frame: Day 28
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Actual observed values over time of pulse rate
Time frame: Baseline and Day 28
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Change from baseline values of pulse rate
Time frame: Day 28
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Actual observed values over time of respiration rate
Time frame: Baseline and Day 28
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Change from baseline values of respiration rate
Time frame: Day 28
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Summary of observed values over time of ECG QT measurements
Time frame: Baseline and Day 28
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Change from baseline values over time of ECG QT measurements
Time frame: Day 28
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Summary of observed values over time of hemoglobin
Time frame: Baseline and Day 28
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Change from baseline values over time of hemoglobin
Time frame: Day 28
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Summary of observed values over time of white blood count
Time frame: Baseline and Day 28
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Change from baseline values over time of white blood count
Time frame: Day 28
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Summary of observed values over time of platelets
Time frame: Baseline and Day 28
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Change from baseline values over time of platelets
Time frame: Day 28
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Innoviva Specialty Therapeutics
Industry
Registry information
Official study 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
Important dates
- Study start
- 2025
- Primary completion
- 2029
- Study completion
- 2029
- First posted
- Dec 24, 2024
- Registry last updated
- Jun 24, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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