Study of Cefepime-tazobactam (FEP-TAZ) in Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)

Launched by WOCKHARDT · Aug 13, 2018

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called Cefepime-tazobactam (FEP-TAZ) for adults who are hospitalized with complicated urinary tract infections (cUTI) or acute pyelonephritis (AP). The goal is to see how effective and safe this new treatment is compared to another antibiotic called meropenem. The trial will involve a randomized process, meaning participants will randomly receive either FEP-TAZ or meropenem without knowing which one they are getting. This helps researchers understand which treatment works better for these infections.

To be eligible for the trial, participants need to be between 65 and 74 years old and must show specific symptoms related to cUTI or AP, such as fever, nausea, or pain when urinating. They also need to have complicating factors that make their infection more serious. However, individuals with certain serious health conditions or those who have recently received other antibiotics may not qualify. If someone decides to participate, they can expect close monitoring throughout the study to ensure their safety and to track how well the treatment is working. This trial is currently not recruiting participants, but it offers an opportunity to help advance treatment options for these challenging infections.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Meet the following clinical criteria for either cUTI or AP:
• A. cUTI:
• 1. Have at least TWO of the following new-onset or worsening symptoms or signs:
• • Fever (oral, tympanic, or rectal temperature \>38°C \[\>100.4°F\]), which must be observed and documented by a health care provider Nausea or vomiting Dysuria, increased urinary frequency, or urinary urgency Lower abdominal, suprapubic, or pelvic pain
• • 2. Have at least ONE complicating factor
• B. AP, defined as acute flank pain (onset within 7 days prior to randomization) or costovertebral angle tenderness on physical examination, plus at least ONE of the following new-onset or worsening symptoms or signs:
• • 3. Evidence of pyuria within 48 h prior to randomization,
• Exclusion Criteria:
• • 1. Known or suspected disease or condition that, in the opinion of the investigator, may confound the assessment of efficacy.
• • 2. Receipt of potentially-effective systemic antibacterial therapy within 72 h prior to randomization
• • 3. Rapidly progressive or terminal illness with a high risk of mortality due to any cause, including but not limited to acute hepatic failure, respiratory failure, or septic shock, such that the subject is unlikely to survive the study period