PMID- 29803638
OWN - NLM
STAT- MEDLINE
DCOM- 20181106
LR  - 20220330
IS  - 1876-035X (Electronic)
IS  - 1876-0341 (Linking)
VI  - 11
IP  - 5
DP  - 2018 Sep-Oct
TI  - Comparative efficacy and safety analysis of CSE-1034: An open labeled phase III 
      study in community acquired pneumonia.
PG  - 691-697
LID - S1876-0341(18)30042-X [pii]
LID - 10.1016/j.jiph.2018.04.006 [doi]
AB  - OBJECTIVE: CSE-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. METHODS: In 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. RESULTS: 156 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. CONCLUSION: Overall 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.
CI  - Copyright (c) 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.
FAU - Chaudhary, Manu
AU  - Chaudhary M
AD  - Department of Clinical Research, Venus Remedies, Panchkula, 134114, India.
FAU - Ayub, Shiekh G
AU  - Ayub SG
AD  - Department of Clinical Research, Venus Remedies, Panchkula, 134114, India.
FAU - Mir, Mohd A
AU  - Mir MA
AD  - Department of Clinical Research, Venus Remedies, Panchkula, 134114, India. 
      Electronic address: medcom@vmrcindia.com.
CN  - protocol 05 group
AD  - Department of Clinical Research, Venus Remedies, Panchkula, 134114, India.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20180524
PL  - England
TA  - J Infect Public Health
JT  - Journal of infection and public health
JID - 101487384
RN  - 0 (Anti-Bacterial Agents)
RN  - 75J73V1629 (Ceftriaxone)
SB  - IM
MH  - Administration, Intravenous
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Anti-Bacterial Agents/*administration & dosage/*adverse effects
MH  - Ceftriaxone/administration & dosage/adverse effects
MH  - Community-Acquired Infections/*drug therapy
MH  - Drug-Related Side Effects and Adverse Reactions/epidemiology/pathology
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Pneumonia/*drug therapy
MH  - Treatment Outcome
MH  - Young Adult
OTO - NOTNLM
OT  - Anti-microbial resistance
OT  - CAP
OT  - CSE-1034
OT  - Ceftriaxone
EDAT- 2018/05/29 06:00
MHDA- 2018/11/07 06:00
CRDT- 2018/05/28 06:00
PHST- 2017/08/08 00:00 [received]
PHST- 2018/02/21 00:00 [revised]
PHST- 2018/04/08 00:00 [accepted]
PHST- 2018/05/29 06:00 [pubmed]
PHST- 2018/11/07 06:00 [medline]
PHST- 2018/05/28 06:00 [entrez]
AID - S1876-0341(18)30042-X [pii]
AID - 10.1016/j.jiph.2018.04.006 [doi]
PST - ppublish
SO  - J Infect Public Health. 2018 Sep-Oct;11(5):691-697. doi: 
      10.1016/j.jiph.2018.04.006. Epub 2018 May 24.