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A Study to Assess Sulbactam-durlobactam in Pediatric Patients With Acinetobacter Baumannii-calcoaceticus Complex Infection

StatusRecruiting
PhasePhase 1
Started
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Record History

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  1. Start date: Oct 30, 2026 to Dec 30, 2026
    • Interventions: Sulbactam 20mg/kg-Durlobactam 20mg/kg (Every 12 hours) (Drug), Sulbactam 20mg/kg-Durlobactam 20mg/kg (Every 8 hours) (Drug), Sulbactam… to Sulbactam 20mg/kg-Durlobactam 20mg/kg (Every 12 hours) (Drug), Sulbactam 20mg/kg-Durlobactam 20mg/kg (Every 8 hours) (Drug), Sulbactam…
    • Eligibility criteria expanded, about 26 words
    • Site details revised at 1 of 4 sites
  2. Start date: Feb 28, 2026 to Oct 30, 2026
    • Eligibility criteria shortened, about 7 words
    v9
  3. Start date: Oct 30, 2025 to Feb 28, 2026v8
  4. Start date: Aug 30, 2025 to Oct 30, 2025
    • Study sites: 1 to 4
    v7
  5. Start date: Jul 30, 2025 to Aug 30, 2025v6
Show 4 earlier versionsHide 4 earlier versions
  1. Start date: May 30, 2025 to Jul 30, 2025v5
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Mar 31, 2025 to May 30, 2025
    • Site details revised
    v4
  3. Start date: Jan 31, 2025 to Mar 31, 2025v3
  4. Interventions: Sulbactam 20mg/kg-Durlobactam 20mg/kg (Drug), Sulbactam 25mg/kg -Durlobactam 25mg/kg (Drug) to Sulbactam 20mg/kg-Durlobactam 20mg/kg (Every 12 hours) (Drug), Sulbactam 20mg/kg-Durlobactam 20mg/kg (Every 8 hours) (Drug), Sulbactam…v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 clinical trial is to investigate the use of Sulbactam-Durlobactam (SUL-DUR) in pediatric patients and is being conducted to collect pharmacokinetic (PK) and safety data to enable the identification of appropriate pediatric dosing regimens for patients with Acinetobacter baumannii-calcoaceticus complex (ABC) infections
Trial Details
NCT Number NCT06801223
Lead Sponsor Innoviva Specialty Therapeutics
Collaborators: Entasis Therapeutics
Conditions
(from sponsor)		 Acinetobacter Baumannii-calcoaceticus Complex Infection (ABC)
Enrollment 48 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov