Phase 1
N=41
Safety and Pharmacokinetics of Ceftolozane/Tazobactam in Pediatric Participants With Nosocomial Pneumonia (MK-7625A-036)
Nosocomial Pneumonia
Bottom Line
View on ClinicalTrials.gov: NCT04223752 ↗Enrolled (actual)
41
Serious AEs
20.0%
Results posted
Sep 2025
Primary outcome: Primary: Percentage of Participants With Any Adverse Events (AEs) — 50.0; 71.4; 75.0; 90.0 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Ceftolozane/Tazobactam (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Sep 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Any Adverse Events (AEs) |
50.0; 71.4; 75.0; 90.0; 85.7 | — |
| PRIMARY Percentage of Participants With Any Serious AEs (SAEs) |
12.5; 28.6; 0.0; 30.0; 28.6 | — |
| PRIMARY Percentage of Participants With Any Drug-related AEs |
0.0; 0.0; 0.0; 0.0; 14.3 | — |
| PRIMARY Percentage of Participants With Any Drug-related SAEs |
0.0; 0.0; 0.0; 0.0; 0.0 | — |
| PRIMARY Percentage of Participants With AEs Leading to Discontinuation of Study Intervention |
0.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Plasma Concentrations of Ceftolozane |
93.0; 70.3; 67.6; 54.3; 78.5; 18.8 | — |
| SECONDARY Area Under the Concentration-time Curve of an 8-hour Dosing Interval (AUC0-8) of Plasma Ceftolozane |
260; 230; 202; 282; 360 | — |
| SECONDARY Maximum Observed Concentration During a Dosage Interval (Cmax) of Plasma Ceftolozane |
116; 121; 107; 113; 107 | — |
| SECONDARY Elimination Half-life (t1/2) of Plasma Ceftolozane |
1.87; 1.56; 1.33; 1.79; 2.60 | — |
| SECONDARY Clearance (CL) of Plasma Ceftolozane |
7.68; 4.95; 2.54; 0.919; 0.378 | — |
| SECONDARY Volume of Distribution (Vd) of Plasma Ceftolozane |
16.2; 8.35; 3.97; 2.13; 1.36 | — |
| SECONDARY Plasma Concentrations of Tazobactam |
18.6; 15.5; 15.0; 10.2; 22.2; 0.876 | — |
| SECONDARY Area Under the Concentration-time Curve of an 8-hour Dosing Interval (AUC0-8) of Plasma Tazobactam |
46.7; 50.1; 42.7; 58.3; 72.5 | — |
| SECONDARY Maximum Observed Concentration During a Dosage Interval (Cmax) of Plasma Tazobactam |
36.7; 39.4; 34.2; 38.1; 37.9 | — |
| SECONDARY Elimination Half-life (t1/2) of Plasma Tazobactam |
1.07; 0.932; 0.748; 0.930; 1.23 | — |
| SECONDARY Clearance (CL) of Plasma Tazobactam |
21.4; 11.4; 6.00; 2.22; 0.938 | — |
| SECONDARY Volume of Distribution (Vd) of Plasma Tazobactam |
15.2; 7.71; 3.34; 2.07; 1.38 | — |
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).
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.
Data sourced from ClinicalTrials.gov (NCT04223752). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.