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

NCT06801223 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-03-03

No results posted yet for this study

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

Conditions

  • Acinetobacter Baumannii-calcoaceticus Complex Infection (ABC)

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

Sponsors & Collaborators

  • Entasis Therapeutics

    collaborator INDUSTRY

  • Innoviva Specialty Therapeutics

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Day
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-30
Primary Completion
2028-05-05
Completion
2028-05-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06801223 on ClinicalTrials.gov