Clinical trial NCT02711943: Non Interventional Study of Levofloxacin in Chronic Prostatitis
Official title: Non-interventional (Observational) Study of the Administration of Levolet® R, Film-coated Tablets (Dr. Reddy's Laboratories Ltd., India) in Adults With Chronic Prostatitis in Routine Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Prostatitis
Lead sponsor: Dr. Reddy's Laboratories Limited
Sponsor class: INDUSTRY
First posted: 2016-03-17
Enrollment: 500
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic prostatitis, age 18-60 years

Brief summary: Chronic prostatitis is a common disease in men with the following typical symptoms decreasing the ability to work and quality of life: pain, urination disorders, copulatory dysfunction.

Following study is conducted to study Levofloxacin in chronic prostatitis.

Detailed description: Chronic prostatitis is a common disease in men with the following typical symptoms decreasing the ability to work and quality of life: pain, urination disorders, copulatory dysfunction. Professional societies recommend diagnosing and treating patients with chronic prostatitis on the basis of determination of belonging to classification categories proposed by the National Institute of Diabetes and Digestive and Kidney Diseases and the National Institutes of Health in the USA .

According to the recommendations of European Association of Urologists, in chronic bacterial inflammation of the prostate and in nonbacterial (inflammatory syndrome of chronic pelvis pain), the performance of antibacterial therapy during four - six weeks is efficient. The first-line drugs are fluoroquinolones (ciprofloxacin and levofloxacin) as along with good tolerance they easily penetrate into the zones of the prostate inflammation and are highly efficient in respect of prostatitis pathogens . Although the treatment with levofloxacin promotes more evident decrease in clinical symptoms and demonstrates better parameters of eradication of pathogen in comparison with ciprofloxacin administration, it is used less common, possibly due to insufficient awareness of physicians of its high efficacy in chronic prostatitis .

Eligibility criteria: Inclusion Criteria:

* male patients aged from 18 to 60 years, inclusive, with a diagnosis of the chronic prostatitis, which appointed the drug Levolet® P as a causal treatment.
* Demonstrated sensitivity to levofloxacin abjection of chronic bacterial prostatitis.
* The presence of a written informed consent to participate in research

Exclusion Criteria:

* participation in another clinical study during the period of this study.

Primary outcomes:
measure: Percentage of patients with response as per IMPSS scale
timeFrame: 28 days
Secondary outcomes:
measure: Percentage of patients response as per IMOS
timeFrame: 28 days
Other outcomes:
Locations:
Study officials:
affiliation: Acad. I.P. Pavlov First Saint-Petersburg State Medical University
name: IGOR A KORNEYEV
role: PRINCIPAL_INVESTIGATOR
References: