Brief Summary
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).
Brief Title
Safety and Pharmacokinetics of Ceftolozane/Tazobactam in Pediatric Participants With Nosocomial Pneumonia (MK-7625A-036)
Categories
Completion Date
Completion Date Type
Actual
Conditions
Nosocomial Pneumonia
Eligibility Criteria
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.
* 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.
Inclusion Criteria
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.
* 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.
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
17 Years
Minimum Age
7 Days
NCT Id
NCT04223752
Org Class
Industry
Org Full Name
Merck Sharp & Dohme LLC
Org Study Id
7625A-036
Overall Status
Completed
Phases
Phase 1
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
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
Primary Outcomes
Outcome Description
An AE is 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.
Outcome Measure
Percentage of participants with any adverse events (AEs)
Outcome Time Frame
Up to 31 days
Outcome Description
An SAE is 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.
Outcome Measure
Percentage of participants with any serious AEs (SAEs)
Outcome Time Frame
Up to 31 days
Outcome Description
A drug-related AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, and considered related to the study intervention.
Outcome Measure
Percentage of participants with any drug-related AEs
Outcome Time Frame
Up to 31 days
Outcome Description
A drug-related SAE is 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.
Outcome Measure
Percentage of participants with any drug-related SAEs
Outcome Time Frame
Up to 31 days
Outcome Description
An AE is 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.
Outcome Measure
Percentage of participants with AEs leading to discontinuation of study intervention
Outcome Time Frame
Up to 14 days
Secondary Ids
Secondary Id
MK-7625A-036
Secondary Id
2022-501110-56-00
Secondary Id
2018-004704-19
Secondary Outcomes
Outcome Description
The plasma concentrations of ceftolozane will be determined in each group.
Outcome Time Frame
Day 3: 1, between 4-5, and between 7-8 hours after start of infusion
Outcome Measure
Plasma concentrations of ceftolozane
Outcome Description
The plasma AUC0-8 of ceftolozane will be determined in each group.
Outcome Time Frame
Day 3: 1, between 4-5, and between 7-8 hours after start of infusion
Outcome Measure
Area under the concentration-time curve of an 8-hour dosing interval (AUC0-8) of plasma ceftolozane
Outcome Description
The plasma AUC0-8 of tazobactam will be determined in each group.
Outcome Time Frame
Day 3: 1, between 4-5, and between 7-8 hours after start of infusion
Outcome Measure
Area under the concentration-time curve of an 8-hour dosing interval (AUC0-8) of plasma tazobactam
Outcome Description
The plasma Cmax of ceftolozane will be determined in each group.
Outcome Time Frame
Day 3: 1, between 4-5, and between 7-8 hours after start of infusion
Outcome Measure
Maximum observed concentration during a dosage interval (Cmax) of plasma ceftolozane
Outcome Description
The plasma Cmax of tazobactam will be determined in each group.
Outcome Time Frame
Day 3: 1, between 4-5, and between 7-8 hours after start of infusion
Outcome Measure
Maximum observed concentration during a dosage interval (Cmax) of plasma tazobactam
Outcome Description
The plasma t1/2 of ceftolozane will be determined in each group.
Outcome Time Frame
Day 3: 1, between 4-5, and between 7-8 hours after start of infusion
Outcome Measure
Elimination half-life (t1/2) of plasma ceftolozane
Outcome Description
The plasma t1/2 of tazobactam will be determined in each group.
Outcome Time Frame
Day 3: 1, between 4-5, and between 7-8 hours after start of infusion
Outcome Measure
Elimination half-life (t1/2) of plasma tazobactam
Outcome Description
The plasma Vd of ceftolozane will be determined in each group.
Outcome Time Frame
Day 3: 1, between 4-5, and between 7-8 hours after start of infusion
Outcome Measure
Volume of distribution (Vd) of plasma ceftolozane
Outcome Description
The plasma Vd of tazobactam will be determined in each group.
Outcome Time Frame
Day 3: 1, between 4-5, and between 7-8 hours after start of infusion
Outcome Measure
Volume of distribution (Vd) of plasma tazobactam
Outcome Description
The plasma CL of ceftolozane will be determined in each group.
Outcome Time Frame
Day 3: 1, between 4-5, and between 7-8 hours after start of infusion
Outcome Measure
Clearance (CL) of plasma ceftolozane
Outcome Description
The plasma CL of tazobactam will be determined in each group.
Outcome Time Frame
Day 3: 1, between 4-5, and between 7-8 hours after start of infusion
Outcome Measure
Clearance (CL) of plasma tazobactam
See Also Links
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Child
Maximum Age Number (converted to Years and rounded down)
17
Minimum Age Number (converted to Years and rounded down)
0
Investigators
Investigator Type
Principal Investigator
Investigator Name
Michelle Collins-Ogle
Investigator Email
mogle@montefiore.org
Investigator Phone
919-451-0413