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Novel antibiotic combo good alternative to carbapenems for complicated UTI
India: Researchers from India have developed CSE -- a novel combination of ceftriaxone, sulbactam, and disodium EDTA -- that can be used as an alternative to carbapenems for the patients suffering from complicated urinary tract infections (cUTI/AP) caused by resistant gram-negative pathogens, according to a randomized non-inferiority trial conducted in India. The findings are published in the Open Forum Infectious Diseases journal.CSE has activity against multidrug-resistant gram-negative pathogens.
The addition of sulbactam and disodium EDTA (a known metal chelator) have been shown to expand the in vitro activity of ceftriaxone against beta-lactamase-producing bacteria. CSE has been shown to demonstrate efficacy in animal infection models.
The phase 3 trial included 230 adults at 17 sites with a diagnosis of cUTI, including acute pyelonephritis. They were randomized in the ratio 1:1 to receive either intravenous CSE or intravenous meropenem.
The mMITT population consisted of 143 patients, with 74 receiving CSE and 69 receiving meropenem. Ceftriaxone non-susceptible pathogens were identified in 140 patients (97.9%), extended-spectrum beta-lactamase-producing pathogens in 119 (83.2%), and multidrug-resistant pathogens in 100 (69.9%).
Noninferiority of CRE to meropenem was demonstrated for both of the US Food and Drug Administration–defined co-primary endpoints.
Key findings include:
- Seventy-one of 74 patients (95.9%) in the CSE group showed symptomatic resolution at test-of-cure, compared with 62 of 69 patients (89.9%) in the meropenem group (treatment difference, 6 percentage points), and 70 of 74 patients (94.6%) in the CSE group showed both symptomatic resolution and microbiologic eradication at test-of-cure, compared with 60 of 69 (87.0%) patients (treatment difference, 7.6 percentage points)
- Non-inferiority was also demonstrated for the European Medicine Agency primary endpoint (microbiologic eradication at test-of-cure).
- The safety profile of CSE was consistent with that of ceftriaxone alone.
"The results support the use of CSE as a potential alternative to carbapenems in the treatment of patients with cUTI or acute pyelonephritis, including infections caused by extended-spectrum beta-lactamase-producing gram-negative bacteria," concluded the authors.
The bottom line is -- CSE can be used in place of carbapenems for the treatment of cUTI caused by multidrug-resistant gram-negative pathogens.
To read the complete study log on to https://doi.org/10.1093/ofid/ofz373
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