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| Name | Class |
|---|---|
| Entasis Therapeutics | INDUSTRY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
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| 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) |
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| Cohort 3 | Experimental | Pediatric patients 1 year to <6 years of age |
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| Cohort 4 | Experimental | Pediatric patients 3 months to <1 year of age |
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| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sulbactam 25mg/kg -Durlobactam 25mg/kg (Every 6 hours) | Drug | 25mg/kg SUL and 25mg/kg DUR |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants experiencing Treatment Emergent Adverse Events (TEAEs) | Defined as any adverse event occurring after exposure to the study drug or any AE that worsens in intensity or frequency | 28 days |
| Percentage of TEAEs leading to study drug discontinuation |
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Inclusion Criteria:
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.
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:
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.
Patient (or patient's mother, if the patient is being breastfed) has participated in a clinical study involving investigational medication or an investigational device within the last 30 days or 5 half-lives, whichever is longer, prior to first dose of the study drug.
Patient has any condition that, in the opinion of the investigator, would compromise the safety of the patient or the quality of the data.
Patient is unable or unwilling, in the opinion of the investigator, to comply with the protocol.
Patient (or patient's mother, if the patient is being breastfed) has previously received durlobactam.
Patient (or patient's mother, if the patient is being breastfed) has received sulbactam and/or sulbactam-containing regimens (eg, Unasyn) within 72 hours of first dose of the study drug.
Patient (or patient's mother, if the patient is being breastfed) has received amphotericin B within 7 days of first dose of the study drug.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ISTX Clinical Trials | Contact | 617-715-3600 | Clinicaltrials@istx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Medical Center | Recruiting | Los Angeles | California | 90095 | United States | |
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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
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
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| 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 |
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| Sulbactam 20mg/kg-Durlobactam 20mg/kg (Every 8 hours) | Drug | 20mg/kg SUL and 20mg/kg DUR |
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| Sulbactam 25mg/kg -Durlobactam 25mg/kg (Every 8 hours) | Drug | 25mg/kg SUL and 25mg/kg DUR |
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| Sulbactam 20mg/kg-Durlobactam 20mg/kg (Every 12 hours) | Drug | 20mg/kg SUL and 20mg/kg DUR |
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| 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 |
| Change from baseline values of kidney function measured by CMP | Baseline and Day 28 |
| Change from baseline values of hemoglobin | Baseline and Day 28 |
| Change from baseline value of white blood cell count | Baseline and Day 28 |
| Change from baseline value of platelets | Baseline and Day 28 |
| Change from baseline value of diastolic blood pressure | Baseline and Day 28 |
| Change from baseline value of systolic blood pressure | Baseline and Day 28 |
| Change from baseline values of heart rate | Baseline and Day 28 |
| Change from baseline value of respiration rate | Baseline through Day 28 |
| Change from baseline value of temperature | Baseline and Day 28 |
| Rady Children's Hospital |
| Recruiting |
| San Diego |
| California |
| 92123 |
| United States |
| ECU Brody School of Medicine | Recruiting | Greenville | North Carolina | 27834 | United States |
| University of Texas Medical Branch at Galveston | Recruiting | Galveston | Texas | 77555-5302 | United States |
| ID | Term |
|---|---|
| D013407 | Sulbactam |
| C000626193 | durlobactam |
| ID | Term |
|---|---|
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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