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

Urinary Tract Infections Clinical Trial

Official title: Randomized, Blind, Placebo-controlled Study to Evaluate Safety and Efficacy of Ftortiazinon in Combination With Maxipime®, in Comparison With Placebo in Combination With Maxipime®, in the Treatment of Patients With Complicated Urinary Tract Infections Caused by P. Aeruginosa

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

The study is divided into 2 phases.

The course of treatment will be single (course of therapy with the drug/placebo under study) for a group consisting of three cohorts, and also single for a group of phase 2 participants (770 patients in total) consisting of two cohorts groups. The recruitment of patients to the second phase will commence after the evaluation of the data on safety and efficiency by the expert commission within the framework of reviewing the amendment to the current Study Protocol. At the second phase, it is proposed to study the optimal dosage chosen based on the results of the first (search phase) study.

This study is aimed at evaluating the efficacy, safety and tolerability of the drug Ftortiazinon tablets 300 mg (FSBI "N.F. Gamaleya NRCEM" of the Ministry of Health of the Russian Federation) in combination with the drug Maxipime®, a powder for the preparation of a solution for intravenous and intramuscular administration of 1.0 g (Bristol-Myers Squibb, USA), in comparison with placebo in combination with the drug Maxipime®, a powder for the preparation of a solution for intravenous and intramuscular administration of 1.0 g (Bristol-Myers Squibb, USA), in the treatment of patients with complicated urinary tract infections (complicated UTIs) caused by P. aeruginosa.

FIRST PHASE (search phase) At this phase, the patients will take the drug Ftortiazinon tablets 300 mg (FSBI "N.F. Gamaleya NRCEM" of the Ministry of Health of the Russian Federation) in combination with the drug Maxipime®, a powder for the preparation of a solution for intravenous and intramuscular administration of 1.0 g (Bristol-Myers Squibb, USA).

According to the results of the screening of patients who have signed the Informed Consent Form, the patients are recruited in three groups with different doses of the drug. The total number of patients who received the drug or placebo will be at least 240 people according to the following scheme:

Group 1 (80 patients) - Ftortiazinon tablets 300 mg (FSBI "N.F. Gamaleya NRCEM" of the Ministry of Health of the Russian Federation) plus placebo. The drug is administered according to the following scheme on the first day: the first administration of Ftortiazinon 300 mg (1 tablet) plus placebo (1 tablet) 30 minutes after eating with lukewarm water, the second administration - 1 tablet (300 mg) after 12 hours, then within 6 days the drug is prescribed 1 tablet once a day plus 1 tablet of placebo (interval: 12 hours) 30 minutes after eating.

Group 2 (80 patients) - Ftortiazinon tablets 300 mg (FSBI "N.F. Gamaleya NRCEM" of the Ministry of Health of the Russian Federation). The drug is administered according to the following scheme on the first day: the first administration of 600 mg (2 tablets) 30 minutes after eating with lukewarm water, the second administration - 1 tablet (300 mg) after 12 hours, then within 6 days the drug is prescribed 1 tablet twice a day at intervals of 12 hours.

Group 3 (80 patients) - placebo in combination with the drug Maxipime®, a powder for the preparation of a solution for intravenous and intramuscular administration of 1.0 g (Bristol-Myers Squibb, USA). The drug is administered according to the following scheme on the first day: the first administration of 2 tablets 30 minutes after eating with lukewarm water, the second administration - 1 tablet after 12 hours, then within 6 days the drug is prescribed 1 tablet twice a day at intervals of 12 hours 30 minutes after eating.

For all groups: Maxipime®, a powder for the preparation of a solution for intravenous and intramuscular administration of 1.0 g (Bristol-Myers Squibb, USA). The drug is administered according to the following scheme: the drug with a dosage of 1.0 g is dissolved in 2.4 ml of sterile water for injection or 0.9% sodium chloride solution, or 0.5-1% lidocaine hydrochloride solution; then injected deep into the muscle, into the upper outer quadrant of the buttocks after pre-aspiration every 12 hours for 7 days*.

SECOND PHASE (confirmation phase) The transition to this phase of the study to assess efficacy and safety of the drug Ftortiazinon will be carried out after selecting the optimal dosage according to the results of the first (confirmation phase) study.

This transition will be carried out by making a corresponding amendment to the Study Protocol with the provision of data confirming the efficacy and safety of the selected therapeutic scheme.

The assessment will be conducted according to the results of the 21-day surveillance for patients after completion of therapy with a drug/placebo.

Group 1 patients will take the drug Ftortiazinon tablets 300 mg (FSBI "N.F. Gamaleya NRCEM" of the Ministry of Health of the Russian Federation) in combination with the drug Maxipime®, a powder for the preparation of a solution for intravenous and intramuscular administration of 1.0 g (Bristol-Myers Squibb, USA) in accordance with the dosage regimen selected at the first phase.

Maxipime® is a powder for the preparation of a solution for intravenous and intramuscular administration of 1.0 g (Bristol-Myers Squibb, USA). It is administered according to the following scheme: the drug with a dosage of 1.0 g is dissolved in 2.4 ml of sterile water for injection or 0.9% sodium chloride solution, or 0.5-1% lidocaine hydrochloride solution; then injected deep into the muscle, into the upper outer quadrant of the buttocks after pre-aspiration every 12 hours for 7 days.

Group 2 patients will take placebo in combination with the drug Maxipime®, a powder for the preparation of a solution for intravenous and intramuscular administration of 1.0 g (Bristol-Myers Squibb, USA). Placebo is taken according to the scheme corresponding to those chosen at the first phase.

Maxipime® is a powder for the preparation of a solution for intravenous and intramuscular administration of 1.0 g (Bristol-Myers Squibb, USA). It is administered according to the following scheme: the drug with a dosage of 1.0 g is dissolved in 2.4 ml of sterile water for injection or 0.9% sodium chloride solution, or 0.5-1% lidocaine hydrochloride solution; then injected deep into the muscle, into the upper outer quadrant of the buttocks after pre-aspiration every 12 hours for 7 days.

Administration/injection of drugs Ftortiazinon/placebo and Maxipime® should be carried out simultaneously, preferably in one and the same time every day. Let the administration of Ftortiazinon/placebo will be for 30 min after administration of the drug Maxipime®.

The duration of therapy with Maxipime® will be 7 calendar days; however, if the patient has no positive dynamics in the evaluation of clinical symptoms of complicated UTIs, there is an increase in uropathogen in the urine culture obtained on Visit 2, and the duration of therapy can be increased to a total of 14 calendar days. ;

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Patients With Complicated Urinary Tract Infections Caused by P. Aeruginosa
• Pseudomonas Aeruginosa
• Pseudomonas Infections
• Urinary Tract Infections

• NCT number: NCT03638830
• Study type: Interventional
• Source: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
• Contact: Nailya Zigangirova, PhD
• Phone: 193 30 60
• Email: zigangirova@mail.ru
• Status: Recruiting
• Phase: Phase 2
• Start date: October 17, 2018
• Completion date: January 31, 2022