Safety and Efficacy Study of Ftortiazinon in the Treatment of Patients With Complicated Urinary Tract Infections Caused by P. Aeruginosa

NCT03638830 | Completed Phase 2 DMC

• 1 other identifier: 04-FT-2018
• Study Type: interventional
• Target: 777
• Locations: 1 country
• Sites: 5

Brief Summary

This study is planned to evaluate the safety and efficacy of the drug Ftortiazinon in combination with the drug Maxipime® in comparison with placebo in combination with the drug Maxipime® in the treatment of hospitalized adult patients with complicated urinary tract infections caused by P. aeruginosa.

Conditions

Patients With Complicated Urinary Tract Infections Caused by P. Aeruginosa; Pseudomonas Aeruginosa; Pseudomonas Infections; Urinary Tract Infections

Keywords

Pseudomonas Aeruginosa; antibiotic resistance; factors of pathogenicity of bacteria; the system of secretion of type III pathogenic bacteria; Pseudomonas Infections; Urinary Tract Infections

Outcome Measures

Primary Outcomes (1)

• clinical cure and microbiological eradication

  proportion of patients with overall positive effect

  through the whole study, an average of 90 days

Secondary Outcomes (7)

• proportion of patients with clinical cure response

  through the whole study, an average of 90 days

• proportion of patients with response in the form of microbiological eradication

  through the whole study, an average of 90 days

• microbiological eradication

  day 7

• number of patients with treatment response as clinical cure

  day 7

• Number of Participants With Adverse Events

  through the whole study, an average of 90 days

Study Arms (3)

Group 1

EXPERIMENTAL

Ftortiazinon tablets 300 mg (FSBI "N.F. Gamaleya NRCEM" of the Ministry of Health of the Russian Federation)1/2 dose + placebo+ Maxipime®

Drug: Ftortiazinon (tablets 300 mg) 1/2 dose +placebo+ Maxipim

Group 2

EXPERIMENTAL

Ftortiazinon tablets 300 mg (FSBI "N.F. Gamaleya NRCEM" of the Ministry of Health of the Russian Federation) full dose + Maxipime®

Drug: Ftortiazinon (tablets 300 mg) full dose + Maxipim

Group 3

PLACEBO COMPARATOR

placebo (like full dose) in combination with the drug Maxipime®

Other: placebo+Maxipim

Interventions

Ftortiazinon (tablets 300 mg) 1/2 dose +placebo+ Maxipim DRUG

Ftortiazinon tablets 300 mg (FSBI "N.F. Gamaleya NRCEM" of the Ministry of Health of the Russian Federation)+placebo

Group 1

Ftortiazinon (tablets 300 mg) full dose + Maxipim DRUG

Ftortiazinon tablets 300 mg (FSBI "N.F. Gamaleya NRCEM" of the Ministry of Health of the Russian Federation)

Group 2

placebo+Maxipim OTHER

placebo

Group 3

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. The ability to understand the requirements of the study participants, to give written consent to participate in the study (including the use and transfer of information about the patient's health related to the study) and the implementation of the procedures provided by the Study Protocol.
• \. Availability of the patient's written consent to participate in the study according to the current legislation.
• \. Male or female participants must be ≥18 and ≤80 years of age. 4. It is expected that patient's treatment of complicated UTI will require hospitalization and the use of antibiotic therapy.
• \. Suspected or documented complicated UTI as defined below and subject to the mandatory presence of one or more of the risks associated with the complicated UTI listed below:
• Complicated urinary tract infection (complicated UTI):
• presence of at least 2 of the following signs or symptoms:
• chills, tremors, or body temperature increases associated with fever (body temperature of 38ºC) (fever documented by a medical professional within 24 hours prior to screening);
• nausea or vomiting within 24 hours prior to screening;
• dysuria, frequent urination or urgent need to urinate;
• pain in the lower abdomen;
• acute pain in the side (occurred within 7 days prior to randomization) or pain in the region of the rib-vertebral angle during physical examination.
• leukocyturia in a urine sample (presence of at least one of the following signs):
• positive reaction to leukocyte esterase based on the results of the common urine examination;
• number of leukocytes ≥ 10 cells/mm3 in non-centrifuged urine sample;
• number of leukocytes ≥ 10 cells / per HPF in the urine sediment. 6. At least one of the following associated risks: • periodic bladder catheterization or the presence of a permanent bladder catheter, ureters (ureter stent), kidneys (nephrostoma) (catheters installed more than 24 hours prior to screening should be removed or replaced prior to collection of an urine sample for analysis and sowing, unless removal or replacement is considered unsafe or contraindicated);

You may not qualify if:

