CINEOLE for MRSA colonisation | Methicillin-resistant Staphylococcus aureus nasal carriage

Inclusion criteria

• {"criterion_text":"- Willing and able to give informed consent to participate in the study."}
• {"criterion_text":"- Patients aged between 18 and 70 years with positive nasal swabs for MRSA strains."}
• {"criterion_text":"- Presence of MRSA strains in nasal swab cultures taken at the first initial screening visit (V0)."}
• {"criterion_text":"- Patients willing to avoid pregnancy or paternity based on the following criteria: a) a woman who is incapable of having children (after surgery to remove the uterus or bilateral ovaries, or after menopause, defined as a period of at least at least 12 months since the last menstrual period) is exempt from pregnancy tests, b) a woman capable of having children with a negative pregnancy test result prior to day 1 dosing and who agrees to take cyclic pregnancy tests according to the study protocol and to take appropriate contraceptives up to one month after the end of treatment, c) a man who agrees to take appropriate precautions to avoid paternity (with at least 99% certainty) and/or to refrain from donating sperm from the screening visit until 30 days after treatment."}

Exclusion criteria

• {"criterion_text":"- Pregnant or breastfeeding women."}
• {"criterion_text":"- An illness or medical, physical or mental condition of the subject that, in the opinion of the investigator, would interfere with full participation in the study (for example administration of the study drug or attendance at required study visits), or pose a significant risk to the subject or interfere with the interpretation of data from the study."}
• {"criterion_text":"- Use of the investigational medicinal product within 30 days prior to inclusion in the study."}
• {"criterion_text":"- Hypersensitivity or allergy to mupirocin, 1,8-cineole, and/or any of the ingredients of the investigational medicinal product."}
• {"criterion_text":"- Contraindication to endoscopic examination of the nasal cavity."}
• {"criterion_text":"- Use of other intranasal preparations."}
• {"criterion_text":"- Patients requiring treatment with antibiotic or systemic corticosteroids."}
• {"criterion_text":"- Past surgery in the nasal cavity or paranasal sinuses within the last 6 months."}
• {"criterion_text":"- Presence of cystic fibrosis or ciliary dyskinesia."}
• {"criterion_text":"- Presence of active cancer."}
• {"criterion_text":"- Immunodeficiency."}
• {"criterion_text":"- Past or current participation in another clinical trial within the past 3 months."}

Primary endpoints

• {"endpoint_text":"- the efficacy of 18C in monotherapy and combination therapy in patients with chronic active monoinfection/carriage of Staphylococcus aureus in the nasal cavity, as determined by microbiological analysis (both qualitative and quantitative) immediately after 7 days of therapy.","definition_or_measurement_approach":"Evaluation will be carried out by microbiological examination (nasal cavity culture) immediately after 7 days of therapy."}

Secondary endpoints

• {"endpoint_text":"- decrease in the prevalence of MRSA Staphylococcus aureus carriage (based on the results of the culture)","definition_or_measurement_approach":"Based on culture results (prevalence change)."}
• {"endpoint_text":"- decrease in the number of bacteria in nasal swabs (based on the results of the quantitative test)","definition_or_measurement_approach":"Quantitative microbiological test of bacterial counts in nasal swabs."}
• {"endpoint_text":"- clinical improvement (according to the Lund-Kennedy endoscopic assessment scale, VAS pain severity score)","definition_or_measurement_approach":"Clinical assessment using Lund-Kennedy endoscopic scale and VAS pain severity score."}
• {"endpoint_text":"- ability of applied antimicrobials to eradicate MRSA biofilm in the controlled in vitro study","definition_or_measurement_approach":"In vitro controlled study assessing eradication of MRSA biofilm by applied antimicrobials."}
• {"endpoint_text":"- improvement in quality of life (assessed by the SNOT-22 - Sino-nasal Outcome Test questionnaire)","definition_or_measurement_approach":"Quality of life measured by SNOT-22 questionnaire."}
• {"endpoint_text":"- evaluation of the durability of the therapeutic effect (based on the results of smears of microbiological examination 7, 14, 28 and 35 days after the end of treatment)","definition_or_measurement_approach":"Microbiological smear/culture results at 7, 14, 28 and 35 days post-treatment to assess durability."}
• {"endpoint_text":"- the level of 1,8- cineole concentration in the tested samples (in exhaled air, mucous secretions, saliva measured by High- Speed GS-MS method)","definition_or_measurement_approach":"Measurement of 1,8-cineole concentration in exhaled air, mucous secretions, saliva using High-Speed GS-MS."}

Poland

Earliest CTIS Part Ii Submission Date

19-03-2026

Latest Decision Or Authorization Date

07-04-2026

Processing Time Days

19

Number Of Sites

1

Number Of Participants

300

Primary sponsor

Full Name

Wroclaw Medical University

Organisation Type

Educational Institution

Country Of Registered Address

Poland