MRSA colonisation MedDRA version: 20.0 Level: PT Classification code 10004017 Term: Bacterial disease carrier System Organ Class: 10021881 - Infections and infestations MedDRA version: 20.0 Level: LLT Classification code 10068296 Term: MRSA colonisation 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: Meerrettichwurzelpulver
Concentration unit: mg milligram(
Sponsors
Repha GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients with MRSA colonisation of the nasal vestibule or concurrent MRSA-colonisation of nasal vestibule and throat - Male and female patients aged = 18 years - 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 90 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: - Patients with additional MRSA-positive localizations except nasal vestibule and throat (armpits, groin or perineum) - Current MRSA-infection - signs or symptoms of a beginning bacterial or viral infection in combination with fever (> 38.5°C) - Patient with urgent incation for sanitation (e.g. planned surgery, immunsuppressiv status, persons at risk in home Environment, caMRSA-colonisation/infection) - Patients with penetrating foreign objects (e.g. tracheostoma, catheter, PEG tube, shunts, etc.) - Pateints with sanitation-inhibiting factors - Treatment with antibiotics 7 days prior and during study participation - Intensive care during study participation - Chronic need for care (level 1 at least) - Patients with impaired phagocyte function like diabetic persons or patients requiring dialysis - Acute nephritis - Patients with acute gastric and/or intestinal ulcers - Immuno-compromised patients - Persons dependent from the sponsor or from a contract organization participating in the conduct of the clinical trial - Patients with confirmed active COVID-19 disease or SARS-CoV-2 infection - Signs or symptoms of COVID-19 disease or SARS-CoV-2 infection at the discretion of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of efficacy, safety and tolerability of Angocin Anti-Infekt N administered for MRSA eradication;Secondary Objective: Not applicable;Primary end point(s): Ratio of successfully sanitised patients within the test group and the placebo group;Timepoint(s) of evaluation of this end point: After completion of sanitation (i.e. after 8-week medication intake at maximum and control of sanitation) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy - Duration of sanitation - Investigator's assessment of efficacy Safety and tolerability - Type, frequency and severity of reported adverse Events - Laboratory findings of blood samples: Haematology and clinical chemistry - Vital signs: Heart rate, blood pressure, body temperature - Investigator's and patient's assessment of tolerability;Timepoint(s) of evaluation of this end point: After completion of sanitation (i.e. after 8-week medication intake at maximum and control of sanitation) | — |
Countries
Germany
Contacts
Public ContactClinical Research Organisation
Mediconomics GmbH
Outcome results
None listed