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Clinical Trials/EUCTR2016-004842-27-DE
EUCTR2016-004842-27-DE
Active, not recruiting
Phase 1

Clinical Trial to investigate the efficacy and safety of ANGOCIN® Anti-Infekt N versus placebo in the prophylaxis of catheter associated urinary tract infections - CAUTI

Repha GmbH0 sites100 target enrollmentMarch 16, 2017
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ConditionsProphylaxis of catheter-associated chronically inflammatory recurring urinary tract infections in adult patientsMedDRA version: 20.0Level: LLTClassification code 10046544Term: Urinary infectionSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 21.0Level: LLTClassification code 10007810Term: Catheter related infectionSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
DrugsAngocin Anti-Infekt N

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Prophylaxis of catheter-associated chronically inflammatory recurring urinary tract infections in adult patients
Sponsor
Repha GmbH
Enrollment
100
Status
Active, not recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 16, 2017
End Date
TBD
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Repha GmbH

Eligibility 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 \< 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

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)

Outcomes

Primary Outcomes

Not specified

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