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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acinetobacter baumannii-calcoaceticus complex (ABC) | Hospitalized participants with a proven or strongly suspected ABC infection who have received sulbactam-durlobactam as standard of care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-interventional | Other | Non-interventional |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 28 days | |
| Number of participants experiencing TEAEs | 28 days | |
| Incidence of maximum severity level of TEAEs | 28 days | |
| Incidence of related TEAEs as assessed by the investigator. | 28 days | |
| Incidence of serious TEAEs | 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. | 28 days | |
| Number of participants experiencing AESIs | 28 days | |
| Incidence of maximum severity level of AESIs | 28 days | |
| Incidence of related AESIs as assessed by the investigator | 28 days | |
| Incidence of serious AESIs | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Actual observed values over time of liver function tests | Baseline and Day 28 | |
| Change from baseline values of liver function tests | Day 28 | |
| Actual observed values over time of systolic blood pressure |
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Inclusion Criteria:
Exclusion Criteria:
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Hospitalized participants
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reddy Tummala ISTX Clinical Trials | Contact | 617-715-3600 | Clinicaltrials@istx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Davis Health | Recruiting | Sacramento | California | 95817 | United States | |
| University of Florida - Gainesville |
All collected de-identified IPD may be shared
Data requests may be submitted starting 6 months after primary article publication and the data will be made accessible for up to 24 months; extensions may be considered on a case-by-case basis.
Subject to certain criteria, conditions, and exceptions and upon completion of the review and approval of the Research Proposal and Statistical Analysis Plan, Qualified Researchers engaging in independent scientific research can be provided de-identified IPD following the execution of a Data Sharing Agreement.
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| Baseline and Day 28 |
| Change from baseline values over time of systolic blood pressure | Day 28 |
| Actual observed values over time of diastolic blood pressure | Baseline and Day 28 |
| Change from baseline values of diastolic blood pressure | Day 28 |
| Actual observed values over time of temperature | Baseline and Day 28 |
| Change from baseline values of temperature | Day 28 |
| Actual observed values over time of pulse rate | Baseline and Day 28 |
| Change from baseline values of pulse rate | Day 28 |
| Actual observed values over time of respiration rate | Baseline and Day 28 |
| Change from baseline values of respiration rate | Day 28 |
| Summary of observed values over time of ECG QT measurements | Baseline and Day 28 |
| Change from baseline values over time of ECG QT measurements | Day 28 |
| Summary of observed values over time of hemoglobin | Baseline and Day 28 |
| Change from baseline values over time of hemoglobin | Day 28 |
| Summary of observed values over time of white blood count | Baseline and Day 28 |
| Change from baseline values over time of white blood count | Day 28 |
| Summary of observed values over time of platelets | Baseline and Day 28 |
| Change from baseline values over time of platelets | Day 28 |
| Recruiting |
| Gainesville |
| Florida |
| 32610-3003 |
| United States |
| Tampa General Hospital | Recruiting | Tampa | Florida | 33606 | United States |
| University of Kansas Medical Center-Kansas City-3901 Rainbow Blvd | Recruiting | Kansas City | Kansas | 66160 | United States |
| University of Kentucky College of Medicine | Recruiting | Lexington | Kentucky | 40536-7001 | United States |
| Ochsner Medical Center - New Orleans | Recruiting | New Orleans | Louisiana | 70121-2429 | United States |
| Ochsner LSU Health Science Center Shreveport | Recruiting | Shreveport | Louisiana | 71103-4228 | United States |
| Montefiore Medical Group Family Care Center | Recruiting | The Bronx | New York | 10467-2410 | United States |
| Summa Health System - Akron - 75 Arch Street | Recruiting | Akron | Ohio | 44304-1430 | United States |
| The Carl and Edyth Lindner Center for Research and Education at Christ Hospital | Recruiting | Cincinnati | Ohio | 45219 | United States |
| University of Pittsburg School of Medicine | Recruiting | Pittsburgh | Pennsylvania | 15213-2500 | United States |
| Prisma Health - Infectious Diseases - Greenville | Recruiting | Greenville | South Carolina | 29605 | United States |