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Safety and Efficacy Study of Cefepime/VNRX-5133 in Patients With Complicated Urinary Tract Infections

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03840148
Recruitment Status : Recruiting
First Posted : February 15, 2019
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
VenatoRx Pharmaceuticals, Inc.

Brief Summary:
This study will assess the safety and efficacy of cefepime/VNRX-5133 compared with meropenem in both eradication of bacteria and in symptomatic response in patients with cUTIs.

Condition or disease Intervention/treatment Phase
Urinary Tract Infections Acute Pyelonephritis Drug: Cefepime/VNRX-5133 (taniborbactam) Drug: Meropenem Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 582 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-blind, Active Controlled Noninferiority Study Evaluating the Efficacy, Safety, and Tolerability of Cefepime/VNRX-5133 in Adults With Complicated Urinary Tract Infections (cUTI), Including Acute Pyelonephritis
Actual Study Start Date : August 7, 2019
Estimated Primary Completion Date : February 15, 2021
Estimated Study Completion Date : February 27, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cefepime/VNRX-5133 (taniborbactam)
Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period.
Drug: Cefepime/VNRX-5133 (taniborbactam)
Patients will also receive meropenem placebo administered via IV over 30 minutes.

Active Comparator: Meropenem
Meropenem will be administered q8h IV over 30 minutes.
Drug: Meropenem
Patients will also receive cefepime/VNRX-5133 placebo administered via IV over a 2-hour period.




Primary Outcome Measures :
  1. Composite of microbiological eradication and symptomatic clinical success in the microbiological intent-to-treat (microITT) population at test of cure (TOC) [ Time Frame: Days 19-23 ]
    Microbiologic eradication is defined as demonstration that any gram negative bacterial pathogen found at study entry (≥10^5 CFU/mL) is eradicated to <10^3 CFU/mL. Symptomatic clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI.


Secondary Outcome Measures :
  1. Microbiological and symptomatic success at test of cure (TOC) [ Time Frame: Days 19-23 ]
    The proportion of patients with both microbiological success and symptomatic clinical success at TOC in the extended microITT population.

  2. Clinical and microbiological success at end of treatment (EOT) and last follow-up (LFU) [ Time Frame: 24 hours after last IV dose, Days 28-35 ]
    The proportion of patients with both microbiological success and symptomatic clinical success at EOT and LFU.

  3. Per-patient microbiological success at EOT, TOC and LFU [ Time Frame: Within 24 hours of last IV dose, Days 19-23, Days 28-35 ]
    The proportion of patients with per-patient microbiological success at EOT, TOC and LFU.

  4. Patients with symptomatic clinical success at EOT, TOC and LFU [ Time Frame: Within 24 hours of last IV dose, Days 19-23, Days 28-35 ]
    The proportion of patients with symptomatic clinical success at EOT, TOC and LFU.

  5. Investigator opinion of clinical success at TOC [ Time Frame: Days 19-23 ]
    The proportion of patients with clinical success based on investigator opinion at TOC.

  6. Per-pathogen microbiological success at EOT, TOC and LFU [ Time Frame: Within 24 hours of last IV dose, Days 19-23, Days 28-35 ]
    The proportion of patients with per-pathogen microbiological success at EOT, TOC and LFU.

  7. Microbiological and clinical success in cefepime-resistant pathogens at EOT, TOC and LFU [ Time Frame: Within 24 hours of last IV dose, Days 19-23, Days 28-35 ]
    The proportion of patients with both microbiological success and symptomatic clinical success among those with cefepime-resistant pathogens at EOT, TOC and LFU.

  8. Per-patient microbiological success among those with cefepime-resistant pathogens at EOT, TOC and LFU [ Time Frame: Within 24 hours of last IV dose, Days 19-23, Days 28-35 ]
    The proportion of patients with per-patient microbiological success among those with cefepime-resistant pathogens at EOT, TOC and LFU.

  9. Per-pathogen microbiological success among those with cefepime-resistant pathogens at EOT, TOC and LFU [ Time Frame: Within 24 hours of last IV dose, Days 19-23, Days 28-35 ]
    The proportion of patients with per-pathogen microbiological success among those with cefepime-resistant pathogens at EOT, TOC and LFU.

  10. Symptomatic clinical success among those with cefepime-resistant pathogens at EOT, TOC and LFU cefepime-resistant pathogens [ Time Frame: Within 24 hours of last IV dose, Days 19-23, Days 28-35 ]
    The proportion of patients with symptomatic clinical success among those with cefepime-resistant pathogens at EOT, TOC and LFU.


Other Outcome Measures:
  1. Number of participants with adverse events [ Time Frame: Days 35 ]
    Percent of participants experiencing adverse events.

  2. Number of participants with serious adverse events [ Time Frame: Days 35 ]
    Percent of participants experiencing serious adverse events.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult male and female
  • Documented diagnosis of pyuria
  • Documented diagnosis of cUTI or Acute Pyelonephritis (AP)

Exclusion Criteria:

  • Receipt of effective antibacterial drug therapy for cUTI for more than 24 hours during the previous 72 hours prior to randomization
  • A urine culture result is resistant to meropenem or a gram negative pathogen is not identified or more than 2 microorganisms are isolated or a confirmed fungal UTI is identified
  • Required use of nonstudy systemic bacterial therapy
  • Suspected or confirmed prostatitis or urinary tract symptoms attributable to sexually transmitted disease
  • Patients with perinephric or renal abscess
  • Patients with renal transplantation or receiving hemodialysis or peritoneal dialysis
  • Abnormal labs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03840148


Contacts
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Contact: Venatorx 610-644-8935 venatorxclinical@venatorx.com

Locations
Show Show 43 study locations
Sponsors and Collaborators
VenatoRx Pharmaceuticals, Inc.
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Responsible Party: VenatoRx Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03840148    
Other Study ID Numbers: VNRX-5133-201
2018-001451-13 ( EudraCT Number )
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by VenatoRx Pharmaceuticals, Inc.:
Bacterial Infections
Cefepime
Meropenem
Complicated Urinary Tract Infections
Anti-Infective Agents
β-Lactamase Inhibitors
VNRX-5133 (taniborbactam)
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Urinary Tract Infections
Pyelonephritis
Urologic Diseases
Nephritis, Interstitial
Nephritis
Kidney Diseases
Pyelitis
Meropenem
Cefepime
Anti-Bacterial Agents
Anti-Infective Agents