Nosocomial PneumoniaPhase 1NCT04223752
Safety and Pharmacokinetics of Ceftolozane/Tazobactam in Pediatric Participants With Nosocomial Pneumonia (MK-7625A-036)
A Phase 1 study testing Ceftolozane/Tazobactam in people with Nosocomial Pneumonia, run by Merck Sharp & Dohme LLC at 24 sites in 9 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 7 days to 17 years
- Conditions the study is for
- Nosocomial Pneumonia
- What is being tested?
- Ceftolozane/Tazobactam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 24 sitesin 9 countries
- Study dates
- 17 Apr 2020to 14 Sep 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 days to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
24 sites in 9 countries.
24 sites in 9 countries
United States6 sites
Children's Wisconsin ( Site 1321)
Milwaukee, Wisconsin, 53226
West Virginia University ( Site 1310)
Morgantown, West Virginia, 26506
Montefiore Medical Center [Bronx, NY] ( Site 1313)
New York, New York, 10467
AdventHealth Orlando ( Site 1318)
Orlando, Florida, 32803
Mayo Clinic in Rochester, Minnesota ( Site 1322)
Rochester, Minnesota, 55902
Sanford Children's Hospital ( Site 1301)
Sioux Falls, South Dakota, 57105
Colombia4 sites
Ciensalud Ips S A S ( Site 1501)
Barranquilla, Atlántico, 08001
Clinica de la Costa S.A.S. ( Site 1500)
Barranquilla, Atlántico, 080020
Hospital General de Medellin ( Site 1503)
Medellín, Antioquia, 0500515
Oncomédica S.A.S ( Site 1506)
Montería, Departamento de Córdoba, 230002
Ukraine4 sites
SI Dnipropetrovsk Regional Children Clinical Hospital DOR ( Site 1205)
Dnipro, Dnipropetrovsk Oblast, 49100
Ivano-Frankivsk Regional Children Clinical Hospital ( Site 1204)
Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018
Kharkiv City Children Hospital 16 ( Site 1200)
Kharkiv, Kharkiv Oblast, 61075
Institution of Pediatr Obstetr and Gynec NAMS of Ukraine ( Site 1203)
Kyiv, Kyivska Oblast, 04050
Russia3 sites
Morozovskaya Children City Clinical Hospital ( Site 0901)
Moscow, Moscow, 119049
St. Olga Children City Hospital ( Site 0906)
Saint Petersburg, Sankt-Peterburg, 194156
Smolensk Regional Clinical Hospital ( Site 0903)
Smolensk, Smolensk Oblast, 214018
Estonia2 sites
SA Tallinna Lastehaigla/Tallinn Children's Hospital ( Site 0201)
Tallinn, Harju, 13419
SA Tartu Ulikooli Kliinikum Lastekliinik ( Site 0200)
Tartu, Tartu, 50406
Mexico2 sites
Instituto Nacional de Pediatria-Unidad de Apoyo a la Investigación Clínica ( Site 1602)
Mexico City, Mexico City, 04530
Hospital Infantil de Mexico Federico Gomez-Infectious Diseases ( Site 1600)
Mexico City, Mexico City, 06720
Chile1 site
Hospital Roberto del Río ( Site 1400)
Santiago, Region M. de Santiago, 8380418
Greece1 site
Hippokration General Hospital of Thessaloniki ( Site 0400)
Thessaloniki, Central Macedonia, 546 42
Spain1 site
Hospital Universitario Sant Joan de Deu ( Site 1100)
Esplugues de Llobregat, Barcelona, 08950
About this study
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
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
- Being tested
- Ceftolozane/Tazobactam
- Medical subject headings
- Healthcare-Associated Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ceftolozane/TazobactamDrug
Also called MK-7625A
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Ceftolozane/Tazobactam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 14 days
Secondary outcomes (12)
Plasma Concentrations of Ceftolozane
The plasma concentrations of ceftolozane were determined in each group. Blood samples were collected at pre-specified timepoints to determine the plasma concentrations of ceftolozane in participants receiving ceftolozane/tazobactam.
