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

NCT04223752 | Completed Phase 1 Results FDA Drug

• 5 other identifiers: 7625A-036MK-7625A-0362022-501110-56-00U1111-1279-49592018-004704-19
• Study Type: interventional
• Target: 41
• Locations: 8 countries
• Sites: 23

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

Outcome Measures

Primary Outcomes (5)

• Percentage of Participants With Any Adverse Events (AEs)

  An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants experiencing any AE was reported for each arm.

  Up to 31 days

• Percentage of Participants With Any Serious AEs (SAEs)

  An SAE was defined as any untoward medical consequence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or any other important medical event. The percentage of participants with any SAE was reported for each arm.

  Up to 31 days

• Percentage of Participants With Any Drug-related AEs

  A drug-related AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, and considered related to the study intervention. The percentage of participants with any drug related AEs was reported for each arm.

  Up to 31 days

• Percentage of Participants With Any Drug-related SAEs

  A drug-related SAE was defined any untoward medical consequence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or any other important medical event, that is considered related to the study intervention. The percentage of participants with any drug related SAEs was reported for each arm.

  Up to 31 days

• Percentage of Participants With AEs Leading to Discontinuation of Study Intervention

  An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with AEs leading to discontinuation of study intervention was reported for each arm.

  Up to 14 days

Secondary Outcomes (12)

• Plasma Concentrations of Ceftolozane

  Day 3: 1, between 4-5, and between 7-8 hours post start of infusion

• Area Under the Concentration-time Curve of an 8-hour Dosing Interval (AUC0-8) of Plasma Ceftolozane

  Day 3: 1, between 4-5, and between 7-8 hours post start of infusion

• Maximum Observed Concentration During a Dosage Interval (Cmax) of Plasma Ceftolozane

  Day 3: 1, between 4-5, and between 7-8 hours post start of infusion

• Elimination Half-life (t1/2) of Plasma Ceftolozane

  Day 3: 1, between 4-5, and between 7-8 hours post start of infusion

• Clearance (CL) of Plasma Ceftolozane

  Day 3: 1, between 4-5, and between 7-8 hours post start of infusion

Study Arms (5)

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

EXPERIMENTAL

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

Drug: Ceftolozane/Tazobactam

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

EXPERIMENTAL

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

Drug: Ceftolozane/Tazobactam

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

EXPERIMENTAL

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

Drug: Ceftolozane/Tazobactam

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

EXPERIMENTAL

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

Drug: Ceftolozane/Tazobactam

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

EXPERIMENTAL

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

Drug: Ceftolozane/Tazobactam

Interventions

Ceftolozane/Tazobactam 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).

Also known as: MK-7625A

Group 1: Ceftolozane/Tazobactam 12 to <18 Years of Age; Group 2: Ceftolozane/Tazobactam 7 to <12 Years of Age; Group 3: Ceftolozane/Tazobactam 2 to <7 Years of Age; Group 4: Ceftolozane/Tazobactam 3 Months to <2 Years of Age; Group 5: Ceftolozane/Tazobactam Birth to <3 Months of Age

Eligibility Criteria

• Age: 7 Days - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (24)

AdventHealth Orlando ( Site 1318)

Orlando, Florida, 32803, United States

Location

Mayo Clinic in Rochester, Minnesota ( Site 1322)

Rochester, Minnesota, 55902, United States

Location

Montefiore Medical Center [Bronx, NY] ( Site 1313)

New York, New York, 10467, United States

Location

Sanford Children's Hospital ( Site 1301)

Sioux Falls, South Dakota, 57105, United States

Location

West Virginia University ( Site 1310)

Morgantown, West Virginia, 26506, United States

Location

Children's Wisconsin ( Site 1321)

Milwaukee, Wisconsin, 53226, United States

Location

Hospital Roberto del Río ( Site 1400)

Santiago, Region M. de Santiago, 8380418, Chile

Location

Hospital General de Medellin ( Site 1503)

Medellín, Antioquia, 0500515, Colombia

Location

Ciensalud Ips S A S ( Site 1501)

Barranquilla, Atlántico, 08001, Colombia

Location

Clinica de la Costa S.A.S. ( Site 1500)

Barranquilla, Atlántico, 080020, Colombia

Location

Oncomédica S.A.S ( Site 1506)

Montería, Departamento de Córdoba, 230002, Colombia

Location

SA Tallinna Lastehaigla/Tallinn Children's Hospital ( Site 0201)

Tallinn, Harju, 13419, Estonia

Location

SA Tartu Ulikooli Kliinikum Lastekliinik ( Site 0200)

Tartu, Tartu, 50406, Estonia

Location

Hippokration General Hospital of Thessaloniki ( Site 0400)

Thessaloniki, Central Macedonia, 546 42, Greece

Location

Instituto Nacional de Pediatria-Unidad de Apoyo a la Investigación Clínica ( Site 1602)

Mexico City, Mexico City, 04530, Mexico

Location

Hospital Infantil de Mexico Federico Gomez-Infectious Diseases ( Site 1600)

Mexico City, Mexico City, 06720, Mexico

Location

Morozovskaya Children City Clinical Hospital ( Site 0901)

Moscow, Moscow, 119049, Russia

Location

St. Olga Children City Hospital ( Site 0906)

Saint Petersburg, Sankt-Peterburg, 194156, Russia

Location

Smolensk Regional Clinical Hospital ( Site 0903)

Smolensk, Smolensk Oblast, 214018, Russia

Location

Hospital Universitario Sant Joan de Deu ( Site 1100)

Esplugues de Llobregat, Barcelona, 08950, Spain

Location

SI Dnipropetrovsk Regional Children Clinical Hospital DOR ( Site 1205)

Dnipro, Dnipropetrovsk Oblast, 49100, Ukraine

Location

Ivano-Frankivsk Regional Children Clinical Hospital ( Site 1204)

Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018, Ukraine

Location

Kharkiv City Children Hospital 16 ( Site 1200)

Kharkiv, Kharkivs’ka Oblast’, 61075, Ukraine

Location

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

Kyiv, Kyivska Oblast, 04050, Ukraine

Location

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Healthcare-Associated Pneumonia

Interventions

ceftolozane, tazobactam drug combination

Condition Hierarchy (Ancestors)

Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@msd.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2020
• First Posted: January 10, 2020
• Study Start: April 17, 2020
• Primary Completion: September 14, 2024
• Study Completion: September 14, 2024
• Last Updated: September 22, 2025
• Results First Posted: September 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

US (6); ME (2); CO (4); GR (1); UA (4); CL (1); RU (3); ES (2)