Journal: Journal of Pharmacy Research

Article Id: JPRS-PB-00001290
Title: A randomized, open-label, prospective, multicenter phase-III clinical trial of Elores in lower respiratory tract and urinary tract infections
Category: Pharmaceutical Biotechnology
Section: Research Article
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    Background: Lower respiratory tract infections (LTRIs) and urinary tract infections (UTIs) are the leading causes of death world-wide. Treatment of these infections require the use of antibiotics with enhanced activity against a broad spectrum of respiratory and urinary pathogens. This study was designed to study clinical and bacteriological efficacy as well as tolerability of ceftiaxone þ disodium edtate þ sulbactam (the novel Antibiotic Adjuvant Entity; Elores) in adult patients in the treatment of lower respiratory tract infections (LRTIs) and urinary tract infections (UTIs). Methods: A randomized, open-label, multicenter study was conducted on 297 patients which included 204 in UTIs and 93 in LRTIs. A total of 148 patients were there in Elores group with 102 cases of UTIs and 46 LRTIs; 149 in ceftriaxone group with 102 cases of UTIs and 47 LRTIs. The patients received 3e10 days of treatment with Elores 3.0 g twice daily and ceftriaxone 2.0 g twice daily in two divided doses. Results and discussion: Clinical cure rates in ITT (Intend to treat) populations of Elores were 83.33% (85/102), 91.30% (42/46) in the UTIs and LRTIs, respectively, and 34.31% (35/102), 31.91% (15/47) in the ceftriaxone group for UTIs and LRTIs, respectively. The corresponding bacterial eradication rates were 95% (57/60) and 97.05% (33/34) for Elores in the UTIs and LRTIs, respectively and 80.64% (50/62) and 71.42% (10/14) for ceftriaxone in the UTIs and LRTIs, respectively. Adverse reaction were observed in 20.59% (21/102) and 15.22% (7/46) in Elores groups of UTIs and LRTIs, respectively and 36.27% (37/102) and 31.91% (14/47) in ceftriaxone groups of UTIs and LRTIs, respectively. Conclusions: Results obtained in the present study, together with microbiological evaluation data suggest that Elores is more effective and safe antibacterial agent for the treatment of LRTIs and UTIs infections

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    Author(s) Name:

    Manu Chaudhary, Anurag Payasi*

    Affiliation(s) Name:

    Department of Cell Culture and Molecular Biology, Venus Medicine Research Centre, Baddi, Bhatoli Kalan, H.P 173205, India

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    Author:

    Manu Chaudhary, Anurag Payasi*

    Title:A randomized, open-label, prospective, multicenter phase-III clinical trial of Elores in lower respiratory tract and urinary tract infections
    Journal:Journal of Pharmacy Research
    Vol(issue):6 (April)
    Year:2013
    Page No: (404-414)

  • Experimental Methods Keywords

    Methodology:Clinical trial,Phase-III
    Research Materials:Elores

Keywords

Antibiotic adjuvant entity Clinical trial Elores Phase-III

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