• \. Presence of any known or suspected disease, or condition that may distort the assessment effectiveness, including, but not limited to, the following:
• perinephral abscess;
• corticomedullary kidney abscess;
• any history of pelvic or urinary tract injury within 30 days prior to the study;
• polycystic kidney disease;
• chronic vesicoureteral reflux;
• prior or planned kidney transplantation;
• dialysis patients, including those under hemodialysis, peritoneal dialysis or continuous venovenous hemofiltration (CVVH);
• previous or planned cystectomy or surgery on the loop of ileum;
• presence of a known or suspected infection that is caused by fungi (e.g. candiduria) or mycobacteria (e.g. urogenital tuberculosis).
• \. Presence of suspected or confirmed acute bacterial prostatitis, orchitis, epididymitis or chronic bacterial prostatitis determined by anamnesis and/or general medical examination.
• \. Macrogematuria requiring treatment other than administration of the drug under study or removal, or replacement of the urinary catheter.
• \. Surgery on the urinary tract within 7 days before randomization, or surgery on the urinary tract planned during the period of study (except surgical intervention necessary to remove the obstruction or placement of the stent or holding of a nephrostomy until the end of treatment (medical and pedagogical observations).
• \. Renal function in screening evaluated by creatinine clearance as \< 50 ml / min using the Cocroft-Gault formula and serum creatinine values obtained in a local laboratory.
• \. Source of infection diagnosed within 7 days prior to randomization with known extra-renal origin, such as endocarditis, osteomyelitis, abscess, burn urinary tract infection; meningitis or pneumonia.

Sponsors & Collaborators

• Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation: lead
• Acellena Contract Drug Research and Development: collaborator

Study Sites (5)

Road Clinical Hospital of Open Joint Stock Company "Russian Railways

Saint Petersburg, Sankt-Peterburg, Russia

Location

St. Petersburg state budgetary institution of health care " City hospital № 26"

Saint Petersburg, Sankt-Peterburg, Russia

Location

Baltic Medicine

Saint Petersburg, Russia

Location

Scientific and Research Center "Eco-Safety"

Saint Petersburg, Russia

Location

Vsevolozhsk Clinical Interdistrict Hospital

Vsevolozhsk, Russia

Location

Related Links

• The Effect of Cefepime/Fluorothiazinone Compared with Cefepime/Placebo on Clinical Cure and Microbiological Eradication in Patients with Complicated Urinary Tract Infections: A Prospective Randomized Clinical Trial

MeSH Terms

Conditions

Pseudomonas Infections; Urinary Tract Infections

Interventions

Tablets

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Victor Shunkov, MD, PhD

  Road Clinical Hospital of Open Joint Stock Company "Russian Railways

  PRINCIPAL INVESTIGATOR

• Alexander Shvets, MD

  Saint-Petersburg Clinical Hospital of the Russian Academy of Sciences

  PRINCIPAL INVESTIGATOR

• Dmitry Gorelov, MD

  Scientific and Research Center "Eco-Safety"

  PRINCIPAL INVESTIGATOR

• Lyudmila Kulagina, MD

  Republican Clinical Hospital of the Ministry of Health of the Republic of Tatarstan

  PRINCIPAL INVESTIGATOR

• Elena Matevosyan, MD

  Vsevolozhsk Clinical Interdistrict Hospital

  PRINCIPAL INVESTIGATOR

• Maria Mozheyko, MD

  Yaroslavl Regional Clinical Hospital for Military Veterans

  PRINCIPAL INVESTIGATOR

• Lev Sinelnikov, MD

  S.M. Kirov Military Medical Academy

  PRINCIPAL INVESTIGATOR

• Maksim Bushara, MD

  Baltic Medicine

  PRINCIPAL INVESTIGATOR

• Ashot Yesayan, MD

  Saint-Petersburg State Budgetary Healthcare Institution "City Clinical Hospital No. 31"

  PRINCIPAL INVESTIGATOR

• Alexander Mangushlo, MD

  St. Petersburg state budgetary institution of health care " City hospital № 26"

  PRINCIPAL INVESTIGATOR

• Andrey Gorelov, MD

  St. Petersburg state budgetary institution of health care " city Pokrovskaya hospital"

  PRINCIPAL INVESTIGATOR

• Grigory Arutunov, MD

  Pirogov Russian National Research Medical University

  PRINCIPAL INVESTIGATOR

• Ivan Palagin, MD

  Smolensk regional clinical hospital

  PRINCIPAL INVESTIGATOR

• Igor Shormanov, MD

  State Autonomous healthcare institution of Yaroslavl region Clinical hospital № 9

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: In order to minimize subjectivity, block randomization will be carried out in treatment groups without stratification in the center. Randomization will be carried out by the method of envelopes. To minimize the subjectivity of clinical study of the efficacy and safety of the drug "Ftortiazinon" will be conducted with the use of a placebo, which will not differ in appearance, shape, color, and will fully simulate the investigated product. To distribute the drug to patients, taking into account the need to observe the blinding, a special authorized person (an unblided research pharmacist) will be appointed in each medical organization.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized, blind, placebo-controlled study

Study Record Dates

• First Submitted: August 7, 2018
• First Posted: August 20, 2018
• Study Start: October 17, 2018
• Primary Completion: November 23, 2022
• Study Completion: November 23, 2022
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

RU (5)