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Evaluation of Safety and Efficacy of Intravenous Sulbactam-ETX2514 in the Treatment of Hospitalized Adults With Complicated Urinary Tract Infections

NCT03445195 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2020-01-22

Study results available
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Summary

This study is a double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of IV ETX2514SUL in patients with complicated urinary tract infections (cUTIs) who are otherwise relatively healthy.

Conditions

  • Complicated Urinary Tract Infection
  • Acute Pyelonephritis

Interventions

DRUG

Sulbactam-ETX2514

The ETX2514SUL regimen of 1 g ETX2514/1 g sulbactam infused over 3 hours q6h.

DRUG

Placebo

Matching 1g IV solution.

DRUG

Imipenem-cilastatin

All patients will receive background therapy with 500 mg IV imipenem/cilastatin q6h.

Sponsors & Collaborators

  • Entasis Therapeutics

    lead INDUSTRY

Principal Investigators

  • Anibal Calmaggi, MD · Medpace, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-17
Primary Completion
2018-05-17
Completion
2018-05-17
FDA Drug
Yes

Countries

  • Bulgaria

Study Locations

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Entities

Drugs

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 NCT03445195 on ClinicalTrials.gov