Prophylaxis of catheter-associated chronically inflammatory recurring urinary tract infections in adult patients MedDRA version: 20.0 Level: LLT Classification code 10046544 Term: Urinary infection System Organ Class: 10021881 - Infections and infestations MedDRA version: 21.0 Level: LLT Classification code 10007810 Term: Catheter related infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Angocin Anti-Infekt N
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Horseradish root powder
Other descriptive name: HORSERADISH, Meerrettichwurzelpulver
Concentration unit:
Sponsors
Repha GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients of both sexes = 18 years of age who want to participate in a prophylaxis study after treatment of a catheter-associated urinary tract infection (CAUTI) and who are currently not relevant for Treatment: Subgroup I - Paraplegic patients o Urine culture =65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: - Progression of infection proximal of urinary bladder or spreading of pathogens (urosepsis) - Signs of restricted renal function - Known Glomerulonephritis / interstitial nephritis or proteinuria - Acute infections besides infections of the lower urinary tract during Screening Phase (visit 1 to visit 2) - Acute gastric ulcer or acute ulcer of duodenum - Abnormal laboratory results (clinically significant, i. e. more than three-times different compared to upper and lower laboratory standard-thresholds, except inflammatory parameters CRP (blood), leukocytes (urine), erythrocytes (urine) - patients for whom permanent antibiotic therapy is required (permanent means > 1 week) - patients with catheter systems, in which the catheter itself is not in contact with any outer-body region (e. g. double J ureteral stent) - Patients with risk factors for a more severe Progression: inadequately controlled Diabetes mellitus, diseases of the fascia, polycistic nephropathy - Abnormal INR value in patients undergoing anticoagulation therapy or anticoagulation prophylaxis with vitamin K antagonists (clinically significant, i.e. depending on the indication or signinficant at the investigator´s discretion) - Known hypersensitivity to nasturtium, horseradish root or any excipient of the study medication - immune supressed patients (patients with organ transplantation within the previous 3 years, patients with HIV, etc.) - Patients with malignant diseases of the urinary tract (kidney, Ureter, bladder, genital) within the previous 5 years - Patients with a medical condition or a situation which, in the opinion of the investigator, poses a significant risk to the patient or which could impair or considerably influence the results of the Trial - Pregnant or breast-feeding women or women planning to become pregnant; women capable of bearing children and not applying a highly effective contraception (Pearl Index <1) - Simultaneous participation in another trial or participation in a clinical trial within the last 30 days before inclusion into this Trial - Known abuse of medicinal products, alcohol or other drugs - Serious diseases of the Psyche - Persons which are institutionalised by regulatory or judicial decree
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Incidence for the occurence of the first recurrence of a catheter-associated urinary tract infection during the course of prophylaxis (day 0 to 28) A recurrence / the catheter-associated urinary tract infection is defined as follows: Subgroup I - Paraplegic Patients - Bakteriuria = 10^5 cfu/mL and leukocyturia = 100/mm^3 (S2k Leitlinie Neuro-urologische Versorgung querschnittgelähmter Patienten, 2016) Subgroup II - Non-Paraplegic Patients - Bakteriuria = 10^5 KBE/mL and clinical symptoms (min. 1) with / without leukocyturia = 100/mm^3; Symptoms i. a. dysuria, flank pain, fever, signs of autonomous dysreflexia (S2k Leitlinie Management und Durchführung des Intermittierenden Kathete-rismus (IK) bei Neurogenen Blasenfunktionsstörungen, 2016);Secondary Objective: -Spectrum of ident. main uropathogen(s) -Comparison of rates of first recurrences during prophylaxis between groups(D0-28) -Time until first recurrence during the opt. follow-up(D29-84) -Comparison of the rates of recurrences during the opt. follow-up(D29-84) -assessment of efficacy by investigator(V3-6 or Exit,VAP,F1/F2) -Type, frequency and severity of reported adverse events and unexpected adverse drug reaction -Distri. of laboratory parameters of blood samples during the relapse prophylaxis:Haematology and clin.chemistry -Distri. of coagulation parameter(INR) in patients undergoing anticoagulation therapy or prophylaxis with vitamin K antagonists(V1-6,VAP,EXIT) -Distri. of vital signs during the relapse prophylaxis: Pulse,blood pressure,body temperature -Assessment of tolerance of study medication by investigator and patient(V3-6,Exit,VAP,F1/F2) -Compliance(amount of consumed study medication) -Patient satisfaction -Results of pathogen identification after recurrence;Primary end point(s): Incidence for the occurence of the first recurrence of a catheter-associated urinary tract infection during the course of prophylaxis (day 0 to 28) A recurrence / the catheter-associated urinary trac | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary end points will be part of the explorative data analyses set. Therefore secondary end points are not in the scope of statistical analysis according to Lehmacher and Wassmer.;Timepoint(s) of evaluation of this end point: Secondary end points will be part of the explorative data analyses set. Therefore secondary end points are not in the scope of statistical analysis according to Lehmacher and Wassmer. | — |
Countries
Germany
Contacts
Public ContactClinical Research
Mediconomics GmbH
Outcome results
None listed