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GSK2251052 in Complicated Urinary Tract Infection

NCT01381549 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-09-08

Study results available
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Summary

This study is being conducted to evaluate the safety, efficacy (clinical and microbiological), pharmacokinetics/pharmacodynamics of GSK2251052 and to assess whether it would be a suitable antibiotic for the treatment for febrile lower cUTI and pyelonephritis(complicated and uncomplicated). GSK2251052 will be compared to imipenem-cilastatin, which is an antibiotic commonly used to treat serious cUTI infections. GSK2251052 has a spectrum of microbiological activity that includes pathogens responsible for cUTI.

Conditions

  • Infections, Urinary Tract

Interventions

DRUG

GSK2251052

Reconstituted, added to 250mL 0.9% NaCl solution and administered via IV infusion

DRUG

imipenem-cilastatin

Prepare as per prescribing information instructions in 100 mL bag of 0.9% NaCl and administered via IV infusion

OTHER

Placebo

saline placebo

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-28
Primary Completion
2012-03-06
Completion
2012-03-06

Countries

  • United States
  • Canada
  • France
  • Greece
  • Russia
  • Spain

Study Locations

More Related Trials

Entities

Companies

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 NCT01381549 on ClinicalTrials.gov