RecruitingPhase 1NCT06801223

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

A Multicenter, Open-label, Phase 1b Study to Assess the Pharmacokinetics, Safety, and Tolerability of Sulbactam-Durlobactam in Hospitalized Pediatric Patients From Birth to <18 Years Who Are Receiving Systemic Antibiotic Therapy for Suspected or Confirmed Acinetobacter Baumannii-calcoaceticus Complex Infection

Sponsor

Innoviva Specialty Therapeutics

Enrollment

48 participants

Start Date

Oct 30, 2026

Study Type

INTERVENTIONAL

Conditions

Acinetobacter Baumannii-calcoaceticus Complex Infection (ABC)

Summary

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

Eligibility

Min Age: 1 DayMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Sulbactam 20mg/kg-Durlobactam 20mg/kg (Every 12 hours), a drug called Sulbactam 20mg/kg-Durlobactam 20mg/kg (Every 8 hours), and others for people with acinetobacter baumannii-calcoaceticus complex infection (abc). The study is currently recruiting participants at 4 locations. People eligible for this study include aged 1 Day to 18 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSulbactam 25mg/kg -Durlobactam 25mg/kg (Every 6 hours)

25mg/kg SUL and 25mg/kg DUR

DRUGSulbactam 20mg/kg-Durlobactam 20mg/kg (Every 8 hours)

20mg/kg SUL and 20mg/kg DUR

DRUGSulbactam 25mg/kg -Durlobactam 25mg/kg (Every 8 hours)

25mg/kg SUL and 25mg/kg DUR

DRUGSulbactam 20mg/kg-Durlobactam 20mg/kg (Every 12 hours)

20mg/kg SUL and 20mg/kg DUR

Locations(4)

UCLA Medical Center

Los Angeles, California, United States

Rady Children's Hospital

San Diego, California, United States

ECU Brody School of Medicine

Greenville, North Carolina, United States

University of Texas Medical Branch at Galveston

Galveston, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06801223

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