Safety and Efficacy Study of Ftortiazinon in the Treatment of Patients With Complicated Urinary T… (NCT03638830) | Clinical Trial Compass
CompletedPhase 2
Safety and Efficacy Study of Ftortiazinon in the Treatment of Patients With Complicated Urinary Tract Infections Caused by P. Aeruginosa
Russia777 participantsStarted 2018-10-17
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
* 1\. 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.
2\. Availability of the patient's written consent to participate in the study according to the current legislation.
3\. 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.
5\. 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):
* positiv…
What they're measuring
1
clinical cure and microbiological eradication
Timeframe: through the whole study, an average of 90 days
Trial details
NCT IDNCT03638830
SponsorGamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation