A Study to Assess Sulbactam-durlobactam in Pediatric Patients With Acinetobacter Baumannii-calcoa… (NCT06801223) | Clinical Trial Compass
RecruitingPhase 1
A Study to Assess Sulbactam-durlobactam in Pediatric Patients With Acinetobacter Baumannii-calcoaceticus Complex Infection
United States48 participantsStarted 2026-10-30
Plain-language 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
Who can participate
Age range1 Day – 18 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Assess the pharmacokinetic (PK) parameters for maximum concentration (Cmax) of sulbactam and durlobactam
Timeframe: Day 1 and Day 3
2
Assess the PK parameters for area under the plasma concentration-time curve from 0 to 24 hours (AUC 0-24) of sulbactam and durlobactam
✕. 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).