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

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

Age range

0–18 years

Sex

All

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)