Original Article
Clinical, microbial efficacy and tolerability of Elores, a novel antibiotic adjuvant entity in ESBL producing pathogens: Prospective randomized controlled clinical trial

https://doi.org/10.1016/j.jopr.2013.04.017Get rights and content

Abstract

Objective

To compare clinical and bacteriological efficacy as well as tolerability of ceftriaxone-sulbactam with adjuvant disodium edetate (the novel antibiotic adjuvant entity; Elores) in the treatment of skin and skin structure infections (SSSIs) and bone and joint infections (BJIs).

Methods

Patients were randomized into group A (ceftriaxone; n = 26 for SSSIs; n = 35 for BJIs) group B (Elores; n = 30 for SSSIs; n = 35 for BJIs). The patients were administered with Elores 3.0 g twice daily and ceftriaxone 2.0 g twice daily in two divided doses for 3–10 days.

Results

Out of the total population, percentage of clinically cured patients was 80.33% in Elores group and 30.77% in ceftriaxone group. However, 53.33% patients failed to respond to ceftriaxone in comparison to no clinical failure in Elores group at the end of therapy. There was 23.08% cumulative bacterial eradication in both indications BJIs and SSSIs of group A whereas a significantly higher 85.25% cumulative bacterial eradications was noted with group B in both indications. However, 58.46% cases failed to respond to ceftriaxone bacteriologically.

Conclusion

Results of this study indicates that Elores is more safe and effective regimen in treating ESBL producing gram-negative and gram-positive pathogens in comparison to plain ceftriaxone.

Keywords

Antibiotic adjuvant entity
Clinical trial
Phase-III
Elores

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