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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Nosocomial Pneumonia

Treatments: Drug: Ceftolozane/Tazobactam

Study type: Interventional

Funder types: Industry

Identifiers

NCT04223752

MK-7625A-036 (Other Identifier)

2022-501110-56-00 (Registry Identifier)

7625A-036

2018-004704-19 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 40 patients

Sex: All

Ages: 7 days to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 5 patient groups

Group 1: Ceftolozane/Tazobactam 12 to <18 Years of Age

Experimental group

Description:

Participants 12 to \<18 years of age with nosocomial pneumonia receive intravenous (IV) ceftolozane/tazobactam every 8 hours for 8-14 days.

Treatment:

Drug: Ceftolozane/Tazobactam

Group 2: Ceftolozane/Tazobactam 7 to <12 Years of Age

Experimental group

Description:

Participants 7 to \<12 years of age with nosocomial pneumonia receive IV ceftolozane/tazobactam every 8 hours for 8-14 days.

Treatment:

Drug: Ceftolozane/Tazobactam

Group 3: Ceftolozane/Tazobactam 2 to <7 Years of Age

Experimental group

Description:

Participants 2 to \<7 years of age with nosocomial pneumonia receive IV ceftolozane/tazobactam every 8 hours for 8-14 days.

Treatment:

Drug: Ceftolozane/Tazobactam

Group 4: Ceftolozane/Tazobactam 3 Months to <2 Years of Age

Experimental group

Description:

Participants 3 months to \<2 years of age with nosocomial pneumonia receive IV ceftolozane/tazobactam every 8 hours for 8-14 days.

Treatment:

Drug: Ceftolozane/Tazobactam

Group 5: Ceftolozane/Tazobactam Birth to <3 Months of Age

Experimental group

Description:

Participants from birth to \<3 months of age with nosocomial pneumonia receive IV ceftolozane/tazobactam every 8 hours for 8-14 days.

Treatment:

Drug: Ceftolozane/Tazobactam