Measured: 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
AUC0-8 was defined as a measure of ceftolozane exposure that was calculated as the product of plasma drug concentration and time. Blood samples were collected at pre-specified timepoints to determine the AUC0-8 of ceftolozane in participants receiving ceftolozane/tazobactam.
Measured: 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
Cmax was defined as the maximum concentration of ceftolozane observed in plasma. Blood samples were collected at pre-specified timepoints to determine the Cmax of ceftolozane in participants receiving ceftolozane/tazobactam.
Measured: Day 3: 1, between 4-5, and between 7-8 hours post start of infusion
Elimination Half-life (t1/2) of Plasma Ceftolozane
Elimination half-life (t1/2) was defined as the time needed to reduce the level of ceftolozane in the blood by one-half (1/2). Blood samples collected at pre-specified timepoints were used to determine the apparent terminal half-life (t1/2) of ceftolozane in participants receiving ceftolozane/tazobactam.
Measured: Day 3: 1, between 4-5, and between 7-8 hours post start of infusion
Clearance (CL) of Plasma Ceftolozane
CL was defined as the total clearance of ceftolozane in plasma over time, assessed as the rate at which ceftolozane was removed from the plasma. Blood samples were collected at pre-specified timepoints to determine the CL of ceftolozane in participants receiving ceftolozane/tazobactam.
Measured: Day 3: 1, between 4-5, and between 7-8 hours post start of infusion
Volume of Distribution (Vd) of Plasma Ceftolozane
Vd was defined as the distributed volume of study drug in plasma at steady state. It is the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of the drug. Blood samples were collected at pre-specified timepoints to determine the Vd of ceftolozane in participants receiving ceftolozane/tazobactam.
Measured: Day 3: 1, between 4-5, and between 7-8 hours post start of infusion
Plasma Concentrations of Tazobactam
The plasma concentrations of tazobactam were determined in each group. Blood samples were collected at pre-specified timepoints to determine the plasma concentrations of tazobactam in participants receiving ceftolozane/tazobactam. No data were calculated for a timepoint if >50% of samples were below limit of quantification (BLOQ).
Measured: 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 Tazobactam
AUC0-8 was defined as a measure of tazobactam exposure that was calculated as the product of plasma drug concentration and time. Blood samples were collected at pre-specified timepoints to determine the AUC0-8 of tazobactam in participants receiving ceftolozane/tazobactam.
Measured: 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 Tazobactam
Cmax was defined as the maximum concentration of tazobactam observed in plasma. Blood samples were collected at pre-specified timepoints to determine the Cmax of tazobactam in participants receiving ceftolozane/tazobactam. The analysis population consisted of participants who received at least 6 doses of ceftolozane/tazobactam and had at least 1 quantifiable plasma concentration of tazobactam.
Measured: Day 3: 1, between 4-5, and between 7-8 hours post start of infusion
Elimination Half-life (t1/2) of Plasma Tazobactam
Elimination half-life (t1/2) was defined as the time needed to reduce the level of tazobactam in the blood by one-half (1/2). Blood samples collected at pre-specified timepoints were used to determine the apparent terminal half-life (t1/2) of tazobactam in participants receiving ceftolozane/tazobactam.
Measured: Day 3: 1, between 4-5, and between 7-8 hours post start of infusion
Clearance (CL) of Plasma Tazobactam
CL was defined as the total clearance of tazobactam in plasma over time, assessed as the rate at which tazobactam was removed from the plasma. Blood samples were collected at pre-specified timepoints to determine the CL of tazobactam in participants receiving ceftolozane/tazobactam.
Measured: Day 3: 1, between 4-5, and between 7-8 hours post start of infusion
Volume of Distribution (Vd) of Plasma Tazobactam
Vd is defined as the distributed volume of study drug in plasma at steady state. It is the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of the drug. Blood samples were collected at pre-specified timepoints to determine the Vd of tazobactam in participants receiving ceftolozane/tazobactam.
