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A Study to Assess the Safety and Risk of Hypersensitivity Reactions of Sulbactam-durlobactam in Adults With Acinetobacter Baumannii-calcoaceticus (ABC) Complex Infection

StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Minor Study sites: 10 to 12v13
  2. Minor Study sites: 8 to 10v12
  3. Minor Site details revised at 1 of 8 sitesv11
  4. Minor Study sites: 6 to 8v10
  5. Minor Study sites: 4 to 6v9
Show 7 earlier versionsHide 7 earlier versions
  1. Minor Study sites: 3 to 4v8
  2. Minor Study sites: 2 to 3v7
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 30, 2025 to Apr 28, 2025
    • Site details revised at 2 of 2 sites
    v6
  4. Minor Study sites: 1 to 2v5
  5. Notable Start date: Mar 31, 2025 to Apr 30, 2025v4
  6. Notable Start date: Feb 28, 2025 to Mar 31, 2025
    • Interventions: Sulbactam-Durlobactam (Drug) to Non-interventional (Other)
    • Study title expanded, about 2 words
    v3
  7. Notable Start date: Dec 13, 2024 to Feb 28, 2025v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06746883
Lead Sponsor Innoviva Specialty Therapeutics
Conditions
(from sponsor)
Acinetobacter Baumannii-calcoaceticus Complex Infection (ABC)
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov