Back to resultsSafety and Pharmacokinetics of Ceftolozane/Tazobactam in Pediatric Participants With Nosocomial Pneumonia (MK-7625A-036)
Primary Purpose
Nosocomial Pneumonia
Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Ceftolozane/Tazobactam
Sponsored by
About this trial
This is an interventional treatment trial for Nosocomial Pneumonia
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.
Sites / Locations
- AdventHealth Orlando ( Site 1318)Recruiting
- Montefiore Medical Center [Bronx, NY] ( Site 1313)
- Sanford Children's Hospital ( Site 1301)
- West Virginia University ( Site 1310)Recruiting
- Hospital Roberto del Río ( Site 1400)Recruiting
- Ciensalud Ips S A S ( Site 1501)Recruiting
- Clinica de la Costa S.A.S. ( Site 1500)Recruiting
- SA Tallinna Lastehaigla/Tallinn Children's Hospital ( Site 0201)Recruiting
- SA Tartu Ulikooli Kliinikum Lastekliinik ( Site 0200)Recruiting
- Hippokration General Hospital of Thessaloniki ( Site 0400)Recruiting
- Morozovskaya Children City Clinical Hospital ( Site 0901)Recruiting
- St. Olga Children City Hospital ( Site 0906)Recruiting
- Smolensk Regional Clinical Hospital ( Site 0903)
- Hospital Universitario Sant Joan de Deu ( Site 1100)Recruiting
- SI Dnipropetrovsk Regional Children Clinical Hospital DOR ( Site 1205)Recruiting
- Ivano-Frankivsk Regional Children Clinical Hospital ( Site 1204)Recruiting
- Kharkiv City Children Hospital 16 ( Site 1200)
- Institution of Pediatr Obstetr and Gynec NAMS of Ukraine ( Site 1203)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
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
Arm Description
Participants 12 to <18 years of age with nosocomial pneumonia receive intravenous (IV) ceftolozane/tazobactam every 8 hours for 8-14 days.
Participants 7 to <12 years of age with nosocomial pneumonia receive IV ceftolozane/tazobactam every 8 hours for 8-14 days.
Participants 2 to <7 years of age with nosocomial pneumonia receive IV ceftolozane/tazobactam every 8 hours for 8-14 days.
Participants 3 months to <2 years of age with nosocomial pneumonia receive IV ceftolozane/tazobactam every 8 hours for 8-14 days.
Participants from birth to <3 months of age with nosocomial pneumonia receive IV ceftolozane/tazobactam every 8 hours for 8-14 days.
Outcomes
Primary Outcome Measures
Percentage of participants with any adverse events (AEs)
An AE is 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.
Percentage of participants with any serious AEs (SAEs)
An SAE is 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.
Percentage of participants with any drug-related AEs
A drug-related AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, and considered related to the study intervention.
Percentage of participants with any drug-related SAEs
A drug-related SAE is 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.
Percentage of participants with AEs leading to discontinuation of study intervention
An AE is 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.
Secondary Outcome Measures
Plasma concentrations of ceftolozane
The plasma concentrations of ceftolozane will be determined in each group.
Area under the concentration-time curve of an 8-hour dosing interval (AUC0-8) of plasma ceftolozane
The plasma AUC0-8 of ceftolozane will be determined in each group.
Area under the concentration-time curve of an 8-hour dosing interval (AUC0-8) of plasma tazobactam
The plasma AUC0-8 of tazobactam will be determined in each group.
Maximum observed concentration during a dosage interval (Cmax) of plasma ceftolozane
The plasma Cmax of ceftolozane will be determined in each group.
Maximum observed concentration during a dosage interval (Cmax) of plasma tazobactam
The plasma Cmax of tazobactam will be determined in each group.
Elimination half-life (t1/2) of plasma ceftolozane
The plasma t1/2 of ceftolozane will be determined in each group.
Elimination half-life (t1/2) of plasma tazobactam
The plasma t1/2 of tazobactam will be determined in each group.
Volume of distribution (Vd) of plasma ceftolozane
The plasma Vd of ceftolozane will be determined in each group.
Volume of distribution (Vd) of plasma tazobactam
The plasma Vd of tazobactam will be determined in each group.
Clearance (CL) of plasma ceftolozane
The plasma CL of ceftolozane will be determined in each group.
