drugset / Trial / NCT03477422

CSE-1034 (Ceftriaxone+ Sulbactam+ EDTA) Compared to Meropenem in Complicated Urinary Tract Infections (cUTIs) Caused by ESBL Producing Gram Negative Bacteria

NCT03477422

Phase 3 Completed 230 enrolled Venus Remedies Limited
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate the effects of CSE-1034 (Ceftriaxone+ Sulbactam+ EDTA) compared to Meropenem for treating hospitalized patients with complicated urinary tract infections, including acute pyelonephritis caused by β-lactamase producing gram-negative bacteria

Timeline

Start
2014-01-11
Primary completion
2017-05-08
Completion
2017-05-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Ceftriaxone Other / unclassified 1000 mg Intravenous
Subject Edetate Calcium Disodium Unknown 37 mg Intravenous
Comparator Meropenem Small molecule 1000 mg Intravenous
Subject Sulbactam Small molecule 500 mg Intravenous

Indications