Antibiotic Combinations for Acute Kidney Injury Risk
(MONACO Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two common antibiotic combinations to determine which one is less likely to cause acute kidney injury (AKI), a condition where kidneys suddenly stop functioning properly. The antibiotics involved are vancomycin paired with either piperacillin-tazobactam or cefepime, both used to treat infections in hospitalized patients. The study seeks more accurate indicators of kidney issues than the usual tests, aiming to identify which combination is safer for the kidneys. Individuals with a suspected or confirmed infection, for which either antibiotic combination is considered suitable, might be a good fit for this trial. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, and this research helps understand how it benefits more patients.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, it focuses on patients already prescribed certain antibiotics, so you may need to discuss your current medications with the trial team.
What is the safety track record for these treatments?
Research has shown that different combinations of antibiotics can affect the risk of sudden kidney problems, known as acute kidney injury (AKI). Studies have found no significant increase in kidney issues when vancomycin is used with cefepime compared to other antibiotic combinations. One study even found no difference in kidney health or worsening of AKI with this combination.
However, research consistently indicates that using vancomycin with piperacillin-tazobactam is linked to a higher risk of AKI. This combination is associated with more kidney problems, including more severe stages of AKI, compared to when vancomycin is used with other antibiotics like cefepime.
These findings suggest that while both combinations treat infections, the vancomycin-cefepime combination might be safer for kidney health than the vancomycin-piperacillin-tazobactam combination.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about these antibiotic combinations because they could offer a safer approach to treating infections in patients at risk for acute kidney injury. Traditional treatments often involve using single antibiotics, but combining Vancomycin with Cefepime or Piperacillin-Tazobactam might reduce the potential for kidney damage. These combinations are designed to maintain effectiveness against bacterial infections while minimizing the risk of harming the kidneys, a significant concern with current options. By exploring these combinations, researchers hope to find a treatment strategy that balances powerful infection-fighting capabilities with improved kidney safety.
What evidence suggests that this trial's treatments could be effective for reducing the risk of acute kidney injury?
This trial will compare the effectiveness and risk of kidney problems between two antibiotic combinations: vancomycin with cefepime and vancomycin with piperacillin-tazobactam. Studies have shown that both combinations effectively treat infections. However, research indicates a higher risk of kidney issues with vancomycin and piperacillin-tazobactam compared to vancomycin and cefepime. One study found that 17.5% of patients taking vancomycin with piperacillin-tazobactam developed kidney problems, while only 3.3% of those taking vancomycin with cefepime did. Another study reported similar kidney problem rates for both combinations, but vancomycin with cefepime still showed a slight advantage. Overall, while both treatments work well against infections, vancomycin with cefepime may pose a lower risk for kidney issues.16789
Are You a Good Fit for This Trial?
This trial is for hospitalized patients with suspected or confirmed infections where the doctor thinks both vancomycin combined with either piperacillin-tazobactam or cefepime are good treatment options, and expects to treat them for at least 48 hours.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Vancomycin with Cefepime or Vancomycin with Piperacillin-Tazobactam
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cefepime
- Piperacillin-tazobactam
- Vancomycin
Trial Overview
The study compares the risk of acute kidney injury when treating with two antibiotic combinations: vancomycin plus piperacillin-tazobactam versus vancomycin plus cefepime. It uses sensitive markers to detect kidney damage earlier than standard tests.
How Is the Trial Designed?
2
Treatment groups
Active Control
Participants in the Vancomycin with Cefepime arm will be randomized to initial treatment with Vancomycin with Cefepime. Subsequent management of antimicrobial treatment will be at the discretion of treating clinicians
Participants in the Vancomycin with Piperacillin-Tazobactam arm will be randomized to initial treatment with Vancomycin with Piperacillin-Tazobactam. Subsequent management of antimicrobial treatment will be at the discretion of treating clinicians
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Pennsylvania
Lead Sponsor
Citations
Progression of kidney injury with the combination of ... - PMC
Our study observed no difference in kidney-specific or other secondary outcomes, including the maximum serum creatinine in the first week and AKI progression, ...
Retrospective Cohort Study of the Incidence of Acute Kidney ...
Previous studies demonstrated that the combination of vancomycin and piperacillin-tazobactam increases the risk of AKI compared to vancomycin ...
3.
infectiousdiseaseadvisor.com
infectiousdiseaseadvisor.com/news/higher-aki-with-zosyn-vs-cefepime-in-combination-with-vancomycin/Acute Kidney Injury with Vancomycin, Antipseudomonal ...
There were 120 patients in both VPT and VC groups. In the VPT group, 17.5% of patients (21/120) developed AKI, compared to 3.3% of patients (4/ ...
Renal Comparison of acute kidney injury risk associated ...
Overall, 333 patients were evaluated. The AKI rate in the vancomycin/PTZ group and vancomycin/FEP group were similar (19.5% vs. 17.3%, respectively, p = .
Study Details | NCT06954129 | A Pragmatic Clinical Trial ...
Although these regimens have similar effectiveness, recent observational evidence suggests they may differ in terms of the risk for acute kidney injury (AKI).
Acute kidney injury following the concurrent administration ...
The combination of vancomycin and piperacillin–tazobactam is associated with higher acute kidney injury rates than its parallel use with meropenem or cefepime.
Incidence of Acute Kidney Injury in Critically Ill Patients ...
Recent evidence suggests an increased risk of acute kidney injury (AKI) in patients who received a combination of vancomycin and piperacillin-tazobactam (VPT).
Risk of Acute Kidney Injury in Patients on Concomitant ...
Recent evidence suggests that among patients receiving vancomycin, receipt of concomitant piperacillin–tazobactam increases the risk of nephrotoxicity.
Comparative incidence of acute kidney injury in patients on ...
Abstract. Recent studies have shown that the incidence of nephrotoxicity increases when vancomycin is combined with a beta-lactam antibiotic.
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.