P. AeruginosaPhase 3NCT06815549
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 study testing Fluorothiazinone, tablets 300 mg and Nitrofurantoin 100 MG in people with P. Aeruginosa and Baumannii, run by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- P. Aeruginosa, Baumannii, Klebsiella Pneumonia
- What is being tested?
- Fluorothiazinone, tablets 300 mg and Nitrofurantoin 100 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- No sites listed yet
- Study dates
- 17 Feb 2025to 31 Dec 2025
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient's written consent to participate in the study in accordance with the current legislation.
- The ability to understand the requirements for the study participants, the willingness to follow the procedures according to the Study Protocol.
- Female Patients, at least 18 years old.
- Ambulatory treatment, absence of indications for emergency hospitalization during the period of inclusion in the study for the infection under study.
- Bacterial cystitis, a history of chronic recurrent bladder infection.
- 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.
- Consent of patients with preserved reproductive potential to use effective methods of contraception 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.
- Negative pregnancy test result before randomization for female patients with preserved reproductive potential.
Who cannot join
- Inability to read in Russian; inability or unwillingness to understand the essence of the research. Any other conditions that limit the validity of obtaining informed consent or may affect the volunteer's ability to participate in the study.
- Participation in any other study in the last 90 days;
- Presence of an infection of another organ other than a bladder infection, such as endocarditis, osteomyelitis, abscess, meningitis, pneumonia, etc.
- Symptoms requiring hospitalization (macrohematuria, concomitant diseases that complicate the course of the disease).
- Cystocele of 3-4 degrees.
- Treatment with Nitrofurantoin for 30 days before randomization.
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- Mental illness (registered by a psychiatrist according to medical records).
- Treatment with hormonal drugs (with the exception of hormonal contraceptives, hormone replacement therapy, topical medications) for the last 10 days.
- Autoimmune diseases or systemic connective tissue diseases in the anamnesis, requiring the appointment of immunosuppressive therapy.
- Recipients of solid organs or tissues (bone marrow or peripheral blood stem cells).
- Taking immunosuppressive drugs and/or immunomodulators for 6 months prior to the start of the study.
- The presence of congenital or acquired immunodeficiency (AIDS, etc. according to medical history).
- History of malignant neoplasms, with the exception of basal cell or squamous cell epithelial carcinomas of the skin, which were removed without signs of metastasis more than 3 years ago.
- Blood donation (450 ml or more of blood or plasma) less than 2 months before the start of the study.
- 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.
- 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 contraindication to participating in the study.
- Pregnancy or breast-feeding.
- 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.
- The need at the time of randomization for additional systemic antimicrobial therapy (including antibacterial, antifungal therapy) other than treatment with the investigational drug, with the exception of a single oral administration of any antifungal drug for the treatment of vaginal candidiasis.
- Lactose intolerance, lactase deficiency or glucose-galactose malabsorption, allergy to the components of the studied drug / reference drug in the anamnesis.
- Contraindications to the use of Nitrofurantoin (severe renal excretory function disorders, renal insufficiency, oliguria, glucose-6-phosphate dehydrogenase deficiency, hypersensitivity to Nitrofurantoin, stage II-III heart failure, liver cirrhosis, chronic hepatitis, acute porphyria).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
N.F. Gamaleya NRCEM, Health Ministry of the Russian Federation contact
About this study
Official title: 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"
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:
- To evaluate the safety of the use of the drug Fluorothiazinone according to the indicators
- adverse events/reactions;
- serious adverse events/reactions;
- deviations from clinical and laboratory parameters.
- To evaluate the therapy effectiveness:
- 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;
- the timing of the disappearance of symptoms according to the patient's subjective feelings;
- microbiological response when comparing pre-treatment and post-treatment cultures;
- changes on VAS (visual analogue scale) for pain intensity determination;
- changes on PUF (Pelvic pain and urgency/frequency patient symptom scale) for assessing symptoms by patients;
- changes on ACSS (acute cystitis symptom scale);
- development of relapses within 90 days after the start of therapy.
- 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.
- 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
- Being tested
- Fluorothiazinone, tablets 300 mg, Nitrofurantoin 100 MG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluorothiazinone, tablets 300 mgDrug
patients will receive Fluorothiazinone, tablets 300 mg at a dose 1200 mg/day (2 tablets twice a day) for 14 days
Nitrofurantoin 100 MGDrug
Comparison arm patients will receive Nitrofurantoin in accordance with the instructions for medical use.
| Study group | Role | What they receive |
|---|---|---|
| Drug: Fluorothiazinone, tablets 300 mg | Experimental | Treatment arm patients will receive Fluorothiazinone, tablets 300 mg at a dose 1200 mg/day (2 tablets twice a day) for 14 days. Receives: Drug: Fluorothiazinone, tablets 300 mg |
| Comparator: Nitrofurantoin | Active comparator | Comparison arm patients will receive Nitrofurantoin in accordance with the instructions for medical use. Receives: Drug: Nitrofurantoin 100 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
AEs
Occurrence of adverse events/reactions.
