Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : August 9, 2019
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 Drug: Meropenem Phase 3

Layout table for study information
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 : July 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cefepime/VNRX-5133
Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period.
Drug: Cefepime/VNRX-5133
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 the 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 including frequency, urgency, dysuria, suprapubic/pelvic pain, and flank pain, patient is alive, and patient has not received additional antibacterial therapy for cUTI.


Secondary Outcome Measures :
  1. Microbiologic and symptomatic success in extended microITT population [ 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. Microbiological success in microbiologically evaluable (ME) population [ Time Frame: Days 19-23 ]
    The proportion of patients with per-patient microbiological success at TOC in the microbiologically evaluable (ME) TOC population.

  3. Symptomatic clinical success in clinical evaluable (CE) and ME population [ Time Frame: Days 19-23 ]
    The proportion of patients with symptomatic clinical success at TOC in the clinically evaluable (CE) TOC and ME-TOC populations.

  4. Investigator opinion of clinical success in microITT and CE and ME populations [ Time Frame: 24 hours after last IV dose: Days 19-23; Days 28-35 ]
    The proportion of patients with clinical success based on investigator opinion at EOT, TOC, and late follow-up (LFU) in the microITT and relevant CE and ME populations.

  5. Per-patient microbiological success in the microITT and ME population [ Time Frame: Days 19-23; Days 28-35 ]
    The proportion of patients with per-patient microbiological success at EOT and LFU in the microITT, ME-EOT, and ME-LFU populations.

  6. Symptomatic clinical success in micro ITT, CE and ME populations [ Time Frame: Days 19-23; Days 28-35 ]
    The proportion of patients with symptomatic clinical success at EOT and LFU in the microITT, CE-EOT, ME-EOT, CE-LFU, and ME-LFU populations.

  7. Per-pathogen microbiological success in microITT and ME populations [ Time Frame: 24 hours after last IV dose: Days 19-23; Days 28-35 ]
    The proportion of patients with per-pathogen microbiological success in the microITT, ME-EOT, ME-TOC, and ME-LFU populations.

  8. Per-patient microbiological success in cefepime resistant pathogens in microITT and ME populations [ Time Frame: 24 hours after IV dose: Days 19-23; Days 28-35 ]
    The proportion of patients with per-patient microbiological success among those with cefepime resistant pathogens in the microITT, ME-EOT, ME-TOC, and ME-LFU populations.

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

  10. Symptomatic clinical success with cefepime resistant pathogens in microITT, CE and ME populations [ Time Frame: 24 hours after last IV dose: Days 19-23; Days 28-35 ]
    The proportion of patients with symptomatic clinical success among those with cefepime-resistant pathogens in the microITT, CE-EOT, CE-TOC, CE-LFU, ME-EOT, ME-TOC, and ME-LFU populations.


Other Outcome Measures:
  1. Safety based on adverse events [ Time Frame: Day 35 ]
    Assessment of adverse and serious adverse events in the clinical study.

  2. Resolution of fever [ Time Frame: Days 28-35 ]
    The time to first defervescence (≤37.8°C) in the microITT population for patients who have fever (>38°C) at baseline will be assessed as an exploratory endpoint.

  3. Plasma pharmacokinetics (PK): Area under the Curve from 0-24 hours [ Time Frame: Day 3 ]
    PK blood samples will be collected on day 3 of study drug administration for the determination of cefepime and VNRX-5133 concentrations in cefepime/VNRX-5133-treated patients.

  4. Plasma PK: Maximum Observed Plasma Drug Concentration (Cmax) [ Time Frame: Day 3 ]
    PK blood samples will be collected on day 3 of study drug administration for the determination of cefepime and VNRX-5133 concentrations in cefepime/VNRX-5133-treated patients.

  5. Plasma PK: Minimum Observed Plasma Drug Concentration (Cmin) [ Time Frame: Day 3 ]
    PK blood samples will be collected on day 3 of study drug administration for the determination of cefepime and VNRX-5133 concentrations in cefepime/VNRX-5133-treated patients.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Layout table for location contacts
Contact: VenatoRx 610-644-8935 venatorxclinical@venatorx.com

Locations
Layout table for location information
United States, California
eStudySite Recruiting
Chula Vista, California, United States, 91911
eStudySite Recruiting
La Mesa, California, United States, 91942
Southbay Pharma Research Recruiting
La Palma, California, United States, 90623
Sponsors and Collaborators
VenatoRx Pharmaceuticals, Inc.

Layout table for additonal information
Responsible Party: VenatoRx Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03840148     History of Changes
Other Study ID Numbers: VNRX-5133-201
2018-001451-13 ( EudraCT Number )
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Communicable Diseases
Urinary Tract Infections
Pyelonephritis
Urologic Diseases
Nephritis, Interstitial
Nephritis
Kidney Diseases
Pyelitis
Meropenem
Cefepime
Anti-Bacterial Agents
Anti-Infective Agents