Efficacy of 1,8-cineole versus mupirocin for the treatment of nasal methicillin-resistant Staphylococcus aureus carriage: A randomized open-label trial
- Trial ID
- 2025-521569-29-00
- Protocol
- 2024/ABM/01/00042
- Sponsor
- Wroclaw Medical University
Trial statistics
Diseases & Conditions
Objectives
The primary objective is to evaluate the efficacy of 1,8-cineole in treating methicillin-resistant Staphylococcus aureus (MRSA) nasal carriage, as determined by nasal cavity culture seven days post-therapy. This assessment is critical for establishing the therapeutic effectiveness of the oral compound compared to mupirocin. Secondary objectives include:
- The evaluation of 1,8-cineole effectiveness in preventing postnasal carriage of MRSA, assessed through nasal cavity cultures at 7, 14, 21, and 35 days following the conclusion of treatment.
- The pharmacokinetic evaluation of orally administered 1,8-cineole concentrations in exhaled air, mucous secretions, and saliva using High-Speed GS-MS.
Participants
The sponsor did not provide information regarding the total number of participants. The study population consists of patients, including both males and females, diagnosed with methicillin-resistant Staphylococcus aureus (MRSA) nasal colonization or chronic active Staphylococcus aureus mono-infection. Eligible participants are aged between 18 and 70 years and must present with positive nasal swabs for MRSA strains during the initial screening. Specific requirements include the ability to provide informed consent and adherence to strict contraception or pregnancy avoidance protocols for both men and women throughout the study period. The population is categorized as including vulnerable individuals.
Plans and Procedures
This randomized, open-label clinical trial is designed to evaluate the efficacy of 1,8-cineole compared to mupirocin in the treatment of chronic rhinitis caused by methicillin-resistant Staphylococcus aureus carriage in the nasal cavity. The study begins with a screening visit to identify eligible participants, defined as individuals aged 18 to 70 years with positive nasal swabs for MRSA. Following screening, participants receive either the test substance or the comparator. The primary endpoint is determined via microbiological examination of nasal cavity cultures immediately after 7 days of therapy. Secondary objectives include assessing the decrease in bacterial carriage, reduction in bacterial load through quantitative tests, and clinical improvement using the Lund-Kennedy endoscopic assessment scale and VAS pain severity score. Additional evaluations involve the SNOT-22 questionnaire to measure quality of life and the assessment of therapeutic durability through microbiological smears at 7, 14, 28, and 35 days post-treatment. The investigation also monitors 1,8-cineole concentrations in exhaled air, mucous secretions, and saliva using the High-Speed GS-MS method.
Treatment
The experimental treatment consists of cineole, administered as 600 mg via oral use. This substance is evaluated for its efficacy in managing chronic rhinitis associated with methicillin-resistant Staphylococcus aureus colonization.
The comparator treatment involves mupirocin, which is administered via intranasal use at a dose of 2 units. This medication is utilized to compare the effectiveness of the test substance against established therapeutic standards for nasal cavity infections.
Efficacy
The efficacy of 1,8-cineole will be assessed through microbiological analysis, including both qualitative and quantitative methods, performed via nasal cavity culture immediately after 7 days of therapy. The primary endpoint is the determination of effectiveness in patients with chronic rhinitis caused by methicillin-resistant Staphylococcus aureus (MRSA) carriage or mono-infection. Secondary endpoints include the decrease in MRSA prevalence and the reduction in the number of bacteria in nasal swabs.
Clinical efficacy will be evaluated using the Lund-Kennedy endoscopic assessment scale and the Visual Analogue Scale (VAS) for pain severity. Improvement in quality of life will be measured using the SNOT-22 (Sino-nasal Outcome Test) questionnaire. The durability of the therapeutic effect will be monitored through microbiological examination of smears at 7, 14, 28, and 35 days after the conclusion of treatment. Additionally, the 1,8-cineole concentration in exhaled air, mucous secretions, and saliva will be measured using the High-Speed GS-MS method. The ability of antimicrobials to eradicate MRSA biofilm will be assessed in a controlled in vitro study.
Inclusion and Exclusion Criteria
Inclusion Criteria
- Willing and able to give informed consent to participate in the study.
- Patients aged between 18 and 70 years with positive nasal swabs for MRSA strains.
- Presence of MRSA strains in nasal swab cultures taken at the first initial screening visit (V0).
- 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
- Pregnant or breastfeeding women.
- Contraindication to endoscopic examination of the nasal cavity.
- Use of other intranasal preparations.
- Patients requiring treatment with antibiotic or systemic corticosteroids.
- Past surgery in the nasal cavity or paranasal sinuses within the last 6 months.
- Presence of cystic fibrosis or ciliary dyskinesia.
- Presence of active cancer.
- Immunodeficiency.
- Past or current participation in another clinical trial within the past 3 months.
- 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.
- Use of the investigational medicinal product within 30 days prior to inclusion in the study.
- Hypersensitivity or allergy to mupirocin, 1,8-cineole, and/or any of the ingredients of the investigational medicinal product.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 Poland | Not Yet Recruiting | 01 Oct 2026 | 300 |
Sites & Investigators
Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
CINEOLE | Test | — | ORAL USE | 600 | 7 | SUB20486 |
MUPIROCIN | Comparator | — | INTRANASAL USE | 2 | 7 | SUB09093MIG |