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Beta-lactamase inhibitor / Cephalosporin
Ceftolozane-Tazobactam for Pseudomonas Infections
Phase 1 & 2
Recruiting
Led By Thomas Walsh, MD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At least 18 years old
Presence of hematologic malignancy or Hematopoietic Stem Cell Transplantation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10, day 11, day 12, day 13, day 14, day 15, day 16, day 17, day 18, day 19, day 20, day 21, day 22, day 23, day 24, day 25, day 26, day 27, day 28, day 30, day 60
Awards & highlights
Study Summary
This trial will test if ceftolozane-tazobactam can effectively treat Pseudomonas aeruginosa infections.
Who is the study for?
This trial is for adults over 18 with blood cancers or who've had a stem cell transplant and are now facing Pseudomonas aeruginosa infections. It's not suitable for those under 18, expected to die within 48 hours, on kidney dialysis treatments, or allergic to cephalosporin antibiotics.Check my eligibility
What is being tested?
The study tests Ceftolozane-Tazobactam injections as the main treatment for certain serious bacterial infections in patients with hematological conditions. Everyone knows what treatment they're getting (open-label), and they'll be watched over for about two months.See study design
What are the potential side effects?
Ceftolozane-Tazobactam might cause side effects like allergic reactions, possible kidney issues in some people, gastrointestinal symptoms such as nausea or diarrhea, headaches, and potential changes in liver enzymes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have a blood cancer or have had a stem cell transplant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10, day 11, day 12, day 13, day 14, day 15, day 16, day 17, day 18, day 19, day 20, day 21, day 22, day 23, day 24, day 25, day 26, day 27, day 28, day 30, day 60
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10, day 11, day 12, day 13, day 14, day 15, day 16, day 17, day 18, day 19, day 20, day 21, day 22, day 23, day 24, day 25, day 26, day 27, day 28, day 30, day 60
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Global response at end of therapy
Secondary outcome measures
Change in days until emergence of other bacteria
Change of microbiological eradication
Incidence of abnormal and physical examinations findings - abdomen
+18 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Ceftolozane-TazobactamExperimental Treatment1 Intervention
Participants receive ceftolozane-tazobactam by injection directly into the vein (intravenously, IV) every 8 hours for 10-14 days.
Find a Location
Who is running the clinical trial?
Weill Medical College of Cornell UniversityLead Sponsor
1,055 Previous Clinical Trials
1,316,275 Total Patients Enrolled
3 Trials studying Pneumonia
496 Patients Enrolled for Pneumonia
Merck Sharp & Dohme LLCIndustry Sponsor
3,892 Previous Clinical Trials
5,060,651 Total Patients Enrolled
18 Trials studying Pneumonia
421,741 Patients Enrolled for Pneumonia
Thomas Walsh, MDPrincipal InvestigatorWeill Medical College of Cornell University
1 Previous Clinical Trials
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on hemodialysis or continuous renal replacement therapy.You are expected to pass away within the next 48 hours.I am 18 years old or older.I am under 18 years old.I have a blood cancer or have had a stem cell transplant.You have had a severe allergic reaction to cephalosporin antibiotics.
Research Study Groups:
This trial has the following groups:- Group 1: Ceftolozane-Tazobactam
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there still room to join this experiment for participants?
"The clinical trial is still in its recruitment phase. The initial posting date was July 20th 2022, with the most recent edit occurring on July 29th of that same year."
Answered by AI
What is the common purpose of administering Ceftolozane / Tazobactam Injection?
"Ceftolozane / Tazobactam Injection is a useful medication for nosocomial pneumonia and other illnesses such as bacterial pneumonias, abdominal infections, and urinary tract infection."
Answered by AI
What is the limit to how many individuals are taking part in this experiment?
"Affirmative. Clinicaltrials.gov discloses that this clinical trial is presently recruiting; it was first posted on July 20th 2022, and most recently amended on the 29th of July 2022. The study intends to enroll 20 patients across a single medical centre."
Answered by AI
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