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

NCT ID: NCT04223752

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-17
• Study Completion Date: 2024-09-14

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).

Conditions

Nosocomial Pneumonia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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

Group Type: EXPERIMENTAL

Ceftolozane/Tazobactam

Intervention Type: DRUG

Participants 12 to <18 years of age: IV ceftolozane 2 g with tazobactam 1 g infused over a 60-minute period.

Participants <12 years of age: IV ceftolozane 40 mg/kg with tazobactam 20 mg/kg infused over a 60-minute period (not to exceed a dose of ceftolozane 2g and tazobactam 1 g).

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

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

Group Type: EXPERIMENTAL

Ceftolozane/Tazobactam

Intervention Type: DRUG

Participants 12 to <18 years of age: IV ceftolozane 2 g with tazobactam 1 g infused over a 60-minute period.

Participants <12 years of age: IV ceftolozane 40 mg/kg with tazobactam 20 mg/kg infused over a 60-minute period (not to exceed a dose of ceftolozane 2g and tazobactam 1 g).

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

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

Group Type: EXPERIMENTAL

Ceftolozane/Tazobactam

Intervention Type: DRUG

Participants 12 to <18 years of age: IV ceftolozane 2 g with tazobactam 1 g infused over a 60-minute period.

Participants <12 years of age: IV ceftolozane 40 mg/kg with tazobactam 20 mg/kg infused over a 60-minute period (not to exceed a dose of ceftolozane 2g and tazobactam 1 g).

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

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

Group Type: EXPERIMENTAL

Ceftolozane/Tazobactam

Intervention Type: DRUG

Participants 12 to <18 years of age: IV ceftolozane 2 g with tazobactam 1 g infused over a 60-minute period.

Participants <12 years of age: IV ceftolozane 40 mg/kg with tazobactam 20 mg/kg infused over a 60-minute period (not to exceed a dose of ceftolozane 2g and tazobactam 1 g).

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

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

Group Type: EXPERIMENTAL

Ceftolozane/Tazobactam

Intervention Type: DRUG

Participants 12 to <18 years of age: IV ceftolozane 2 g with tazobactam 1 g infused over a 60-minute period.

Participants <12 years of age: IV ceftolozane 40 mg/kg with tazobactam 20 mg/kg infused over a 60-minute period (not to exceed a dose of ceftolozane 2g and tazobactam 1 g).

Interventions

Ceftolozane/Tazobactam

Participants 12 to <18 years of age: IV ceftolozane 2 g with tazobactam 1 g infused over a 60-minute period.

Participants <12 years of age: IV ceftolozane 40 mg/kg with tazobactam 20 mg/kg infused over a 60-minute period (not to exceed a dose of ceftolozane 2g and tazobactam 1 g).

Intervention Type: DRUG

Other Intervention Names

MK-7625A

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.

• Minimum Eligible Age: 7 Days
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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, Kharkivs’ka Oblast’, Ukraine

Institution of Pediatr Obstetr and Gynec NAMS of Ukraine ( Site 1203)

Kyiv, Kyivska Oblast, Ukraine

Countries

United States; Chile; Colombia; Estonia; Greece; Mexico; Russia; Spain; Ukraine

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.merckclinicaltrials.com/

Merck Clinical Trials Information

https://msd.trialsummaries.com/Study/StudyDetails?id=26192&tenant=MT_MSD_9011

Plain Language Summary

Other Identifiers

MK-7625A-036

Identifier Type: OTHER

Identifier Source: secondary_id

2022-501110-56-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1279-4959

Identifier Type: REGISTRY

Identifier Source: secondary_id

2018-004704-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

7625A-036

Identifier Type: -

Identifier Source: org_study_id