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Compares treatment options for Acute Kidney Injury
Official title A Pragmatic Clinical Trial Comparing the Risk of Acute Kidney Injury During Treatment With Vancomycin and Piperacillin-Tazobactam vs. Vancomycin and Cefepime in Hospitalized Patients
ClinicalTrials.gov ID: NCT06954129
What this study is testing
What is Vancomycin?
Vancomycin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute kidney injury.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Hospitalized patients with suspected or confirmed infection are commonly treated with vancomycin (VN) in combination with either piperacillin-tazobactam (PT) or cefepime (CP). Although these regimens have similar effectiveness, recent observational evidence suggests they may differ in terms of the risk for acute kidney injury (AKI).
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age of at least 18 years
- Suspected or confirmed infection based on clinical criteria, for which vancomycin with piperacillin-tazobactam or vancomycin with cefepime was...
- The treating clinician considers both vancomycin with piperacillin- tazobactam or vancomycin with cefepime as acceptable treatment
- The treating clinician anticipates at least 48 hours of antibiotic treatment
You likely can't join if
- Dialysis dependence or documented end stage kidney disease
- AKI at baseline
- Expected survival \<24 hours and/or presence of do not resuscitate orders
- History of antibiotic-resistant organisms (microbiological culture results showing bacterial isolates with resistant or intermediate susceptibility...
- Documented allergy to vancomycin, cephalosporins, or penicillin
- Suspected central nervous system infection
See the full eligibility criteria
- Age of at least 18 years
- Suspected or confirmed infection based on clinical criteria, for which vancomycin with piperacillin-tazobactam or vancomycin with cefepime was prescribed by the treating clinician, as evidenced by orders being placed in...
- The treating clinician considers both vancomycin with piperacillin- tazobactam or vancomycin with cefepime as acceptable treatment
- The treating clinician anticipates at least 48 hours of antibiotic treatment
- Dialysis dependence or documented end stage kidney disease
- AKI at baseline
- Expected survival \<24 hours and/or presence of do not resuscitate orders
- History of antibiotic-resistant organisms (microbiological culture results showing bacterial isolates with resistant or intermediate susceptibility to any study drug within the prior 90 days)
- Documented allergy to vancomycin, cephalosporins, or penicillin
- Suspected central nervous system infection
- Inability to provide informed consent or lack of proxy for consent
- Prisoners/incarcerated individuals
- Known pregnancy or breastfeeding
- Previous enrollment in this study
- Receipt of vancomycin, piperacillin-tazobactam, or cefepime for \>24 hours within the preceding 7 days. At the time of screening, one-time doses of vancomycin, with or without piperacillin-tazobactam, or cefepime, will...
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.