NCT01381549

GSK2251052 in Complicated Urinary Tract Infection

A Randomised, Double-blind, Dose-finding, Multicenter Study of the Safety, Tolerability, and Efficacy of GSK2251052 Therapy Compared to Imipenem-cilastatin in the Treatment of Adult Subjects With Febrile Complicated Lower Urinary Tract Infections and Acute Pyelonephritis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2011-06-28
• Primary completion: 2012-03-06
• Completion: 2012-03-06
• First posted: 2011-06-27
• Last updated: 2017-09-08
• Results posted: 2017-09-08

Locations

24 sites across 6 countries: United States, Canada, France, Greece, Russia, Spain