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Safety and Efficacy of ZTI-01 (IV Fosfomycin) vs Piperacillin/Tazobactam for Treatment cUTI/AP Infections

NCT02753946 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 465

Last updated 2019-03-07

Study results available
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Summary

The purpose of the study is to demonstrate the safety and efficacy of ZTI-01 (IV fosfomycin) as non-inferior to piperacillin/tazobactam in overall success (clinical cure and microbiologic eradication) for the treatment of hospitalized patients with complicated urinary tract infections (cUTI) or acute pyelonephritis (AP).

Conditions

  • Urinary Tract Infection Symptomatic
  • Acute Pyelonephritis
  • Urinary Tract Infection Complicated

Interventions

DRUG

ZTI-01

6g ZTI-01 intravenous infusion TID q8 hours

DRUG

Piperacillin-tazobactam

4.5g piperacillin-tazobactam intravenous infusion TID q8 hours

Sponsors & Collaborators

  • Medpace, Inc.

    collaborator INDUSTRY

  • Nabriva Therapeutics AG

    lead INDUSTRY

Principal Investigators

  • Evelyn J Ellis-Grosse, PhD · Zavante Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2017-01-12
Completion
2017-05-30

Countries

  • United States
  • Belarus
  • Bulgaria
  • Croatia
  • Czechia
  • Estonia
  • Georgia
  • Greece
  • Hungary
  • Latvia
  • Lithuania
  • Poland
  • Romania
  • Russia
  • Slovakia
  • Ukraine

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02753946 on ClinicalTrials.gov