ot available

• Conditions: MedDRA version: 14.1Level: HLTClassification code 10046577Term: Urinary tract infectionsSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]; Treatment of urinary tract infection; MedDRA version: 14.1Level: PTClassification code 10046571Term: Urinary tract infectionSystem Organ Class: 10021881 - Infections and infestations

• Registration Number: EUCTR2011-004594-82-BG
• Lead Sponsor: Schur Pharmazeutika GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10-20
• Last Update Posted: 11 November 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

[1] 18 years and older
[2] Patients with long term indwelling intravesical catheter (urethral or suprapubic) in place for at least 28 days
[3] Patients with significant bacteriuria defined as =10^5 CFU/ml
determined bymeans of Uricult® Trio test (CLED medium)
[4] Patients with ability to follow study instructions and likely to attend
and complete all required visits
[5] Written informed consent of the patient
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 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 400

Exclusion Criteria

1. Hypersensitivity to the active substances or to any of the excipients of
the study drug, or to any related drug
2. Severe urinary tract infection (e.g. with fever of >39°C) which
requires systemic antibacterial treatment
3. Urinary tract infection other than cystitis: pyelonephritis, prostatitis
4. Urinary tract infection caused by or associated with nephrolithiasis
5. Cystitis caused by or associated with urolithiasis of the bladder
6. Exchange of the intravesical catheter during the trial
7. Patients with chronic kidney disease of stage 3 or higher: glomerular
filtration rate of less than 60 ml/min or serum creatinine above 150 µmol/l
8. Treatment with systemic antibiotics within the last 14 days before
screening or during the trial
9. Intravesical administration of antibacterial medication (including disinfectants like povidone iodine or similar) within the last 4 days before screening or during the trial
10. Administration into the catheter of antibacterial medication
(including disinfectants like povidone iodine or similar) during the trial
11. Indwelling intravesical catheter with an antibacterial internal coating
12. Inability to contain the trial medication in the urinary bladder for at
least 60 minutes on more than 2 occasions
13. Lesions of the epithelium of the urinary bladder
14. Hearing or vestibular impairment
15. Myasthenia gravis
16. Concomitant intake/administration of muscle relaxing agents
17. Pregnancy or lactation
18. Simultaneous participation in another clinical study or participation in any clinical study involving an investigational drug within 3 months prior to start of the present study
19. Severe physical or mental concomitant diseases that might ham-per
the realization of the trial according to protocol
20. Legal incapacity and/or other circumstances rendering the patient
unable to understand the nature, scope and possible consequences of the study
21. Unreliability or lack of cooperation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified