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RECRUITING
NCT06801223
PHASE1

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

Sponsor: Innoviva Specialty Therapeutics

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

All

Age Range

1 Day - 18 Years

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2026-10-30

Completion Date

2028-05-20

Last Updated

2026-03-03

Healthy Volunteers

No

Interventions

DRUG

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

25mg/kg SUL and 25mg/kg DUR

DRUG

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

20mg/kg SUL and 20mg/kg DUR

DRUG

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

25mg/kg SUL and 25mg/kg DUR

DRUG

Sulbactam 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