Safety and Pharmacokinetics of Ceftolozane/Tazobactam in Pediatric Participants With Nosocomial P… (NCT04223752) | Clinical Trial Compass
CompletedPhase 1
Safety and Pharmacokinetics of Ceftolozane/Tazobactam in Pediatric Participants With Nosocomial Pneumonia (MK-7625A-036)
United States41 participantsStarted 2020-04-17
Plain-language 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).
Who can participate
Age range7 Days – 17 Years
SexALL
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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 c…
What they're measuring
1
Percentage of Participants With Any Adverse Events (AEs)
Timeframe: Up to 31 days
2
Percentage of Participants With Any Serious AEs (SAEs)
Timeframe: Up to 31 days
3
Percentage of Participants With Any Drug-related AEs
Timeframe: Up to 31 days
4
Percentage of Participants With Any Drug-related SAEs
Timeframe: Up to 31 days
5
Percentage of Participants With AEs Leading to Discontinuation of Study Intervention