Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT03630081
Recruitment Status : Not yet recruiting
First Posted : August 14, 2018
Last Update Posted : March 7, 2019
Sponsor:
Collaborator:
Medpace Finland OY
Information provided by (Responsible Party):
Wockhardt

Brief Summary:
This is a Phase III, randomized, double-blind, multicenter, non-inferiority study to evaluate the efficacy, safety, and tolerability of FEP-TAZ vs. meropenem in the treatment of hospitalized adults with cUTI or AP.

Condition or disease Intervention/treatment Phase
Complicated Urinary Tract Infection Acute Pyelonephritis Drug: FEP-TAZ 4 g Drug: Meropenem Drug: ciprofloxacin 500 mg Optional Oral Switch Other: Placebo infusion Phase 3

Detailed Description:

Approximately 1004 hospitalized adult subjects (≥18 years of age) diagnosed with cUTI or AP will be enrolled in the study. The diagnosis of cUTI or AP will be based on a combination of clinical symptoms and signs plus the presence of pyuria

Subjects will be randomized in a 1:1 ratio according to an Interactive Response Technology (IRT) electronic system to receive either FEP-TAZ 4 g (2 g cefepime + 2 g tazobactam) IV every eight hours (q8h) or meropenem 1 g IV q8h. FEP-TAZ will be administered as 2 consecutive infusions of 2 g (1 g cefepime + 1 g tazobactam)


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1004 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Double-Blind, Multicenter, Comparative Study to Determine the Efficacy and Safety of Cefepime-Tazobactam vs. Meropenem Followed by Optional Oral Therapy in the Treatment of Complicated Urinary Tract Infection or Acute Pyelonephritis in Adults
Estimated Study Start Date : August 25, 2019
Estimated Primary Completion Date : December 25, 2020
Estimated Study Completion Date : December 25, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: FEP-TAZ 4 g
FEP-TAZ Pharmaceutical dosage form: Intravenous infusion Dosage: 4 g (2 g FEP and 2 g TAZ) IV q8h, infused over 90 min
Drug: FEP-TAZ 4 g
4 g (2 g FEP and 2 g TAZ) IV q8h, infused over 90 min

Drug: ciprofloxacin 500 mg Optional Oral Switch
ciprofloxacin 500 mg PO q12h

Active Comparator: Meropenem
Meropenem Pharmaceutical dosage form: Intravenous infusion Dosage: 1 g IV q8h, infused over 45 min
Drug: Meropenem
1 g IV q8h, infused over 45 min

Drug: ciprofloxacin 500 mg Optional Oral Switch
ciprofloxacin 500 mg PO q12h

Other: Placebo infusion
Placebo infusion (normal saline) over 45 min




Primary Outcome Measures :
  1. overall success by clinical response by improvement in clinical symptoms e.g.fever [ Time Frame: Day 5 ]
  2. overall success by microbiological eradication by laboratory culture tests e.g bacterial load [ Time Frame: Day 5 ]
  3. overall safety will be based on incidence of number of TEAEs [ Time Frame: 28 days ]
  4. overall safety will be based on incidence of number of abnormal electrocardiograms (ECGs) evaluations [ Time Frame: 28 days ]


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:

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

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): NCT03630081


Contacts
Layout table for location contacts
Contact: Manishkumar D Shah, PhD 91-22-26596893 Manish.Shah@wockhardt.com
Contact: Mugdha A Gupta, MMS 91-22-26596892 mgupta@wockhardt.com

Sponsors and Collaborators
Wockhardt
Medpace Finland OY
Investigators
Layout table for investigator information
Study Director: Ashima Bhatia, MD Wockhardt

Layout table for additonal information
Responsible Party: Wockhardt
ClinicalTrials.gov Identifier: NCT03630081     History of Changes
Other Study ID Numbers: W-4282-301
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Communicable Diseases
Urinary Tract Infections
Pyelonephritis
Urologic Diseases
Nephritis, Interstitial
Nephritis
Kidney Diseases
Pyelitis
Ciprofloxacin
Meropenem
Tazobactam
Cefepime
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
beta-Lactamase Inhibitors