Delving into the Latest Updates on Ceftriaxone Sodium/Sulbactam Sodium/Edetic Acid with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Ceftriaxone/EDTA/sulbactam, Ceftriaxone/disodium-edetate/sulbactam, Ceftriaxone/sulbactam/edetic acid Remedies

+ [3]

Target

PBPs x β-lactamase

Action

inhibitors

Mechanism

PBPs inhibitors(Bacterial penicillin-binding protein inhibitors), β-lactamase inhibitors(Beta Lactamase inhibitors), Cell wall inhibitors

Therapeutic Areas

Infectious Diseases

Active Indication

Bacterial Infections

Inactive Indication

Acute pyelonephritisComplicated urinary tract infectionGram-Negative Bacterial Infections

Originator Organization

Venus Remedies Ltd.

Active Organization

Venus Remedies Ltd.

Inactive Organization-

License Organization

Venus Remedies Ltd.

Cipla Ltd.

Drug Highest PhaseApproved

First Approval Date

India (01 Jan 2011),

Bacterial Infections

Regulation-

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Structure/Sequence

Molecular FormulaC10H16N2O8

InChIKeyKCXVZYZYPLLWCC-UHFFFAOYSA-N

CAS Registry60-00-4

View All Structures (3)

India is well known for the rampant growth of ESBLs that jeopardized the clinical utility of standalone beta-lactam. Pharmaceutical organizations fancied to rescue these beta-lactams by combining them with generic beta-lactamase inhibitors despite such combinations were never investigated in non-clinical or clinical studies. Lack of stringency in regulatory review practices allowed the market entry of these combinations. CSE 1034 (ceftriaxone, sulbactam and EDTA) and cefoperazone sulbactam are the most irrational antibiotics in clinical use. The effectiveness of such combinations relies on multiple factors such as relative beta-lactamase stability of the standalone beta-lactam, the inhibitory potency of the beta-lactamase inhibitor and more importantly the adequacy of the dose incorporated in the formulation. Unfortunately, none of the unconventional BL-BLI inhibitor combinations marketed in India has been subjected to such evaluations. Therefore, their therapeutic utility is uncertain. Besides questionable therapeutic utility, sub-optimal exposures would lead to the selection of resistant clones.

01 Sep 2018·Journal of Infection and Public HealthQ3 · MEDICINE

Comparative efficacy and safety analysis of CSE-1034: An open labeled phase III study in community acquired pneumonia

Q3 · MEDICINE

ArticleOA

Author: Chaudhary, Manu ; Ayub, Shiekh G ; Mir, Mohd A

OBJECTIVECSE-1034 is a novel antibiotic adjuvant entity (AAE) with proven activity against broad range of multi-drug resistant (MDR) pathogens causing various bacterial infections. This phase 3 clinical trial was designed to evaluate the efficacy and safety of CSE-1034 therapy for the treatment of community-acquired pneumonia (CAP) patients of Pneumonia Outcomes Research Team (PORT) risk III-IV.METHODSIn this multi-centric, controlled, open-labeled phase 3 trial, adult patients with PORT risk III-IV CAP were randomized to receive either intravenous CSE-1034 (3g every 12h) or Ceftriaxone (2g every 12h) for 3-10 days. The primary endpoint was clinical response in clinically-evaluable (CE) population and microbiological eradication in microbiologically-evaluable (ME) population at test of cure (TOC) visits. Secondary endpoints included verification of the primary endpoints across all other visits, treatment duration and safety of patients.RESULTS156 patients were screened at 5 study centers of which 93 subjects were enrolled in the study and randomized in CSE-1034 and Ceftriaxone treatment arms. In CE population (n=90), the clinical cure rates at TOC visit were 96% and 64% in CSE-1034 (n=46) and Ceftriaxone (n=44) treatment arms respectively (treatment difference: 32.0%; 95% CI, 15.8%-47.1%). The bacterial eradication in ME population of two treatment arms were 94% (n=36) and 56% (n=27) at TOC visit (treatment difference: 38.9%; 95% CI, 17.8%-57.6%). Overall, the total number of adverse events (AEs) reported in both groups were 21 (22.5%). The AEs rates reported in two treatment arms were 15.2% in CSE-1034 and 29.8% in Ceftriaxone group.CONCLUSIONOverall assessment of clinical cure rate, microbiological eradication rate and safety assessment in this study has shown that CSE-1034 is an effective and safe option for the treatment of CAP patients of PORT risk III-IV. Moreover, the superiority of CSE-1034 over Ceftriaxone is also proven.

01 Jan 2018·Journal of Global Infectious Diseases

CSE-1034 versus ceftriaxone: Efficacy and safety analysis from a randomized, open-labeled phase III study in complicated urinary tract infections

Article

Author: Ayub, Shiekh Gazalla ; Mir, Mohd Amin ; Chaudhary, Manu

OBJECTIVEThe aim of this study was to determine the clinical outcome, microbiological outcome and safety profile of CSE-1034, a novel combination of Ceftriaxone, Sulbactam and EDTA in patients with complicated urinary tract infections (cUTI).MATERIALS AND METHODSThis was a randomized, controlled, open-labeled Phase-3 trial with the primary objective of assessing the efficacy and safety of CSE-1034 versus Ceftriaxone for the empirical treatment of cUTI. Adult cUTI patients were randomized to receive either intravenous dose of CSE-1034 or Ceftriaxone. The primary end point was composite cure rate (clinical response and bacterial eradication) in mMITT population at test of cure (TOC) visit. Secondary measures included verification of primary endpoint across other visits in different population sets, safety of patients and treatment duration.RESULTSOverall, 204 patients were enrolled in the study and received one of the two treatments. At primary endpoint (TOC visit), the composite cure rate was much higher in CSE-1034 treatment arm compared to Ceftriaxone arm i.e. 97% (68/70) vs 83% (58/71) (treatment difference 12.6%; 95% CI: 5.9% to 26.4%). The adverse events (AEs) rates reported in two treatment arms were 21% in CSE-1034 and 36% in Ceftriaxone groups. Additionally, the treatment duration in CSE-1034 arm was significantly less (P < 0.05).CONCLUSIONSCSE-1034 3 g every 24 h showed a high favorable clinical and bacteriological response, and 95% CI around the treatment difference prove the superiority of CSE-1034 vs. Ceftriaxone for the treatment of cUTI. Therefore, CSE-1034 provides an effective alternative in the treatment of patients with cUTI.

100 Deals associated with Ceftriaxone Sodium/Sulbactam Sodium/Edetic Acid

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External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Bacterial Infections	India	Venus Remedies Ltd.	01 Jan 2011

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute pyelonephritis	Discovery	India	Venus Remedies Ltd.	11 Jan 2014
Complicated urinary tract infection	Discovery	India	Venus Remedies Ltd.	11 Jan 2014
Gram-Negative Bacterial Infections	Discovery	India	Venus Remedies Ltd.	11 Jan 2014