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Beta-lactamase inhibitor
Ceftolozane/Tazobactam for Pneumonia
Phase 1
Recruiting
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Is hospitalized and anticipated to receive a minimum of 8 days of concomitant standard-of-care [SOC] antibiotic therapy for proven or suspected NP
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 3: 1, between 4-5, and between 7-8 hours after start of infusion
Awards & highlights
Study Summary
This trial is testing a new antibiotic to treat pneumonia in children. It will assess how well the drug is tolerated and how it affects the body.
Who is the study for?
This trial is for hospitalized children with nosocomial pneumonia who need at least 8 days of antibiotics. Participants must use contraception if applicable and cannot be pregnant or breastfeeding. They shouldn't have severe kidney issues, a history of certain drug reactions, recent participation in other drug studies, active immunosuppression, or life-threatening conditions.Check my eligibility
What is being tested?
The study tests the safety and how the body processes Ceftolozane/Tazobactam (MK-7625A) in pediatric patients with hospital-acquired pneumonia. It's an early-stage trial without comparison to other treatments and involves multiple hospitals.See study design
What are the potential side effects?
While specific side effects are not listed here, similar antibiotics can cause allergic reactions, gastrointestinal symptoms like diarrhea or nausea, headaches, infusion-related reactions such as discomfort at the injection site or fever, and changes in blood test results.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am in the hospital and will be on antibiotics for at least 8 days for pneumonia.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 3: 1, between 4-5, and between 7-8 hours after start of infusion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 3: 1, between 4-5, and between 7-8 hours after start of infusion
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of participants with AEs leading to discontinuation of study intervention
Percentage of participants with any adverse events (AEs)
Percentage of participants with any drug-related AEs
+2 moreSecondary outcome measures
Area under the concentration-time curve of an 8-hour dosing interval (AUC0-8) of plasma ceftolozane
Area under the concentration-time curve of an 8-hour dosing interval (AUC0-8) of plasma tazobactam
Clearance (CL) of plasma ceftolozane
+8 moreSide effects data
From 2016 Phase 4 trial • 21 Patients • NCT0242112010%
Hypokalemia
5%
Liver Function Test Elevation
5%
Vaginal Itching
5%
Type I Hypersensitivity Reaction
5%
Erythema
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ceftolozane/Tazobactam
Trial Design
5Treatment groups
Experimental Treatment
Group I: Group 5: Ceftolozane/Tazobactam Birth to <3 Months of AgeExperimental Treatment1 Intervention
Participants from birth to <3 months of age with nosocomial pneumonia receive IV ceftolozane/tazobactam every 8 hours for 8-14 days.
Group II: Group 4: Ceftolozane/Tazobactam 3 Months to <2 Years of AgeExperimental Treatment1 Intervention
Participants 3 months to <2 years of age with nosocomial pneumonia receive IV ceftolozane/tazobactam every 8 hours for 8-14 days.
Group III: Group 3: Ceftolozane/Tazobactam 2 to <7 Years of AgeExperimental Treatment1 Intervention
Participants 2 to <7 years of age with nosocomial pneumonia receive IV ceftolozane/tazobactam every 8 hours for 8-14 days.
Group IV: Group 2: Ceftolozane/Tazobactam 7 to <12 Years of AgeExperimental Treatment1 Intervention
Participants 7 to <12 years of age with nosocomial pneumonia receive IV ceftolozane/tazobactam every 8 hours for 8-14 days.
Group V: Group 1: Ceftolozane/Tazobactam 12 to <18 Years of AgeExperimental Treatment1 Intervention
Participants 12 to <18 years of age with nosocomial pneumonia receive intravenous (IV) ceftolozane/tazobactam every 8 hours for 8-14 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ceftolozane/Tazobactam
2018
Completed Phase 4
~520
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,582,095 Total Patients Enrolled
6 Trials studying Pneumonia
1,361 Patients Enrolled for Pneumonia
Merck Sharp & Dohme LLCLead Sponsor
3,891 Previous Clinical Trials
5,060,381 Total Patients Enrolled
18 Trials studying Pneumonia
421,721 Patients Enrolled for Pneumonia
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,063,700 Total Patients Enrolled
12 Trials studying Pneumonia
3,413 Patients Enrolled for Pneumonia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently on medication that weakens my immune system.I have been part of a study involving ceftolozane or ceftolozane/tazobactam.I am a male who will not have sex or will use birth control during and for 30 days after the study.I am under 18 with severe kidney problems or on dialysis.I am taking or will take piperacillin/tazobactam with ceftolozane/tazobactam.My baby has severe kidney issues or is on dialysis.I am in the hospital and will be on antibiotics for at least 8 days for pneumonia.I am not pregnant, not breastfeeding, using contraception, or not of childbearing age.You have had a moderate or severe allergic reaction to a type of antibiotic called β-lactam.I do not have any rapidly worsening or immediately life-threatening conditions.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1: Ceftolozane/Tazobactam 12 to <18 Years of Age
- Group 2: Group 2: Ceftolozane/Tazobactam 7 to <12 Years of Age
- Group 3: Group 3: Ceftolozane/Tazobactam 2 to <7 Years of Age
- Group 4: Group 4: Ceftolozane/Tazobactam 3 Months to <2 Years of Age
- Group 5: Group 5: Ceftolozane/Tazobactam Birth to <3 Months of Age
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the recruitment count for this medical experiment?
"Affirmative. Clinicaltrials.gov records demonstrate that this clinical trial is actively enrolling participants, the original posting of which was on April 17th 2020 and last amended on October 20th 2022. 40 potential patients are needed at a solitary site to complete the study."
Answered by AI
What health conditions are usually treated with Ceftolozane/Tazobactam?
"Nosocomial pneumonia is typically treated through the use of Ceftolozane/Tazobactam. This medication can also be advantageous in treating bacterial pneumonias, abdominal infections and urinary tract infections."
Answered by AI
For whom is this clinical trial open to enrollment?
"Patients with nosocomial pneumonia aged between 1 week and 17 years may be selected for this clinical trial, of which 40 participants are being recruited."
Answered by AI
Has Ceftolozane/Tazobactam been granted permission by the FDA?
"Our team at Power gave Ceftolozane/Tazobactam a score of 1 on the safety scale due to it being in a Phase 1 trial, wherein there is limited evidence regarding its efficacy and security."
Answered by AI
Is this research project actively seeking participants?
"Affirmative. Clinicaltrials.gov data demonstrates that this medical experiment, which was first posted on April 17th 2020, is presently searching for volunteers. At least 40 participants need to be enlisted from a single research centre."
Answered by AI
Is the cutoff age for this clinical trial 70 years or below?
"As listed in the patient requirements for this research, applicants must be between 7 days and 17 years old."
Answered by AI
To what end does this research endeavor strive?
"According to Merck Sharp & Dohme LLC, the primary outcome of this trial is Percentage of participants with any drug-related AEs. Additionally, it will also measure secondary endpoints such as Plasma concentrations of ceftolozane, Volume of distribution (Vd) of plasma tazobactam and Clearance (CL) of plasma ceftolozane within a 31 day window."
Answered by AI
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