drugset / Trial / NCT01381549

GSK2251052 in Complicated Urinary Tract Infection

NCT01381549 ↗

Phase 2 Terminated 20 enrolled GlaxoSmithKline
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

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

Outcome

Outcome not reported

Stopped: “Microbiological findings of resistance on therapy in patients with complicated urinary tract infection”

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cilastatin Small molecule 500 mg Intravenous
Subject Epetraborole Small molecule 750 mg Intravenous
Subject Epetraborole Small molecule 1500 mg Intravenous
Comparator IMIPENEM ANHYDROUS Small molecule 500 mg Intravenous