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

NCT06801223 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: CS2514-2023-002
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 4

Brief 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)

Keywords

Acinetobacter baumannii-calcoaceticus complex infection; Sulbactam-durlobactam; Hospital-acquired bacteria pneumonia; Ventilator-associated bacterial pneumonia; Acinetobacter; ABC infection

Outcome Measures

Primary Outcomes (2)

• Assess the pharmacokinetic (PK) parameters for maximum concentration (Cmax) of sulbactam and durlobactam

  Day 1 and Day 3

• Assess the PK parameters for area under the plasma concentration-time curve from 0 to 24 hours (AUC 0-24) of sulbactam and durlobactam

  Day 1 and Day 3

Secondary Outcomes (14)

• Percentage of participants experiencing Treatment Emergent Adverse Events (TEAEs)

  28 days

• Percentage of TEAEs leading to study drug discontinuation

  28 days

• Incidence of related TEAEs

  28 days

• Incidence of serious TEAEs

  28 days

• Change from baseline values of liver function measured by Comprehensive Metabolic Panel (CMP)

  Baseline and Day 28

Study Arms (6)

Cohort 1

EXPERIMENTAL

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)

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

Cohort 2

EXPERIMENTAL

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)

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

Cohort 3

EXPERIMENTAL

Pediatric patients 1 year to \<6 years of age

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

Cohort 4

EXPERIMENTAL

Pediatric patients 3 months to \<1 year of age

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

Cohort 5 Subgroup 1

EXPERIMENTAL

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

Drug: Sulbactam 25mg/kg -Durlobactam 25mg/kg (Every 6 hours); Drug: Sulbactam 20mg/kg-Durlobactam 20mg/kg (Every 8 hours)

Cohort 5 Subgroup 2

EXPERIMENTAL

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

Drug: Sulbactam 25mg/kg -Durlobactam 25mg/kg (Every 8 hours); Drug: Sulbactam 20mg/kg-Durlobactam 20mg/kg (Every 12 hours)

Interventions

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

25mg/kg SUL and 25mg/kg DUR

Also known as: SUL-DUR

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5 Subgroup 1

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

20mg/kg SUL and 20mg/kg DUR

Also known as: SUL-DUR

Cohort 5 Subgroup 1

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

25mg/kg SUL and 25mg/kg DUR

Also known as: SUL-DUR

Cohort 5 Subgroup 2

Sulbactam 20mg/kg-Durlobactam 20mg/kg (Every 12 hours) DRUG

20mg/kg SUL and 20mg/kg DUR

Also known as: SUL-DUR

Cohort 5 Subgroup 2

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patient from birth (defined as post-natal age of 7 days) to \<18 years of age at the time of written informed consent (and assent, if applicable) and is hospitalized.
• Patient and/or parent(s) or legal guardian(s) have provided the written informed consent and/or assent.
• Patient has confirmed or suspected diagnosis of ABC infection and requires IV antibiotics for treatment.
• Patient has expected survival of 30 days after enrollment in the study.
• If patient is an individual of childbearing potential or reproductive potential, then the patient must remain abstinent OR must utilize one of the highly effective methods of contraception (ie, condom, combined oral contraceptive, implant, or injectable) from at least 30 days prior to screening until at least 30 days after administration of the last dose of study drug.

You may not qualify if:

• Patient is a preterm infant, born at \<28 weeks gestational age.
• Patient has history of significant hypersensitivity or allergic reaction to any β-lactam, any contraindication to the excipients used in the formulation, or any contraindication to the use of β-lactam antibiotics. Note: For β-lactams, a history of a mild rash followed by uneventful re-exposure is not a contraindication to enrollment.
• Patient is in refractory septic shock at the time of enrollment, defined as persistent hypotension despite adequate fluid resuscitation or vasopressive therapy.
• Patient is pregnant, breastfeeding, or intends to become pregnant.
• Patient is receiving peritoneal dialysis or cardiopulmonary bypass.
• Patient has received blood transfusion within 24 hours of study drug administration.
• Patient is a newborn with clinically significant anemia who, in the opinion of the investigator, will not be able to tolerate the necessary blood draws to complete the study activities.
• Patient (or patient's mother, if the patient is being breastfed) is using or will need to use any medications known to inhibit organic anion transporter 1 (OAT1) (eg, probenecid).
• Patient has clinically significant renal, hepatic, or hemodynamic instability.
• For Cohorts 1 through 3 only: patient has weight outside of the 5th to 95th percentile based on age.
• Patient has an age-appropriate estimated creatinine clearance that indicates renal impairment.
• Patient has the following laboratory results at Screening:
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>3×upper limit of normal (ULN) and,
• Total bilirubin \>2×ULN for age with conjugated/direct bilirubin \>20% of the total. Note: Patients with AST or ALT up to 5×ULN are eligible if these elevations are acute and are documented as being directly related to the infectious process being treated.
• Patient has clinically significant abnormal laboratory test results not related to the underlying infection that might expose the patient to risk by participating in the trial, confound the results of the trial, or interfere with the patient's participation for the full duration of the trial.

Sponsors & Collaborators

• Innoviva Specialty Therapeutics: lead
• Entasis Therapeutics: collaborator

Study Sites (4)

UCLA Medical Center

Los Angeles, California, 90095, United States

RECRUITING

Rady Children's Hospital

San Diego, California, 92123, United States

RECRUITING

ECU Brody School of Medicine

Greenville, North Carolina, 27834, United States

RECRUITING

University of Texas Medical Branch at Galveston

Galveston, Texas, 77555-5302, United States

RECRUITING

MeSH Terms

Interventions

Sulbactam; durlobactam

Intervention Hierarchy (Ancestors)

Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

ISTX Clinical Trials

CONTACT

617-715-3600; Clinicaltrials@istx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: January 30, 2025
• Study Start (Estimated): October 30, 2026
• Primary Completion (Estimated): May 5, 2028
• Study Completion (Estimated): May 20, 2028
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data requests may be submitted starting 6 months after primary article publication and the data will be made accessible for up to 24 months; extensions may be considered on a case-by-case basis. Access criteria: Subject to certain criteria, conditions, and exceptions and upon completion of the review
• Access Criteria: Subject to certain criteria, conditions, and exceptions and upon completion of the review and approval of the Research Proposal and Statistical Analysis Plan, Qualified Researchers engaging in independent scientific research can be provided de-identified IPD following the execution of a Data Sharing Agreement

Locations

US (4)