NCT06746883 A Study to Assess the Safety and Risk of Hypersensitivity Reactions of Sulbactam-durlobactam in Adults With Acinetobacter Baumannii-calcoaceticus (ABC) Complex Infection
| NCT ID | NCT06746883 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Innoviva Specialty Therapeutics |
| Condition | Acinetobacter Baumannii-calcoaceticus Complex Infection (ABC) |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-04-28 |
| Primary Completion | 2029-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2025-04-28 with a primary completion date of 2029-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06746883 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acinetobacter Baumannii-calcoaceticus Complex Infection (ABC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06746883 currently recruiting?
Yes, NCT06746883 is actively recruiting participants. Contact the research team at Clinicaltrials@istx.com for enrollment information.
Where is the NCT06746883 trial being conducted?
This trial is being conducted at Sacramento, United States, Gainesville, United States, Tampa, United States, Kansas City, United States and 8 additional locations.
Who is sponsoring the NCT06746883 clinical trial?
NCT06746883 is sponsored by Innoviva Specialty Therapeutics. The trial plans to enroll 100 participants.