Measured: Day 3: 1, between 4-5, and between 7-8 hours post start of infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study start17 Apr 2020
- Primary completion14 Sep 2024
- Study completion14 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Nosocomial PneumoniaStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04223752
- Sponsor's protocol ID
- 7625A-036
- Other IDs
- MK-7625A-036, 2022-501110-56-00, U1111-1279-4959, 2018-004704-19, 2018
- Status last verified
- Aug 2025
- First submitted
- 8 Jan 2020
- Last updated
- 22 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04223752
- Acronym / sponsor ID
- 7625A-036
- Conditions
- Nosocomial Pneumonia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 17 Apr 2020 (actual)
- Primary completion
- 14 Sep 2024 (actual)
- Study completion
- 14 Sep 2024 (actual)
- First posted
- 10 Jan 2020 (actual)
- Results
- Posted 22 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1: Ceftolozane/Tazobactam 12 to <18 Years of Age | Experimental | Drug: Ceftolozane/TazobactamParticipants 12 to <18 years of age with nosocomial pneumonia receive intravenous (IV) ceftolozane/tazobactam every 8 hours for 8-14 days. |
| Group 2: Ceftolozane/Tazobactam 7 to <12 Years of Age | Experimental | Drug: Ceftolozane/TazobactamParticipants 7 to <12 years of age with nosocomial pneumonia receive IV ceftolozane/tazobactam every 8 hours for 8-14 days. |
| Group 3: Ceftolozane/Tazobactam 2 to <7 Years of Age | Experimental | Drug: Ceftolozane/TazobactamParticipants 2 to <7 years of age with nosocomial pneumonia receive IV ceftolozane/tazobactam every 8 hours for 8-14 days. |
| Group 4: Ceftolozane/Tazobactam 3 Months to <2 Years of Age | Experimental | Drug: Ceftolozane/TazobactamParticipants 3 months to <2 years of age with nosocomial pneumonia receive IV ceftolozane/tazobactam every 8 hours for 8-14 days. |
| Group 5: Ceftolozane/Tazobactam Birth to <3 Months of Age | Experimental | Drug: Ceftolozane/TazobactamParticipants from birth to <3 months of age with nosocomial pneumonia receive IV ceftolozane/tazobactam every 8 hours for 8-14 days. |
Who may qualify
- Ages
- 7 days to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ceftolozane/TazobactamAlso: MK-7625AParticipants 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). | Drug | 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 |
Primary outcome
Percentage of Participants With Any Adverse Events (AEs)
Time frame: Up to 31 days
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.
Percentage of Participants With Any Serious AEs (SAEs)
Time frame: Up to 31 days
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.
Percentage of Participants With Any Drug-related AEs
Time frame: Up to 31 days
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.
Percentage of Participants With Any Drug-related SAEs
Time frame: Up to 31 days
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.
Percentage of Participants With AEs Leading to Discontinuation of Study Intervention
Time frame: Up to 14 days
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.
12 secondary outcomes
Plasma Concentrations of Ceftolozane
Time frame: 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
Time frame: 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
Time frame: Day 3: 1, between 4-5, and between 7-8 hours post start of infusion
Elimination Half-life (t1/2) of Plasma Ceftolozane
Time frame: Day 3: 1, between 4-5, and between 7-8 hours post start of infusion
Clearance (CL) of Plasma Ceftolozane
Time frame: Day 3: 1, between 4-5, and between 7-8 hours post start of infusion
Volume of Distribution (Vd) of Plasma Ceftolozane
Time frame: Day 3: 1, between 4-5, and between 7-8 hours post start of infusion
Plasma Concentrations of Tazobactam
Time frame: 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 Tazobactam
Time frame: 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 Tazobactam
Time frame: Day 3: 1, between 4-5, and between 7-8 hours post start of infusion
Elimination Half-life (t1/2) of Plasma Tazobactam
Time frame: Day 3: 1, between 4-5, and between 7-8 hours post start of infusion
Clearance (CL) of Plasma Tazobactam
Time frame: Day 3: 1, between 4-5, and between 7-8 hours post start of infusion
Volume of Distribution (Vd) of Plasma Tazobactam
Time frame: Day 3: 1, between 4-5, and between 7-8 hours post start of infusion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
24 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ceftolozane/Tazobactam in people with Nosocomial Pneumonia, run by Merck Sharp & Dohme LLC at 24 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, Colombia, Ukraine, Russia, Estonia and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Any Adverse Events (AEs) (time frame: Up to 31 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.