Acinetobacter Baumannii-calcoaceticus Complex Infection (ABC)NCT06746883
A Study to Assess the Safety and Risk of Hypersensitivity Reactions of Sulbactam-durlobactam in Adults With Acinetobacter Baumannii-calcoaceticus (ABC) Complex Infection
An observational study of Acinetobacter Baumannii-calcoaceticus Complex Infection (ABC), run by Innoviva Specialty Therapeutics at 12 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acinetobacter Baumannii-calcoaceticus Complex Infection (ABC)
- What is being tested?
- Non-interventional
- How many people
- 100 participants
- Where
- 12 sitesUnited States
- Study dates
- 28 Apr 2025to 31 Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalized participants
Who may be able to join
- 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.
Who cannot join
- A history of significant hypersensitivity or allergic reaction to any β-lactam, or any contraindication to the use of β-lactam antibiotics
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
United States12 sites, 12 recruiting
- Recruiting
Summa Health System - Akron - 75 Arch Street
Akron, Ohio, 44304-1430
- Recruiting
The Carl and Edyth Lindner Center for Research and Education at Christ Hospital
Cincinnati, Ohio, 45219
- Recruiting
University of Florida - Gainesville
Gainesville, Florida, 32610-3003
- Recruiting
Prisma Health - Infectious Diseases - Greenville
Greenville, South Carolina, 29605
- Recruiting
University of Kansas Medical Center-Kansas City-3901 Rainbow Blvd
Kansas City, Kansas, 66160
- Recruiting
University of Kentucky College of Medicine
Lexington, Kentucky, 40536-7001
- Recruiting
Ochsner Medical Center - New Orleans
New Orleans, Louisiana, 70121-2429
- Recruiting
University of Pittsburg School of Medicine
Pittsburgh, Pennsylvania, 15213-2500
- Recruiting
UC Davis Health
Sacramento, California, 95817
- Recruiting
Ochsner LSU Health Science Center Shreveport
Shreveport, Louisiana, 71103-4228
- Recruiting
Tampa General Hospital
Tampa, Florida, 33606
- Recruiting
Montefiore Medical Group Family Care Center
The Bronx, New York, 10467-2410
About this study
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
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.
- Being tested
- Non-interventional
- Keywords
- ABC infection, Acinetobacter baumannii-calcoaceticus complex infection, Hospital-acquired bacterial pneumonia, Ventilator-associated bacterial pneumonia, Sulbactam-durlobactam, Acinetobacter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-interventionalOther
Non-interventional
| Study group | Role | What they receive |
|---|---|---|
| Acinetobacter baumannii-calcoaceticus complex (ABC) | Hospitalized participants with a proven or strongly suspected ABC infection who have received sulbactam-durlobactam as standard of care. Receives: Other: Non-interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 28 days
Number of participants experiencing TEAEs
Measured: 28 days
Incidence of maximum severity level of TEAEs
Measured: 28 days
Incidence of related TEAEs as assessed by the investigator.
Measured: 28 days
Incidence of serious TEAEs
Measured: 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.