Clearance (CL) of plasma tazobactam
The plasma CL of tazobactam will be determined in each group.
Full Information
NCT ID
NCT04223752
First Posted
January 8, 2020
Last Updated
October 19, 2023
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT04223752
Brief Title
Safety and Pharmacokinetics of Ceftolozane/Tazobactam in Pediatric Participants With Nosocomial Pneumonia (MK-7625A-036)
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 17, 2020 (Actual)
Primary Completion Date
September 22, 2025 (Anticipated)
Study Completion Date
September 22, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nosocomial Pneumonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1: Ceftolozane/Tazobactam 12 to <18 Years of Age
Arm Type
Experimental
Arm Description
Participants 12 to <18 years of age with nosocomial pneumonia receive intravenous (IV) ceftolozane/tazobactam every 8 hours for 8-14 days.
Arm Title
Group 2: Ceftolozane/Tazobactam 7 to <12 Years of Age
Arm Type
Experimental
Arm Description
Participants 7 to <12 years of age with nosocomial pneumonia receive IV ceftolozane/tazobactam every 8 hours for 8-14 days.
Arm Title
Group 3: Ceftolozane/Tazobactam 2 to <7 Years of Age
Arm Type
Experimental
Arm Description
Participants 2 to <7 years of age with nosocomial pneumonia receive IV ceftolozane/tazobactam every 8 hours for 8-14 days.
Arm Title
Group 4: Ceftolozane/Tazobactam 3 Months to <2 Years of Age
Arm Type
Experimental
Arm Description
Participants 3 months to <2 years of age with nosocomial pneumonia receive IV ceftolozane/tazobactam every 8 hours for 8-14 days.
Arm Title
Group 5: Ceftolozane/Tazobactam Birth to <3 Months of Age
Arm Type
Experimental
Arm Description
Participants from birth to <3 months of age with nosocomial pneumonia receive IV ceftolozane/tazobactam every 8 hours for 8-14 days.
Intervention Type
Drug
Intervention Name(s)
Ceftolozane/Tazobactam
Other Intervention Name(s)
MK-7625A
Intervention Description
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).
Primary Outcome Measure Information:
Title
Percentage of participants with any adverse events (AEs)
Description
An AE is 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.
Time Frame
Up to 31 days
Title
Percentage of participants with any serious AEs (SAEs)
Description
An SAE is 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.
Time Frame
Up to 31 days
Title
Percentage of participants with any drug-related AEs
Description
A drug-related AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, and considered related to the study intervention.
Time Frame
Up to 31 days
Title
Percentage of participants with any drug-related SAEs
Description
A drug-related SAE is 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.
Time Frame
Up to 31 days
Title
Percentage of participants with AEs leading to discontinuation of study intervention
Description
An AE is 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.
Time Frame
Up to 14 days
Secondary Outcome Measure Information:
Title
Plasma concentrations of ceftolozane
Description
The plasma concentrations of ceftolozane will be determined in each group.
Time Frame
Day 3: 1, between 4-5, and between 7-8 hours after start of infusion
Title
Area under the concentration-time curve of an 8-hour dosing interval (AUC0-8) of plasma ceftolozane
Description
The plasma AUC0-8 of ceftolozane will be determined in each group.
Time Frame
Day 3: 1, between 4-5, and between 7-8 hours after start of infusion
Title
Area under the concentration-time curve of an 8-hour dosing interval (AUC0-8) of plasma tazobactam
Description
The plasma AUC0-8 of tazobactam will be determined in each group.
Time Frame
Day 3: 1, between 4-5, and between 7-8 hours after start of infusion
Title
Maximum observed concentration during a dosage interval (Cmax) of plasma ceftolozane
Description
The plasma Cmax of ceftolozane will be determined in each group.
Time Frame
Day 3: 1, between 4-5, and between 7-8 hours after start of infusion
Title
Maximum observed concentration during a dosage interval (Cmax) of plasma tazobactam
Description
The plasma Cmax of tazobactam will be determined in each group.
Time Frame
Day 3: 1, between 4-5, and between 7-8 hours after start of infusion
Title
Elimination half-life (t1/2) of plasma ceftolozane
Description
The plasma t1/2 of ceftolozane will be determined in each group.
