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

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-

Drug Highest PhaseApproved

First Approval Date

IN (01 Jan 2011),

Bacterial Infections

Regulation-

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Structure

Molecular FormulaC10H16N2O8

InChIKeyKCXVZYZYPLLWCC-UHFFFAOYSA-N

CAS Registry60-00-4

View All Structures (3)

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.

01 Jul 2017·The Brazilian Journal of Infectious DiseasesQ4 · MEDICINE

Safety and efficacy of a novel drug elores (ceftriaxone + sulbactam + disodium edetate) in the management of multi-drug resistant bacterial infections in tertiary care centers: a post-marketing surveillance study

Q4 · MEDICINE

ArticleOA

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

OBJECTIVEIn India, Elores (CSE-1034: ceftriaxone+sulbactam+disodium edetate) was approved as a broad spectrum antibiotic in year 2011 and is used for management of Extended Spectrum Beta Lactamases/Metallo Beta lactamases infections in tertiary care centers. The objective of this study was to investigate the efficacy of this drug in patients with Extended Spectrum Beta Lactamases/Metallo Beta lactamases infections and identify the incidence of adverse events in real clinical settings.METHODSThis Post Marketing Surveillance study was conducted at 17 centers across India and included 2500 patients of all age groups suffering from various bacterial infections and treated with Elores (CSE1034). Information regarding demographic, clinical and microbiological parameters, dosage and treatment duration, efficacy and adverse events (AEs) associated with the treatment were recorded.RESULTSA total of 2500 patients were included in the study and efficacy was evaluated in 2487 patients. In total, 409 AEs were reported in 211 (8.4%) patients. The major AEs reported were vomiting (3.0%), pain at injection site (2.5%), nausea (2.3%), redness at site (1.96%), thrombophlebitis (1.4%). Of total reported AEs, 40 (5.3%) AEs were reported in pediatric, 310 (20.6%) in adult, and 59 (23.6%) in geriatric group. No AE belonging to grade IV or V was reported in any patient. In terms of efficacy, 1977 (79.4%) patients were cured, 501 (20.1%) patients showed clinical improvement and 5 (0.2%) patients were complete failure. The treatment duration varied from 5 to 7 days in different patients depending on the infection type.CONCLUSIONIn this post-marketing surveillance study, CSE-1034 was found to be an effective and safe option against Pip tazo and meropenem in management of patients with multi-drug resistant (MDR) bacterial infections under routine ward settings.

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	IN	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	IN	Venus Remedies Ltd.	11 Jan 2014
Complicated urinary tract infection	Discovery	IN	Venus Remedies Ltd.	11 Jan 2014
Gram-Negative Bacterial Infections	Discovery	IN	Venus Remedies Ltd.	11 Jan 2014