Actively Recruiting
A Study to Assess Sulbactam-durlobactam in Pediatric Patients With Acinetobacter Baumannii-calcoaceticus Complex Infection
Led by Innoviva Specialty Therapeutics · Updated on 2026-03-03
48
Participants Needed
4
Research Sites
81 weeks
Total Duration
On this page
Sponsors
I
Innoviva Specialty Therapeutics
Lead Sponsor
E
Entasis Therapeutics
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A Study to Assess Sulbactam-durlobactam in Pediatric Patients With Acinetobacter Baumannii-calcoaceticus Complex Infection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is hospitalized and between birth (post-natal age of 7 days) and under 18 years old at consent
- Written informed consent and/or assent obtained from patient and/or parent(s) or legal guardian(s)
- Confirmed or suspected Acinetobacter baumannii-calcoaceticus complex infection requiring IV antibiotics
- Expected survival of at least 30 days after enrollment
- Patients of childbearing or reproductive potential must remain abstinent or use effective contraception from 30 days before screening until 30 days after last dose
You will not qualify if you...
- Preterm infants born before 28 weeks gestational age
- History of significant allergy or hypersensitivity to any beta-lactam antibiotics or formulation excipients
- Refractory septic shock at enrollment (persistent low blood pressure despite treatment)
- Pregnancy, breastfeeding, or intention to become pregnant
- Receiving peritoneal dialysis or cardiopulmonary bypass
- Blood transfusion received within 24 hours before study drug administration
- Newborns with clinically significant anemia unable to tolerate blood draws
- Use or need for medications that inhibit organic anion transporter 1 (OAT1), such as probenecid
- Clinically significant unstable renal, hepatic, or hemodynamic conditions
- Weight outside the 5th to 95th percentile for age (for Cohorts 1-3 only)
- Age-appropriate renal impairment by estimated creatinine clearance
- Elevated liver enzymes (AST or ALT >3 times upper limit normal) or bilirubin >2 times upper limit normal with conjugated bilirubin >20% of total, except acute elevations related to infection
- Abnormal lab results not related to infection that pose risk or interfere with study participation
- Participation in any investigational drug or device study within 30 days or 5 half-lives before first dose
- Any condition compromising safety or data quality per investigator judgment
- Inability or unwillingness to comply with protocol
- Prior exposure to durlobactam
- Receipt of sulbactam or sulbactam-containing regimens within 72 hours before first dose
- Receipt of amphotericin B within 7 days before first dose
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
UCLA Medical Center
Los Angeles, California, United States, 90095
Actively Recruiting
2
Rady Children's Hospital
San Diego, California, United States, 92123
Actively Recruiting
3
ECU Brody School of Medicine
Greenville, North Carolina, United States, 27834
Actively Recruiting
4
University of Texas Medical Branch at Galveston
Galveston, Texas, United States, 77555-5302
Actively Recruiting
Research Team
I
ISTX Clinical Trials
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
6
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