Safety and Pharmacokinetics of Ceftolozane/Tazobactam in Pediatric Participants With Nosocomial Pneumonia (MK-7625A-036)

Merck Sharp & Dohme LLC41 enrolled

Overview

This is a phase 1, open-label, non-comparative, multicenter clinical study to evaluate the safety, tolerability, and pharmacokinetics of ceftolozane/tazobactam (MK-7625A) in pediatric participants with nosocomial pneumonia (NP).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Nosocomial Pneumonia

Interventions

Ceftolozane/TazobactamDRUG

Participants 12 to \<18 years of age: IV ceftolozane 2 g with tazobactam 1 g infused over a 60-minute period. Participants \<12 years of age: IV ceftolozane 40 mg/kg with tazobactam 20 mg/kg infused over a 60-minute period (not to exceed a dose of ceftolozane 2g and tazobactam 1 g).

Eligibility

Sex: ALLMin age: 7 DaysMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Is hospitalized and anticipated to receive a minimum of 8 days of concomitant standard-of-care \[SOC\] antibiotic therapy for proven or suspected NP. * If male, is abstinent from heterosexual intercourse, or agrees to use contraception during the intervention period and for ≥30 days after the last dose of study intervention. * If female, is not pregnant or breastfeeding, or is not a woman of childbearing potential (WOCBP), or is a WOCBP using acceptable contraception, is a WOCBP with negative urine or serum pregnancy test within 48 hours of the first dose of study intervention, or is abstinent from heterosexual intercourse. Exclusion Criteria: * Has a documented history of any moderate or severe hypersensitivity (or allergic) reaction to any β-lactam antibacterial. * Participants 3 months to \<18 years of age: has moderate to severe impairment of renal function, defined as an estimated creatinine clearance (CrCL) \<50 mL/min/1.73 m2 based on the revised Schwartz equation or requirement for peritoneal dialysis, hemodialysis, or hemofiltration. * Participants \<3 months of age: has CrCL \<20 mL/min/1.73 m2 based on the revised Schwartz equation or requirement for peritoneal dialysis, hemodialysis, or hemofiltration. * Is receiving or is anticipated to receive piperacillin/tazobactam while receiving ceftolozane/tazobactam or has received piperacillin/tazobactam within 24 hours prior to the first dose of ceftolozane/tazobactam. * Has participated in any clinical study of a therapeutic investigational product within 30 days prior to the first dose of ceftolozane/tazobactam. * Has previous participation in any study of ceftolozane or ceftolozane/tazobactam. * Has any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the participant or the quality of study data. * Has any rapidly progressing disease or immediately life-threatening illness including acute hepatic failure or septic shock. * Has active immunosuppression.

Locations (24)

Outcomes

Primary Outcomes

Percentage of Participants With Any Adverse Events (AEs)

An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants experiencing any AE was reported for each arm.

Time frame: Up to 31 days

Percentage of Participants With Any Serious AEs (SAEs)

An SAE was defined as any untoward medical consequence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or any other important medical event. The percentage of participants with any SAE was reported for each arm.

Time frame: Up to 31 days

Percentage of Participants With Any Drug-related AEs

A drug-related AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, and considered related to the study intervention. The percentage of participants with any drug related AEs was reported for each arm.

Time frame: Up to 31 days

Percentage of Participants With Any Drug-related SAEs

A drug-related SAE was defined any untoward medical consequence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or any other important medical event, that is considered related to the study intervention. The percentage of participants with any drug related SAEs was reported for each arm.

Time frame: Up to 31 days

Percentage of Participants With AEs Leading to Discontinuation of Study Intervention

Data from ClinicalTrials.gov

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AdventHealth Orlando ( Site 1318)

Orlando, Florida, United States

Mayo Clinic in Rochester, Minnesota ( Site 1322)

Rochester, Minnesota, United States

Montefiore Medical Center [Bronx, NY] ( Site 1313)

New York, New York, United States

Sanford Children's Hospital ( Site 1301)

Sioux Falls, South Dakota, United States

West Virginia University ( Site 1310)

Morgantown, West Virginia, United States

Children's Wisconsin ( Site 1321)

Milwaukee, Wisconsin, United States

Hospital Roberto del Río ( Site 1400)

Santiago, Region M. de Santiago, Chile

Hospital General de Medellin ( Site 1503)

Medellín, Antioquia, Colombia

Ciensalud Ips S A S ( Site 1501)

Barranquilla, Atlántico, Colombia

Clinica de la Costa S.A.S. ( Site 1500)

Barranquilla, Atlántico, Colombia

...and 14 more locations

Secondary Outcomes

Plasma Concentrations of Ceftolozane

The plasma concentrations of ceftolozane were determined in each group. Blood samples were collected at pre-specified timepoints to determine the plasma concentrations of ceftolozane in participants receiving ceftolozane/tazobactam.