CSE-1034 (Ceftriaxone+ Sulbactam+ EDTA) Compared to Meropenem in Complicated Urinary Tract Infections (cUTIs) Caused by ESBL Producing Gram Negative Bacteria (PLEA)
Randomized, Double-blind, Double-dummy, Active-controlled, Multi-centre Trial to Compare the Efficacy and Safety of CSE-1034 (Ceftriaxone+ Sulbactam+ EDTA) With Meropenem in Infections Caused by β-Lactamase (ESBL and MBL) Producing Gram-Negative Bacteria
Sponsor: Venus Remedies Limited
Listed as NCT03477422, this PHASE3 trial focuses on Acute Pyelonephritis and Urinary Tract Infection Complicated and remains completed. Sponsored by Venus Remedies Limited, it has been updated 7 times since 2014, reflecting limited change activity. This study is part of the global effort to build evidence for infectious disease interventions.
Status Flow
Change History
7 versions recorded-
Sep 2025 — Present [monthly]
Completed PHASE3
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Sep 2024 — Sep 2025 [monthly]
Completed PHASE3
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE3
-
Jan 2021 — Jul 2024 [monthly]
Completed PHASE3
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Sep 2019 — Jan 2021 [monthly]
Completed PHASE3
▶ Show 2 earlier versions
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Jun 2018 — Sep 2019 [monthly]
Completed PHASE3
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Apr 2018 — Jun 2018 [monthly]
Completed PHASE3
First recorded
Jan 2014
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Venus Remedies Limited
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Aligarh, India , Bangalore, India , Belagavi, India , Bikaner, India , Chandigarh, India , Lucknow, India , Ludhiana, India , New Delhi, India , Pune, India , Srinagar, India and 1 more location