852 Participants NeededMy employer runs this trial

Piperacillin/Tazobactam vs Meropenem for Infections

(VPS Trial)

Recruiting at 2 trial locations
AH
JV
JV
AS
Overseen ByAletha Sprague
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Bassett Healthcare
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two common antibiotics, Piperacillin/Tazobactam and Meropenem, to assess their impact on kidney health in patients with serious infections. By determining which antibiotic combination is safer, doctors can make more informed treatment decisions. Hospitalized patients with serious infections who require these antibiotics may qualify for participation. As a Phase 4 trial, this research examines an already FDA-approved treatment to understand its benefits for a broader patient population, providing an opportunity to contribute to safer antibiotic use.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for these treatments?

Research has shown that both piperacillin/tazobactam and meropenem are generally well-tolerated treatments. Piperacillin/tazobactam is considered safe; one study showed that 93% of patients experienced improvement in their infection symptoms. Safety results were similar across different antibiotic treatments. This medication is often used for various infections in both adults and children.

Meropenem is also considered safe. In a study involving infants, 50% experienced some side effects, but only 17% were serious. Another study found that meropenem successfully treated infections in up to 93.4% of cases. The FDA has approved these antibiotics, indicating they have been tested and found safe and effective for other conditions.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments because Piperacillin/Tazobactam and Meropenem offer distinct approaches to fighting infections often treated with antibiotics like amoxicillin or ceftriaxone. Piperacillin/Tazobactam combines a broad-spectrum penicillin with a beta-lactamase inhibitor, which helps it tackle bacteria that have become resistant to other antibiotics. On the other hand, Meropenem is a carbapenem antibiotic known for its potency against a wide range of bacteria, including those that are hard to treat. Both treatments are being evaluated for their effectiveness in combination with vancomycin, potentially offering more robust solutions for severe infections.

What is the effectiveness track record for Piperacillin/Tazobactam and Meropenem in treating serious infections?

This trial will compare the effectiveness of two antibiotics, Piperacillin/Tazobactam and Meropenem, for treating infections. Studies have shown that Meropenem, one of the antibiotics tested in this trial, effectively treats serious infections. It works well against bacteria and is often used in hospitals. Research indicates that administering Meropenem slowly over a longer period can lead to better recovery and shorter ICU stays. In contrast, studies on Piperacillin/Tazobactam, the other antibiotic under study, show mixed results. Some studies suggest it works for certain infections, but others have linked it to higher death rates in patients with sepsis. Both antibiotics have FDA approval, but current evidence suggests Meropenem might be more effective and safer in critical cases.678910

Who Is on the Research Team?

DF

Daniel Freilich, MD

Principal Investigator

Bassett Medical Center

Are You a Good Fit for This Trial?

This trial is for adults (18+) in the hospital with a serious or suspected infection who need strong antibiotics. They must have working kidneys, no severe kidney disease, and not be allergic to beta-lactam antibiotics. Consent must be given before starting or just after the first antibiotic dose.

Inclusion Criteria

I have a serious infection needing strong combination antibiotics like VPT or VM.
Consenting/enrollment will not clinically significantly delay antibiotic administration
Patient or legally authorized representative able to provide informed consent
See 4 more

Exclusion Criteria

I have moderate to severe chronic kidney disease.
Beta lactam allergy
I cannot safely receive VPT or VM treatments.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either vancomycin plus piperacillin/tazobactam or vancomycin plus meropenem to assess renal effects

7 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including kidney injury biomarkers and infectious complications

90 days

What Are the Treatments Tested in This Trial?

Interventions

  • Meropenem
  • Piperacillin/Tazobactam

Trial Overview

The study compares two FDA-approved antibiotic combinations—meropenem versus piperacillin/tazobactam—to see which is safer for the kidneys in hospitalized patients with serious infections. Patients are randomly assigned to one of these treatments.

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: Piperacillin/tazobactamActive Control1 Intervention
Group II: MeropenemActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Bassett Healthcare

Lead Sponsor

Trials
23
Recruited
1,400+

Johns Hopkins University

Collaborator

Trials
2,366
Recruited
15,160,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials
592
Recruited
27,110,000+

Citations

Initial Meropenem Plasma Concentration and Its Correlation ...

Meropenem, a carbapenem antibiotic, is known for its potent antibacterial activity and broad-spectrum efficacy, frequently employed in anti- ...

Comparison of the Effectiveness of Prolonged Infusion and ...

Our results demonstrated that prolonged meropenem infusion not only improved clinical outcomes but also led to reduced ICU stays and overall ...

Impact of prolonged versus intermittent infusion ...

Conclusions. Prolonged infusion of meropenem is more effective than intermittent infusion in reducing mortality, improving clinical outcomes, and enhancing ...

Changes of PK/PD of Meropenem in patients with ...

This study aimed to explore the changes of pharmacokinetic parameters after meropenem in patients with abdominal septic shock after ...

Update on the Efficacy and Tolerability of Meropenem in the ...

Compared with clindamycin/tobramycin, meropenem is associated with a reduced length of hospital stay and a shorter duration of therapy among patients with ...

Real-world Multicenter Analysis of Clinical Outcomes ... - PMC

MEV was used in 40 patients with complicated MDR infections and was successful in 70.0% (28/40). Clinical failure was largely attributed to failure to resolve ...

Effectiveness, Tolerance, and Safety of Meropenem in ... - PMC

Despite uncertainties regarding the stability of meropenem in OPAT, the overall success rate of 93.4% in the current study is consistent with previously ...

Safety and Effectiveness of Meropenem in Infants With ...

Results. Of 200 subjects enrolled in the study, 99 (50%) experienced an adverse event, and 34 (17%) had serious adverse events; no adverse ...

Continuous, Intermittent Administration of Meropenem for ...

Continuous administration of meropenem did not improve clinical outcomes compared with intermittent administration of the antibiotic in critically ill patients ...

Clinical efficacy and safety of meropenem in the treatment ...

Conclusion: Meropenem can effectively improve the condition of neonates with bacterial infectious pneumonia, and it has fewer adverse reactions, ...