Acinetobacter Baumannii-calcoaceticus Complex Infection (ABC)
Conditions
Keywords
ABC infection, Acinetobacter baumannii-calcoaceticus complex infection, Hospital-acquired bacterial pneumonia, Ventilator-associated bacterial pneumonia, Sulbactam-durlobactam, Acinetobacter
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.
Interventions
OTHERNon-interventional
Non-interventional
Sponsors
Innoviva Specialty Therapeutics
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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 | 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 |
Countries
United States
Contacts
CONTACTReddy Tummala ISTX Clinical Trials
Outcome results
None listed