PMID- 28376315
OWN - NLM
STAT- MEDLINE
DCOM- 20170825
LR  - 20220902
IS  - 1678-4391 (Electronic)
IS  - 1413-8670 (Print)
IS  - 1413-8670 (Linking)
VI  - 21
IP  - 4
DP  - 2017 Jul-Aug
TI  - 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.
PG  - 408-417
LID - S1413-8670(16)30463-9 [pii]
LID - 10.1016/j.bjid.2017.02.007 [doi]
AB  - OBJECTIVE: In 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. METHODS: This 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. RESULTS: A 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. CONCLUSION: In 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.
CI  - Copyright (c) 2017 Sociedade Brasileira de Infectologia. Published by Elsevier 
      Editora Ltda. All rights reserved.
FAU - Chaudhary, Manu
AU  - Chaudhary M
AD  - Venus Remedies, Department of Clinical Research, Panchkula, India.
FAU - Mir, Mohd Amin
AU  - Mir MA
AD  - Venus Remedies, Department of Clinical Research, Panchkula, India. Electronic 
      address: medcom@vmrcindia.com.
FAU - Ayub, Shiekh Gazalla
AU  - Ayub SG
AD  - Venus Remedies, Department of Clinical Research, Panchkula, India.
CN  - Protocol 06 Group
AD  - Venus Remedies, Department of Clinical Research, Panchkula, India.
LA  - eng
PT  - Journal Article
DEP - 20170401
PL  - Brazil
TA  - Braz J Infect Dis
JT  - The Brazilian journal of infectious diseases : an official publication of the 
      Brazilian Society of Infectious Diseases
JID - 9812937
RN  - 0 (Anti-Bacterial Agents)
RN  - 0 (Drug Combinations)
RN  - 75J73V1629 (Ceftriaxone)
RN  - 9G34HU7RV0 (Edetic Acid)
RN  - S4TF6I2330 (Sulbactam)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Anti-Bacterial Agents/administration & dosage/adverse effects/chemistry
MH  - Ceftriaxone/administration & dosage/adverse effects
MH  - Child
MH  - Disk Diffusion Antimicrobial Tests
MH  - Drug Combinations
MH  - Drug Resistance, Bacterial
MH  - Edetic Acid/administration & dosage/adverse effects
MH  - Gram-Negative Bacteria/classification/*drug effects
MH  - Gram-Negative Bacterial Infections/drug therapy/*microbiology
MH  - Gram-Positive Bacteria/classification/*drug effects
MH  - Gram-Positive Bacterial Infections/drug therapy/*microbiology
MH  - Humans
MH  - India
MH  - Sulbactam/administration & dosage/adverse effects
PMC - PMC9427805
OTO - NOTNLM
OT  - Bacterial infections
OT  - CSE-1034
OT  - IPD
OT  - Multi-drug resistance
EDAT- 2017/04/05 06:00
MHDA- 2017/08/26 06:00
PMCR- 2017/04/01
CRDT- 2017/04/05 06:00
PHST- 2016/11/01 00:00 [received]
PHST- 2017/01/30 00:00 [revised]
PHST- 2017/02/04 00:00 [accepted]
PHST- 2017/04/05 06:00 [pubmed]
PHST- 2017/08/26 06:00 [medline]
PHST- 2017/04/05 06:00 [entrez]
PHST- 2017/04/01 00:00 [pmc-release]
AID - S1413-8670(16)30463-9 [pii]
AID - 10.1016/j.bjid.2017.02.007 [doi]
PST - ppublish
SO  - Braz J Infect Dis. 2017 Jul-Aug;21(4):408-417. doi: 10.1016/j.bjid.2017.02.007. 
      Epub 2017 Apr 1.