drugset / Trial / NCT03477422
CSE-1034 (Ceftriaxone+ Sulbactam+ EDTA) Compared to Meropenem in Complicated Urinary Tract Infections (cUTIs) Caused by ESBL Producing Gram Negative Bacteria
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |