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
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
To evaluate the therapy effectiveness:
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 →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.
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.
Exclusion Criteria:
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.
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.
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.
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.
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.
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Comparison arm patients will receive Nitrofurantoin in accordance with the instructions for medical use.
Drug: Nitrofurantoin 100 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.
AEs
Occurrence of adverse events/reactions.
Time frame: Within 90 days after administration of the drug.
SAEs
Occurrence of serious adverse events/reactions.
Time frame: 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.
Time frame: 7th, 14th and 28th days after the start of therapy.
Relapse
Relapse of chronical bacterial cystitis monitoring.
Time frame: Within 90 days from the start of therapy.
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
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.
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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Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation