A New “Non-Traditional” Antibacterial Drug Fluorothiazinone—Clinical Research in Patients with Complicated Urinary Tract Infections
Nailya A. Zigangirova,
Nadezda L. Lubenec,
Vladimir B. Beloborodov,
Anna B. Sheremet,
Stanislava A. Nelyubina,
Nataliia E. Bondareva,
Konstantin A. Zakharov,
Sergey I. Luyksaar,
Sergey A. Zolotov,
Evgenia U. Levchenko,
Svetlana V. Luyksaar,
Ekaterina A. Koroleva,
Elena D. Fedina,
Yana V. Simakova,
Dmitry Yu. Pushkar,
Alexander L. Gintzburg
Affiliations
Nailya A. Zigangirova
National Research Center for Epidemiology and Microbiology named after the Honorary Academician N. F. Gamaleya, 18 Gamaleya St., 123098 Moscow, Russia
Nadezda L. Lubenec
National Research Center for Epidemiology and Microbiology named after the Honorary Academician N. F. Gamaleya, 18 Gamaleya St., 123098 Moscow, Russia
Vladimir B. Beloborodov
National Research Center for Epidemiology and Microbiology named after the Honorary Academician N. F. Gamaleya, 18 Gamaleya St., 123098 Moscow, Russia
Anna B. Sheremet
National Research Center for Epidemiology and Microbiology named after the Honorary Academician N. F. Gamaleya, 18 Gamaleya St., 123098 Moscow, Russia
Stanislava A. Nelyubina
National Research Center for Epidemiology and Microbiology named after the Honorary Academician N. F. Gamaleya, 18 Gamaleya St., 123098 Moscow, Russia
Nataliia E. Bondareva
National Research Center for Epidemiology and Microbiology named after the Honorary Academician N. F. Gamaleya, 18 Gamaleya St., 123098 Moscow, Russia
Konstantin A. Zakharov
Accellena LLC, 88, lit.A., Sredniy pr. V.O., 199106 St. Petersburg, Russia
Sergey I. Luyksaar
National Research Center for Epidemiology and Microbiology named after the Honorary Academician N. F. Gamaleya, 18 Gamaleya St., 123098 Moscow, Russia
Sergey A. Zolotov
National Research Center for Epidemiology and Microbiology named after the Honorary Academician N. F. Gamaleya, 18 Gamaleya St., 123098 Moscow, Russia
Evgenia U. Levchenko
National Research Center for Epidemiology and Microbiology named after the Honorary Academician N. F. Gamaleya, 18 Gamaleya St., 123098 Moscow, Russia
Svetlana V. Luyksaar
National Research Center for Epidemiology and Microbiology named after the Honorary Academician N. F. Gamaleya, 18 Gamaleya St., 123098 Moscow, Russia
Ekaterina A. Koroleva
National Research Center for Epidemiology and Microbiology named after the Honorary Academician N. F. Gamaleya, 18 Gamaleya St., 123098 Moscow, Russia
Elena D. Fedina
National Research Center for Epidemiology and Microbiology named after the Honorary Academician N. F. Gamaleya, 18 Gamaleya St., 123098 Moscow, Russia
Yana V. Simakova
National Research Center for Epidemiology and Microbiology named after the Honorary Academician N. F. Gamaleya, 18 Gamaleya St., 123098 Moscow, Russia
Dmitry Yu. Pushkar
Department of Urology Russian University of Medicine of the Ministry of Healthcare of the Russian Federation, 4 Dolgorukovskaya St., 127006 Moscow, Russia
Alexander L. Gintzburg
National Research Center for Epidemiology and Microbiology named after the Honorary Academician N. F. Gamaleya, 18 Gamaleya St., 123098 Moscow, Russia
In order to combat resistance, it is necessary to develop antimicrobial agents that act differently from conventional antibiotics. Fluorothiazinone, 300 mg tablet (The Gamaleya National Research Center), is an original antibacterial drug based on a new small molecule T3SS and flagellum inhibitor. A total of 357 patients with complicated urinary tract infections (UTIs) were divided into two groups and given Fluorothiazinone 1200 mg/day or a placebo for 7 days to evaluate the efficacy and safety of the drug. Additionally, all patients were given Cefepime 2000 mg/day. Fluorothiazinone with Cefepime showed superiority over placebo/Cefepime based on the assessment of the proportion of patients with an overall outcome in the form of a cure after 21 days post-therapy (primary outcome), overall outcome in cure rates, clinical cure rates, and microbiological efficacy at the end of therapy and after 21 days post-therapy (secondary outcomes). In patients who received Fluorothiazinone, the rate of infection recurrences 53 and 83 days after the end of the therapy was lower by 18.9%, compared with patients who received placebo. Fluorothiazinone demonstrated a favorable safety profile with no serious unexpected adverse events reported. The results showed superiority of the therapy with Fluorothiazinone in combination with Cefepime compared with placebo/Cefepime in patients with cUTIs.