Clinical Trial to investigate the efficacy and safety of ANGOCIN® Anti-Infekt N against placebo preventing urinary tract infections in catheterized patients

Phase 1

• Conditions: Prophylaxis of catheter-associated chronically inflammatory recurring urinary tract infections in adult patients; MedDRA version: 20.0Level: LLTClassification code 10046544Term: Urinary infectionSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 21.0Level: LLTClassification code 10007810Term: Catheter related infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2016-004842-27-DE
• Lead Sponsor: Repha GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-16
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

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 < 10^5 cfu/mL and LEU < 100/mm^3 or
o Urine culture < 10^5 cfu /mL or
o LEU < 100/mm^3

Subgroup II - Non-Paraplegic Patients
o urine culture < 10^5 cfu/mL and no clinical symptoms or
o no clinical symptoms or
o urine culture < 10^5 cfu/mL
symptoms are i. a. dysuria, flank pain, fever, signs of an autonomous dysreflexia

Patients having signed written informed consent.
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 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

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

Study & Design

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