Time Frame
Day 3: 1, between 4-5, and between 7-8 hours after start of infusion
Title
Elimination half-life (t1/2) of plasma tazobactam
Description
The plasma t1/2 of tazobactam will be determined in each group.
Time Frame
Day 3: 1, between 4-5, and between 7-8 hours after start of infusion
Title
Volume of distribution (Vd) of plasma ceftolozane
Description
The plasma Vd of ceftolozane will be determined in each group.
Time Frame
Day 3: 1, between 4-5, and between 7-8 hours after start of infusion
Title
Volume of distribution (Vd) of plasma tazobactam
Description
The plasma Vd of tazobactam will be determined in each group.
Time Frame
Day 3: 1, between 4-5, and between 7-8 hours after start of infusion
Title
Clearance (CL) of plasma ceftolozane
Description
The plasma CL of ceftolozane will be determined in each group.
Time Frame
Day 3: 1, between 4-5, and between 7-8 hours after start of infusion
Title
Clearance (CL) of plasma tazobactam
Description
The plasma CL of tazobactam will be determined in each group.
Time Frame
Day 3: 1, between 4-5, and between 7-8 hours after start of infusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Days
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Toll Free Number
Phone
1-888-577-8839
Email
Trialsites@merck.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
AdventHealth Orlando ( Site 1318)
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
407-821-3691
Facility Name
Montefiore Medical Center [Bronx, NY] ( Site 1313)
City
New York
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Completed
Facility Name
Sanford Children's Hospital ( Site 1301)
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Individual Site Status
Completed
Facility Name
West Virginia University ( Site 1310)
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
304-293-1015
Facility Name
Hospital Roberto del Río ( Site 1400)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
8380418
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0992360000
Facility Name
Ciensalud Ips S A S ( Site 1501)
City
Barranquilla
State/Province
Atlantico
ZIP/Postal Code
08001
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
57 3183894721
Facility Name
Clinica de la Costa S.A.S. ( Site 1500)
City
Barranquilla
State/Province
Atlantico
ZIP/Postal Code
080020
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
3116438539
Facility Name
SA Tallinna Lastehaigla/Tallinn Children's Hospital ( Site 0201)
City
Tallinn
State/Province
Harjumaa
ZIP/Postal Code
13419
Country
Estonia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3726977122
Facility Name
SA Tartu Ulikooli Kliinikum Lastekliinik ( Site 0200)
City
Tartu
State/Province
Tartumaa
ZIP/Postal Code
50406
Country
Estonia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3727319550
Facility Name
Hippokration General Hospital of Thessaloniki ( Site 0400)
City
Thessaloniki
State/Province
Kentriki Makedonia
ZIP/Postal Code
546 42
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+306937442644
Facility Name
Morozovskaya Children City Clinical Hospital ( Site 0901)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
119049
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+89255858745
Facility Name
St. Olga Children City Hospital ( Site 0906)
City
Saint-Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
194156
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+78122956957
Facility Name
Smolensk Regional Clinical Hospital ( Site 0903)
City
Smolensk
State/Province
Smolenskaya Oblast
ZIP/Postal Code
214018
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Hospital Universitario Sant Joan de Deu ( Site 1100)
City
Esplugues de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08950
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34932532100
Facility Name
SI Dnipropetrovsk Regional Children Clinical Hospital DOR ( Site 1205)
City
Dnipro
State/Province
Dnipropetrovska Oblast
ZIP/Postal Code
49100
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+380509142649
Facility Name
Ivano-Frankivsk Regional Children Clinical Hospital ( Site 1204)
City
Ivano-Frankivsk
State/Province
Ivano-Frankivska Oblast
ZIP/Postal Code
76014
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+380681040592
Facility Name
Kharkiv City Children Hospital 16 ( Site 1200)
City
Kharkiv
State/Province
Kharkivska Oblast
ZIP/Postal Code
61075
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Institution of Pediatr Obstetr and Gynec NAMS of Ukraine ( Site 1203)
City
Kyiv
State/Province
Kyivska Oblast
ZIP/Postal Code
04050
Country
Ukraine
Individual Site Status
Completed
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Links:
URL
https://www.merckclinicaltrials.com/
Description
Merck Clinical Trials Information
Learn more about this trial
Safety and Pharmacokinetics of Ceftolozane/Tazobactam in Pediatric Participants With Nosocomial Pneumonia (MK-7625A-036)
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