Measured: 28 days
Number of participants experiencing AESIs
Measured: 28 days
Incidence of maximum severity level of AESIs
Measured: 28 days
Incidence of related AESIs as assessed by the investigator
Measured: 28 days
Incidence of serious AESIs
Measured: 28 days
Secondary outcomes (20)
Actual observed values over time of liver function tests
Measured: Baseline and Day 28
Change from baseline values of liver function tests
Measured: Day 28
Actual observed values over time of systolic blood pressure
Measured: Baseline and Day 28
Change from baseline values over time of systolic blood pressure
Measured: Day 28
Actual observed values over time of diastolic blood pressure
Measured: Baseline and Day 28
Change from baseline values of diastolic blood pressure
Measured: Day 28
Actual observed values over time of temperature
Measured: Baseline and Day 28
Change from baseline values of temperature
Measured: Day 28
Actual observed values over time of pulse rate
Measured: Baseline and Day 28
Change from baseline values of pulse rate
Measured: Day 28
Actual observed values over time of respiration rate
Measured: Baseline and Day 28
Change from baseline values of respiration rate
Measured: Day 28
Summary of observed values over time of ECG QT measurements
Measured: Baseline and Day 28
Change from baseline values over time of ECG QT measurements
Measured: Day 28
Summary of observed values over time of hemoglobin
Measured: Baseline and Day 28
Change from baseline values over time of hemoglobin
Measured: Day 28
Summary of observed values over time of white blood count
Measured: Baseline and Day 28
Change from baseline values over time of white blood count
Measured: Day 28
Summary of observed values over time of platelets
Measured: Baseline and Day 28
Change from baseline values over time of platelets
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start28 Apr 2025
- Primary completion31 Jan 2029 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acinetobacter Baumannii-calcoaceticus Complex Infection (ABC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innoviva Specialty Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06746883
- Sponsor's protocol ID
- CS2514-2023-003
- Status last verified
- Jun 2026
- First submitted
- 18 Dec 2024
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: All collected de-identified IPD may be shared
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06746883
- Acronym / sponsor ID
- CS2514-2023-003
- Keywords
- ABC infection, Acinetobacter baumannii-calcoaceticus complex infection, Hospital-acquired bacterial pneumonia, Ventilator-associated bacterial pneumonia, Sulbactam-durlobactam, Acinetobacter
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Innoviva Specialty TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 28 Apr 2025 (actual)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 24 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acinetobacter baumannii-calcoaceticus complex (ABC) | – | Other: Non-interventionalHospitalized participants with a proven or strongly suspected ABC infection who have received sulbactam-durlobactam as standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized participants
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- A history of significant hypersensitivity or allergic reaction to any β-lactam, or any contraindication to the use of β-lactam antibiotics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-interventionalNon-interventional | Other | Acinetobacter baumannii-calcoaceticus complex (ABC) |
Primary outcome
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
Number of participants experiencing TEAEs
Time frame: 28 days
Incidence of maximum severity level of TEAEs
Time frame: 28 days
Incidence of related TEAEs as assessed by the investigator.
Time frame: 28 days
Incidence of serious TEAEs
Time frame: 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.
Time frame: 28 days
Number of participants experiencing AESIs
Time frame: 28 days
Incidence of maximum severity level of AESIs
Time frame: 28 days
Incidence of related AESIs as assessed by the investigator
Time frame: 28 days
Incidence of serious AESIs
Time frame: 28 days
20 secondary outcomes
Actual observed values over time of liver function tests
Time frame: Baseline and Day 28
Change from baseline values of liver function tests
Time frame: Day 28
Actual observed values over time of systolic blood pressure
Time frame: Baseline and Day 28
Change from baseline values over time of systolic blood pressure
Time frame: Day 28
Actual observed values over time of diastolic blood pressure
Time frame: Baseline and Day 28
Change from baseline values of diastolic blood pressure
Time frame: Day 28
Actual observed values over time of temperature
Time frame: Baseline and Day 28
Change from baseline values of temperature
Time frame: Day 28
Actual observed values over time of pulse rate
Time frame: Baseline and Day 28
Change from baseline values of pulse rate
Time frame: Day 28
Actual observed values over time of respiration rate
Time frame: Baseline and Day 28
Change from baseline values of respiration rate
Time frame: Day 28
Summary of observed values over time of ECG QT measurements
Time frame: Baseline and Day 28
Change from baseline values over time of ECG QT measurements
Time frame: Day 28
Summary of observed values over time of hemoglobin
Time frame: Baseline and Day 28
Change from baseline values over time of hemoglobin
Time frame: Day 28
Summary of observed values over time of white blood count
Time frame: Baseline and Day 28
Change from baseline values over time of white blood count
Time frame: Day 28
Summary of observed values over time of platelets
Time frame: Baseline and Day 28
Change from baseline values over time of platelets
Time frame: Day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: Yes. All collected de-identified IPD may be shared
Related trials for Acinetobacter Baumannii-calcoaceticus Complex Infection (ABC)
RecruitingPhase 1
A Study to Assess Sulbactam-durlobactam in Pediatric Patients With Acinetobacter Baumannii-calcoaceticus Complex Infection
Acinetobacter Baumannii-calcoaceticus Complex Infection (ABC)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acinetobacter Baumannii-calcoaceticus Complex Infection (ABC), run by Innoviva Specialty Therapeutics at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reddy Tummala ISTX Clinical Trials (617-715-3600, Clinicaltrials@istx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary 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 (time frame: 28 days). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.