Treatment of urinary tract infection MedDRA version: 14.1 Level: PT Classification code 10046571 Term: Urinary tract infection System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1 Level: HLT Classification code 10046577 Term: Urinary tract infections System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: Neomycin sulfate solution
Product Code: not applicable
Pharmaceutical Form: Intravesical solution
INN or Proposed INN: NEOMYCIN SULFATE
CAS Number: 1405-10-3
Current Sponsor code: not ap
Sponsors
Schur Pharmazeutika GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of intravesical neomycin sulfate 15 mg/ml (Neomycin sulfate solution) as compared to placebo for the treatment of acute urinary tract infection in patients with permanent intravesical catheter based on the proportion of patients with a result of <10^5 CFU/ml in urine determined by means of Uricult® Trio test (CLED medium) either 24 or 48 hours after the end of 5 days of treatment at the earliest time point at which no measurable concentration of neomycin is registered in urine.;Secondary Objective: - To evaluate the proportion of patients with a result of <10^3 CFU/ml determined in urine between 24 and 48 hours after the end of treatment by means of Uricult® Trio test (CLED medium), - To evaluate leukocytes in urine between 24 and 48 hours after the end of treatment determined by means of a dipstick test, - To evaluate the proportion of patients in which resistance to neomycin develops in the course of treatment, defined as at least one type of microorganism isolated from the CLED medium of the Uricult® Trio being sensitive before treatment and becoming resistant after treatment, - To evaluate the ratings of suprapubic tenderness and change in the character of the urine by the investigator, - To evaluate the ratings of overall efficacy by the investigator. - To evaluate the safety of the test product;Primary end point(s): Proportion of patients with a result of <10^5 CFU/ml in urine determined by means of Uricult® Trio test (CLED medium) either 24 or 48 hours after the end of 5 days of treatment at the earliest time point at which no measurable concentration of neomycin is registered in urine.;Timepoint(s) of evaluation of this end point: After 5 days of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): a) proportion of patients with a result of <10^3 CFU/ml in urine determined by means of Uricult® Trio test (CLED medium) either 24 or 48 hours after the end of 5 days of treatment at the earliest time point at which no measurable concentration of neomycin is registered in urine b) proportion of patients positive for leukocytes in urine determined daily for the duration of the trial by means of a dipstick test, c) proportion of patients in which resistance to neomycin develops in the course of treatment, defined as at least one type of microorganism isolated from the CLED medium of the Uricult® Trio being sensitive before treatment and becoming resistant after treatment, d) ratings of suprapubic tenderness and character of the urine by the investigator, e) ratings of overall efficacy by the investigator;Timepoint(s) of evaluation of this end point: After 5 days of treatment | — |
Countries
Bulgaria
Contacts
Public ContactP. Venezia
Schur Pharmazeutika GmbH & Co. KG
Outcome results
None listed