Evidence map›Paper›PMID 28376315›Full record

ArticleThe Brazilian journal of infectious diseases : an official publication of the Brazilian Society of Infectious Diseases

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.

Manu Chaudhary, Mohd Amin Mir, Shiekh Gazalla Ayub, Protocol 06 Group

Open access · goldAbstract read
In one paragraph

Article in The Brazilian journal of infectious diseases : an official publication of the Brazilian Society of Infectious Diseases. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
2.4field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 18 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
  4. Article
  5. Article
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors at 1 institution in 1 country.

Manu ChaudharyVenus Remedies, Department of Clinical Research, Panchkula, India.
Mohd Amin MirVenus Remedies, Department of Clinical Research, Panchkula, India. Electronic address: medcom@vmrcindia.com.
Shiekh Gazalla AyubVenus Remedies, Department of Clinical Research, Panchkula, India.
Protocol 06 GroupVenus Remedies, Department of Clinical Research, Panchkula, India.
Venus Remedies (India) · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.

Indexed as

AdultAgedAnti-Bacterial AgentsCeftriaxoneChildDisk Diffusion Antimicrobial TestsDrug CombinationsDrug Resistance, BacterialEdetic AcidGram-Negative BacteriaGram-Negative Bacterial InfectionsGram-Positive BacteriaGram-Positive Bacterial InfectionsHumansIndiaSulbactamAnti-Bacterial AgentsCeftriaxoneDrug CombinationsEdetic AcidSulbactamBacterial infectionsCSE-1034IPDMulti-drug resistance

Identifiers

PMID28376315
PMCPMC9427805
OpenAlexW2601263410

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.