This study aims to find out how effective and save Angocin Anti-Infekt N is in treatment of acute uncomplicated cystitis in contrast to standard antibiotics.

Active, not recruiting

Conditions: Treatment of acute uncomplicated cystitis
MedDRA version: 14.1Level: PTClassification code 10011781Term: CystitisSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Registration Number: EUCTR2010-022096-54-DE

Lead Sponsor: Repha GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Patients of both sexes aged between 18 and 70 years, with an acute uncomplicated cystitis (diagnosed by the investigator), signed informed consent form, leucocytes in urine positive at visit 1, bacteriurie (>10^5 cfu/ml) in urine at visit 1
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 712
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

Exclusion Criteria

- signs of a complicated urinary tract infection
- acute infection beneath cystitis
- known hypersensitivity to any of the components of the study medicine
- irritable bladder
- pyelonephritis, urosepsis
- subjects with a disease or in any situation that exposed the opinion of the investigator the subject is a significant risk of prejudice the study results or influence them significantly
- abnormal laboratory values
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Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Number of subjects with reduced number of bacteria causing the urinary tract infection from over or equal 10^5 at visit 1 to under or equal 10^3 after the treatment with study medication at visit 3.<br><br>;Secondary Objective: efficacy, safety and compatibility;Primary end point(s): The number of subjects with < or = 10^3 cfu/ml in urine at visit 3.;Timepoint(s) of evaluation of this end point: Visit 3

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Change of symptom scores from Visit 1 to Visit 3<br>- Duration to onset of symptom freedom <br>- Assessing the effectiveness of the doctor to visit 3<br>- Relapse frequency / or new infections between visit 3 and visit 4<br>- Evaluation of the course of the disease by the doctor (visit 2 and 3)<br>- Appearance AE/SAE<br>- control of blood values (safety)<br>- vital signs<br>- assessment of tolerance by the patient<br>- Laboratory examination of urine by urine sediment analysis<br>- Number of resistant patients<br>- Patient compliance <br>- Patient satisfaction<br>- number of patients with recurrent urinary tract infection<br>- results of inhibitor test and pathogen identification;Timepoint(s) of evaluation of this end point: mostly visit 3 or visit 4, see also E.5.2