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

Completed · Phase 1

Conditions studied: Nosocomial Pneumonia

In brief

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).

Key facts

Study ID

NCT04223752

Run by

Merck Sharp & Dohme LLC

People needed

41

Starts

2020-04-17

Expected to finish

2024-09-14

Last updated by the study team

2025-09-22

Who can join

Age: 0 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• Oncomédica S.A.S ( Site 1506) — Montería, Departamento de Córdoba, Colombia
• SA Tallinna Lastehaigla/Tallinn Children's Hospital ( Site 0201) — Tallinn, Harju, Estonia
• SA Tartu Ulikooli Kliinikum Lastekliinik ( Site 0200) — Tartu, Tartu, Estonia
• Hippokration General Hospital of Thessaloniki ( Site 0400) — Thessaloniki, Central Macedonia, Greece
• Instituto Nacional de Pediatria-Unidad de Apoyo a la Investigación Clínica ( Site 1602) — Mexico City, Mexico City, Mexico
• Hospital Infantil de Mexico Federico Gomez-Infectious Diseases ( Site 1600) — Mexico City, Mexico City, Mexico
• Morozovskaya Children City Clinical Hospital ( Site 0901) — Moscow, Moscow, Russia
• St. Olga Children City Hospital ( Site 0906) — Saint Petersburg, Sankt-Peterburg, Russia
• Smolensk Regional Clinical Hospital ( Site 0903) — Smolensk, Smolensk Oblast, Russia
• Hospital Universitario Sant Joan de Deu ( Site 1100) — Esplugues de Llobregat, Barcelona, Spain
• SI Dnipropetrovsk Regional Children Clinical Hospital DOR ( Site 1205) — Dnipro, Dnipropetrovsk Oblast, Ukraine
• Ivano-Frankivsk Regional Children Clinical Hospital ( Site 1204) — Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine
• Kharkiv City Children Hospital 16 ( Site 1200) — Kharkiv, Kharkiv Oblast, Ukraine
• Institution of Pediatr Obstetr and Gynec NAMS of Ukraine ( Site 1203) — Kyiv, Kyivska Oblast, Ukraine

Full record on ClinicalTrials.gov

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