PMID- 30581259
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220330
IS  - 0974-777X (Print)
IS  - 0974-8245 (Electronic)
IS  - 0974-777X (Linking)
VI  - 10
IP  - 4
DP  - 2018 Oct-Dec
TI  - CSE-1034 versus Ceftriaxone: Efficacy and Safety Analysis from a Randomized, 
      Open-labeled Phase III Study in Complicated Urinary Tract Infections.
PG  - 188-195
LID - 10.4103/jgid.jgid_98_17 [doi]
AB  - OBJECTIVE: The 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 METHODS: This 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. 
      RESULTS: Overall, 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). CONCLUSIONS: CSE-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.
FAU - Chaudhary, Manu
AU  - Chaudhary M
AD  - Department of Clinical Research, Venus Remedies, Panchkula, Haryana, India.
FAU - Ayub, Shiekh Gazalla
AU  - Ayub SG
AD  - Department of Clinical Research, Venus Remedies, Panchkula, Haryana, India.
FAU - Mir, Mohd Amin
AU  - Mir MA
AD  - Department of Clinical Research, Venus Remedies, Panchkula, Haryana, India.
CN  - Members of Study Group
LA  - eng
PT  - Journal Article
PL  - India
TA  - J Glob Infect Dis
JT  - Journal of global infectious diseases
JID - 101521436
PMC - PMC6276312
OTO - NOTNLM
OT  - CSE-1034
OT  - Ceftriaxone
OT  - anti-microbial resistance
OT  - cUTI
COIS- Manu Chaudhary, Shiekh Gazalla Ayub and Mohd Amin Mir are the employees of Venus 
      Remedies, Panchkula. All other authors declare that they have no conflict of 
      interest.
EDAT- 2018/12/26 06:00
MHDA- 2018/12/26 06:01
PMCR- 2018/10/01
CRDT- 2018/12/25 06:00
PHST- 2018/12/25 06:00 [entrez]
PHST- 2018/12/26 06:00 [pubmed]
PHST- 2018/12/26 06:01 [medline]
PHST- 2018/10/01 00:00 [pmc-release]
AID - JGID-10-188 [pii]
AID - 10.4103/jgid.jgid_98_17 [doi]
PST - ppublish
SO  - J Glob Infect Dis. 2018 Oct-Dec;10(4):188-195. doi: 10.4103/jgid.jgid_98_17.