NCT06815549

An Open Clinical Trial of the Safety and Efficacy of the Drug Fluorothiazinone, 300 Mg Tablets with the Participation of Adult Patients with Chronic Bacterial Cystitis"

An Open Clinical Trial of the Safety and Efficacy of the Drug Fluorothiazinone, 300 Mg Tablets (Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation) with the Participation of Adult Patients with Chronic Bacterial Cystitis"

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 280 (estimated)
• Sponsor: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to evaluate the safety, clinical efficacy and antibacterial activity of the drug Fluorothiazinone, 300 mg tablets, (Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation) in the mode of antibacterial monotherapy with the participation of adult patients with chronic bacterial cystitis. The main objectives of this study are: 1. To evaluate the safety of the use of the drug Fluorothiazinone according to the indicators 1. adverse events/reactions; 2. serious adverse events/reactions; 3. deviations from clinical and laboratory parameters. 2. To evaluate the therapy effectiveness: 1. clinical cure - complete resolution or improvement of the signs and symptoms of chronic cystitis that were present at baseline and the absence of new symptoms requiring antimicrobial therapy on days 7, 14 and 28 after the start of therapy; 2. the timing of the disappearance of symptoms according to the patient's subjective feelings; 3. microbiological response when comparing pre-treatment and post-treatment cultures; 4. changes on VAS (visual analogue scale) for pain intensity determination; 5. changes on PUF (Pelvic pain and urgency/frequency patient symptom scale) for assessing symptoms by patients; 6. changes on ACSS (acute cystitis symptom scale); 7. development of relapses within 90 days after the start of therapy. 3. To collect clinical isolates of pathogens for molecular genetic analysis. The identification of DNA and the determination of the bacterial genotype will allow us to assess the microbiological outcomes such as relapse or reinfection. 4. To determine the sensitivity of the obtained isolates to antibiotics.

Conditions

• P. Aeruginosa
• Baumannii
• Klebsiella Pneumonia
• E.coli Infections
• Enterococcus Faecalis Infection
• Chronic Bacterial Cystitis

Interventions

Type	Name	Description
DRUG	Fluorothiazinone, tablets 300 mg	patients will receive Fluorothiazinone, tablets 300 mg at a dose 1200 mg/day (2 tablets twice a day) for 14 days
DRUG	Nitrofurantoin 100 MG	Comparison arm patients will receive Nitrofurantoin in accordance with the instructions for medical use.

Timeline

• Start date: 2025-02-17
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2025-02-07
• Last updated: 2025-02-07