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Study Comparing the Safety and Efficacy of Intravenous CXA-201 and Intravenous Levofloxacin in Complicated Urinary Tract Infection, Including Pyelonephritis

NCT01345929 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 558

Last updated 2018-10-25

Study results available
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Summary

This is a Phase 3, multicenter, prospective, randomized, double-blind, double dummy study of CXA 201 IV infusions (1500 mg q8h) versus levofloxacin IV infusions (750 mg qd) for the treatment of adults with a cUTI (including pyelonephritis).

Conditions

  • Complicated Urinary Tract Infection
  • Pyelonephritis

Interventions

DRUG

CXA-201

CXA-201 IV infusion (1500mg q8) for 7 days

DRUG

Levofloxacin

Levofloxacin IV infusion (750mg qd) for 7 days

Sponsors & Collaborators

  • Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

    lead INDUSTRY

Principal Investigators

  • Obiamiwe Umeh, M.D., MSc. · Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-20
Primary Completion
2013-08-11
Completion
2013-09-04

Countries

  • United States
  • Brazil
  • Colombia
  • Estonia
  • Georgia
  • Germany
  • Hungary
  • Israel
  • Latvia
  • Mexico
  • Moldova
  • Romania
  • Russia
  • Serbia
  • Slovakia
  • South Africa
  • Thailand

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 NCT01345929 on ClinicalTrials.gov