Measured: Within 90 days after administration of the drug.
SAEs
Occurrence of serious adverse events/reactions.
Measured: Within 90 days after administration of the drug.
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.
Measured: 7th, 14th and 28th days after the start of therapy.
Relapse
Relapse of chronical bacterial cystitis monitoring.
Measured: Within 90 days from the start of therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start17 Feb 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for P. AeruginosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06815549
- Sponsor's protocol ID
- 07-FT-2024
- Status last verified
- Feb 2025
- First submitted
- 3 Feb 2025
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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"
- ClinicalTrials.gov ID
- NCT06815549
- Acronym / sponsor ID
- 07-FT-2024
- Conditions
- P. Aeruginosa, Baumannii, Klebsiella Pneumonia, E.coli Infections, Enterococcus Faecalis Infection, Chronic Bacterial Cystitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian FederationUniversity, hospital or other
- Study start
- 17 Feb 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 7 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To evaluate the safety of the use of the drug Fluorothiazinone according to the indicators
- adverse events/reactions;
- serious adverse events/reactions;
- deviations from clinical and laboratory parameters.
- To evaluate the therapy effectiveness:
- 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;
- the timing of the disappearance of symptoms according to the patient's subjective feelings;
- microbiological response when comparing pre-treatment and post-treatment cultures;
- changes on VAS (visual analogue scale) for pain intensity determination;
- changes on PUF (Pelvic pain and urgency/frequency patient symptom scale) for assessing symptoms by patients;
- changes on ACSS (acute cystitis symptom scale);
- development of relapses within 90 days after the start of therapy.
- 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.
- To determine the sensitivity of the obtained isolates to antibiotics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug: Fluorothiazinone, tablets 300 mg | Experimental | Drug: Fluorothiazinone, tablets 300 mgTreatment arm patients will receive Fluorothiazinone, tablets 300 mg at a dose 1200 mg/day (2 tablets twice a day) for 14 days. |
| Comparator: Nitrofurantoin | Active comparator | Drug: Nitrofurantoin 100 MGComparison arm patients will receive Nitrofurantoin in accordance with the instructions for medical use. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient's written consent to participate in the study in accordance with the current legislation.
- The ability to understand the requirements for the study participants, the willingness to follow the procedures according to the Study Protocol.
- Female Patients, at least 18 years old.
- Ambulatory treatment, absence of indications for emergency hospitalization during the period of inclusion in the study for the infection under study.
- Bacterial cystitis, a history of chronic recurrent bladder infection.
Key exclusion criteria (21 listed)
- Inability to read in Russian; inability or unwillingness to understand the essence of the research. Any other conditions that limit the validity of obtaining informed consent or may affect the volunteer's ability to participate in the study.
- Participation in any other study in the last 90 days;
- Presence of an infection of another organ other than a bladder infection, such as endocarditis, osteomyelitis, abscess, meningitis, pneumonia, etc.
- Symptoms requiring hospitalization (macrohematuria, concomitant diseases that complicate the course of the disease).
- Cystocele of 3-4 degrees.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluorothiazinone, tablets 300 mgpatients will receive Fluorothiazinone, tablets 300 mg at a dose 1200 mg/day (2 tablets twice a day) for 14 days | Drug | Drug: Fluorothiazinone, tablets 300 mg |
| Nitrofurantoin 100 MGComparison arm patients will receive Nitrofurantoin in accordance with the instructions for medical use. | Drug | Comparator: Nitrofurantoin |
Primary outcome
AEs
Time frame: Within 90 days after administration of the drug.
Occurrence of adverse events/reactions.
SAEs
Time frame: Within 90 days after administration of the drug.
Occurrence of serious adverse events/reactions.
Complete resolution or improvement of the signs and symptoms of chronic cystitis
Time frame: 7th, 14th and 28th days after the start of therapy.
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.
Relapse
Time frame: Within 90 days from the start of therapy.
Relapse of chronical bacterial cystitis monitoring.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
N.F. Gamaleya NRCEM, Health Ministry of the Russian Federation contact
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fluorothiazinone, tablets 300 mg and Nitrofurantoin 100 MG in people with P. Aeruginosa and Baumannii, run by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact N.F. Gamaleya NRCEM, Health Ministry of the Russian Federation (+7 (499) 193-30-01, info@gamaleya.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AEs (time frame: Within 90 days after administration of the drug.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.