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Not yet recruitingNCT06815549Updated Feb 7, 2025

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"

A Phase 3 interventional study of Fluorothiazinone, tablets 300 mg and Nitrofurantoin 100 MG in P. Aeruginosa, Baumannii and Klebsiella Pneumonia, sponsored by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation. Not yet recruiting. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-07.

Sponsored by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 3
Study type
Interventional
Enrollment
280
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.
02

Conditions studied

  • P. Aeruginosa
  • Baumannii
  • Klebsiella Pneumonia
  • E.coli Infections
  • Enterococcus Faecalis Infection
  • Chronic Bacterial Cystitis
03

In context

Cystitis

69 studies on the registry are indexed under Cystitis; 17 are open to participants now.

This study's planned enrollment of 280 is above the median of 112 across 50 interventional studies indexed under Cystitis.

Browse Cystitis studies →

Lead sponsor

Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation is the lead sponsor of 41 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patient's written consent to participate in the study in accordance with the current legislation.
  2. The ability to understand the requirements for the study participants, the willingness to follow the procedures according to the Study Protocol.
  3. Female Patients, at least 18 years old.
  4. Ambulatory treatment, absence of indications for emergency hospitalization during the period of inclusion in the study for the infection under study.
  5. Bacterial cystitis, a history of chronic recurrent bladder infection.
  6. The presence of symptoms characteristic of exacerbation of chronic cystitis: pain syndrome (pain in the lower abdomen, when urinating), dysuric symptoms (frequent urination, pain or burning when urinating, imperative urge to urinate, feeling of incomplete emptying of the bladder). 6 points or higher when assessing the characteristic symptoms on the ACSS scale.
  7. Consent of patients with preserved to use effective methods of using one of the following methods: abstinence, intrauterine device, oral/ injectable contraceptive, subcutaneous implant or double barrier method (condom with local contraceptive) for the period of participation in the study.
  8. Negative pregnancy test result before randomization for female patients with preserved reproductive potential.

Exclusion criteria

Exclusion Criteria:

  1. Inability to read in Russian; inability or unwillingness to understand the essence of the research. Any other conditions that limit the validity of obtaining or may affect the volunteer's ability to participate in the study.
  2. Participation in any other study in the last 90 days;
  3. Presence of an infection of another organ other than a bladder infection, such as endocarditis, osteomyelitis, abscess, meningitis, pneumonia, etc.
  4. Symptoms requiring hospitalization (macrohematuria, concomitant diseases that complicate the course of the disease).
  5. Cystocele of 3-4 degrees.
  6. Treatment with Nitrofurantoin for 30 days before randomization.
  7. Mental illness (registered by a psychiatrist according to medical records).
  8. Treatment with hormonal drugs (with the exception of hormonal , hormone replacement therapy, topical medications) for the last 10 days.
  9. diseases or systemic connective tissue diseases in the anamnesis, requiring the appointment of therapy.
  10. Recipients of solid organs or tissues (bone marrow or peripheral blood stem cells).
  11. Taking immunosuppressive drugs and/or immunomodulators for 6 months prior to the start of the study.
  12. The presence of congenital or acquired immunodeficiency (AIDS, etc. according to medical history).
  13. History of malignant neoplasms, with the exception of basal cell or squamous cell epithelial carcinomas of the skin, which were removed without signs of more than 3 years ago.
  14. Blood donation (450 ml or more of blood or plasma) less than 2 months before the start of the study.
  15. Planned hospitalization and / or surgical intervention during the period of participation in the study, as well as 4 weeks before the expected date of drug administration.
  16. The presence of a concomitant disease that may affect the evaluation of the results of the study or which, in the opinion of the investigator, will not allow the patient to participate in the study or may affect the conduct of the study and / or its results (including the assessment of safety parameters), any conditions that, in the opinion of the medical investigator, may be a to participating in the study.
  17. Pregnancy or breast-feeding.
  18. Taking any long-acting systemic antibiotic (i.e., with a frequency of administration no more than once a day) for less than 12 hours before randomization.
  19. The need at the time of randomization for additional systemic antimicrobial therapy (including antibacterial, antifungal therapy) other than treatment with the drug, with the exception of a single oral administration of any antifungal drug for the treatment of vaginal candidiasis.
  20. Lactose intolerance, lactase deficiency or glucose-galactose malabsorption, allergy to the components of the studied drug / reference drug in the anamnesis.
  21. Contraindications to the use of Nitrofurantoin (severe renal excretory function disorders, renal insufficiency, oliguria, glucose-6-phosphate dehydrogenase deficiency, to Nitrofurantoin, stage II-III heart failure, liver cirrhosis, chronic hepatitis, acute porphyria).
Terms in these criteria, in plain language(9)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Reproductive potential

Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.

Criteria about it usually ask for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
280 participants (estimated)

Study arms

  • Experimental
    Drug: Fluorothiazinone, tablets 300 mg

    Treatment arm patients will receive Fluorothiazinone, tablets 300 mg at a dose 1200 mg/day (2 tablets twice a day) for 14 days.

    Drug: Fluorothiazinone, tablets 300 mg

  • Active comparator
    Comparator: Nitrofurantoin

    Comparison arm patients will receive Nitrofurantoin in accordance with the instructions for medical use.

    Drug: Nitrofurantoin 100 MG

Interventions

  • DrugFluorothiazinone, tablets 300 mg

    patients will receive Fluorothiazinone, tablets 300 mg at a dose 1200 mg/day (2 tablets twice a day) for 14 days

  • Comparison arm patients will receive Nitrofurantoin in accordance with the instructions for medical use.

06

What researchers measure

Primary outcomes

  1. AEs

    Occurrence of adverse events/reactions.

    Time frame: Within 90 days after administration of the drug.

  2. SAEs

    Occurrence of serious adverse events/reactions.

    Time frame: Within 90 days after administration of the drug.

  3. Complete resolution or improvement of the signs and symptoms of chronic cystitis

    Complete resolution or improvement of the signs and symptoms of chronic cystitis that were present at baseline, and the absence of new symptoms, that require further antimicrobial therapy.

    Time frame: 7th, 14th and 28th days after the start of therapy.

  4. Relapse

    Relapse of chronical bacterial cystitis monitoring.

    Time frame: Within 90 days from the start of therapy.

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Feb 2025; primary completion for Dec 2025, 10 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 3, 2025
First posted
Feb 7, 2025
StartEst.
Feb 17, 2025
Primary completionEst.
Dec 31, 2025
CompletionEst.
Dec 31, 2025
Last update
Feb 7, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06815549
Lead sponsor
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Responsible party
Sponsor
First posted
Feb 7, 2025
Start date
Feb 17, 2025 (estimated)
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Feb 7, 2025

Study contacts

N.F. Gamaleya NRCEM, Health Ministry of the Russian Federation
Contact
info@gamaleya.org
+7 (499) 193-30-01

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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