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

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

Interventions

DRUG

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

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

DRUG

Ftortiazinon (tablets 300 mg) full dose + Maxipim

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

OTHER

placebo+Maxipim

placebo

Sponsors & Collaborators

• Acellena Contract Drug Research and Development

  collaborator OTHER

• Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

  lead OTHER

Principal Investigators

• Victor Shunkov, MD, PhD · Road Clinical Hospital of Open Joint Stock Company "Russian Railways

• Alexander Shvets, MD · Saint-Petersburg Clinical Hospital of the Russian Academy of Sciences

• Dmitry Gorelov, MD · Scientific and Research Center "Eco-Safety"

• Lyudmila Kulagina, MD · Republican Clinical Hospital of the Ministry of Health of the Republic of Tatarstan

• Elena Matevosyan, MD · Vsevolozhsk Clinical Interdistrict Hospital

• Maria Mozheyko, MD · Yaroslavl Regional Clinical Hospital for Military Veterans

• Lev Sinelnikov, MD · S.M. Kirov Military Medical Academy

• Maksim Bushara, MD · Baltic Medicine

• Ashot Yesayan, MD · Saint-Petersburg State Budgetary Healthcare Institution "City Clinical Hospital No. 31"

• Alexander Mangushlo, MD · St. Petersburg state budgetary institution of health care " City hospital № 26"

• Andrey Gorelov, MD · St. Petersburg state budgetary institution of health care " city Pokrovskaya hospital"

• Grigory Arutunov, MD · Pirogov Russian National Research Medical University

• Ivan Palagin, MD · Smolensk regional clinical hospital

• Igor Shormanov, MD · State Autonomous healthcare institution of Yaroslavl region Clinical hospital № 9

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-10-17

Primary Completion

2022-11-23

Completion

2022-11-23

Countries

• Russia

Study Locations