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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Innoviva Specialty Therapeutics
Study ID
NCT06801223
Phase
PHASE1
Status
Recruiting
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Conditions

  • Acinetobacter Baumannii-calcoaceticus Complex Infection (ABC)

Eligibility Criteria

Sex
ALL
Age
1 Day - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Sulbactam 25mg/kg -Durlobactam 25mg/kg (Every 6 hours) — DRUG
    25mg/kg SUL and 25mg/kg DUR
  • Sulbactam 20mg/kg-Durlobactam 20mg/kg (Every 8 hours) — DRUG
    20mg/kg SUL and 20mg/kg DUR
  • Sulbactam 25mg/kg -Durlobactam 25mg/kg (Every 8 hours) — DRUG
    25mg/kg SUL and 25mg/kg DUR
  • Sulbactam 20mg/kg-Durlobactam 20mg/kg (Every 12 hours) — DRUG
    20mg/kg SUL and 20mg/kg DUR

Study Details

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

Key Dates

Start date
Oct 30, 2026
Status verified
Feb 2026
Primary completion
May 5, 2028
Completion
May 20, 2028

Study Design

Enrollment
48 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    Pediatric patients 12 years to \<18 years of age Sulbactam 25mg/kg -Durlobactam 25mg/kg, not to exceed 1g sulbactam - 1g durlobactam (Every 6 hours)
  • Experimental: Cohort 2
    Pediatric patients 6 years to \<12 years of age Sulbactam 25mg/kg -Durlobactam 25mg/kg, not to exceed 1g sulbactam - 1g durlobactam (Every 6 hours)
  • Experimental: Cohort 3
    Pediatric patients 1 year to \<6 years of age
  • Experimental: Cohort 4
    Pediatric patients 3 months to \<1 year of age
  • Experimental: Cohort 5 Subgroup 1
    Aged 2 months to \<3 months, term and preterm (gestational age \>28 weeks) Term infants will receive 25mg/kg SUL and 25mg/kg DUR Preterm infants will receive 20mg/kg SUL and 20mg/kg DUR
  • Experimental: Cohort 5 Subgroup 2
    Aged birth to \<2 months, term and preterm (gestational age \>28 weeks and post-natal age \>7 days) Term infants will receive 25mg/kg SUL and 25mg/kg DUR Preterm infants will receive 20mg/kg SUL and 20mg/kg DUR

Primary Outcome Measure

Assess the pharmacokinetic (PK) parameters for maximum concentration (Cmax) of sulbactam and durlobactam [ Time Frame: Day 1 and Day 3 ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
UCLA Medical CenterLos AngelesCalifornia90095-
Rady Children's HospitalSan DiegoCalifornia92123-
ECU Brody School of MedicineGreenvilleNorth Carolina27834-
University of Texas Medical Branch at GalvestonGalvestonTexas77555-5302-

Find similar trials in Los Angeles, CA

By research site
UCLA Medical Center· Los Angeles, CARady Children's Hospital· San Diego, CAECU Brody School of Medicine· Greenville, NCUniversity of Texas Medical Branch at Galveston· Galveston, TX

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