Clinical trial confirming the efficacy of 1.8-cineole (18C) in the treatment of MRSA staphylococcal carriage

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Wroclaw Medical University

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Otorhinolaryngologic Diseases [C09]

Decision date (initial)

2026-04-07

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Agencja Badań Medycznych (ABM)

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Safety, Efficacy, Pharmacokinetic

The main objective of the study is the evaluation of the effectiveness of 1,8-cineole treatment of the MRSA bacterial nasal cavity infections. Evaluation will be carried out by microbiological examination (nasal cavity culture) immediately after 7 days of therapy.

Secondary objectives 2

1. the evaluation of the effectiveness of the 1,8-cineole in preventing postnasal carriage with MRSA bacterial strains (evaluation will be based on smear results (nasal cavity culture) at 7, 14, 21 and 35 days after the end of therapy)
2. the pharmacokinetic evaluation of the concentration of orally administered 1,8-cineole based on the extended diagnostic tests performed (exhaled air, mucous secretions, saliva measured by High-Speed GS-MS)

Conditions and MedDRA coding

chronic active Staphylococcus aureus mono-infection/asymptomatic carriage in the nasal cavity

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Willing and able to give informed consent to participate in the study.
2. Patients aged between 18 and 70 years with positive nasal swabs for MRSA strains.
3. Presence of MRSA strains in nasal swab cultures taken at the first initial screening visit (V0).
4. 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 12

1. Pregnant or breastfeeding women.
2. Contraindication to endoscopic examination of the nasal cavity.
3. Use of other intranasal preparations.
4. Patients requiring treatment with antibiotic or systemic corticosteroids.
5. Past surgery in the nasal cavity or paranasal sinuses within the last 6 months.
6. Presence of cystic fibrosis or ciliary dyskinesia.
7. Presence of active cancer.
8. Immunodeficiency.
9. Past or current participation in another clinical trial within the past 3 months.
10. 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.
11. Use of the investigational medicinal product within 30 days prior to inclusion in the study.
12. Hypersensitivity or allergy to mupirocin, 1,8-cineole, and/or any of the ingredients of the investigational medicinal product.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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.

Secondary endpoints 7

1. decrease in the prevalence of MRSA Staphylococcus aureus carriage (based on the results of the culture)
2. decrease in the number of bacteria in nasal swabs (based on the results of the quantitative test)
3. clinical improvement (according to the Lund-Kennedy endoscopic assessment scale, VAS pain severity score)
4. ability of applied antimicrobials to eradicate MRSA biofilm in the controlled in vitro study
5. improvement in quality of life (assessed by the SNOT-22 - Sino-nasal Outcome Test questionnaire)
6. 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)
7. the level of 1,8- cineole concentration in the tested samples (in exhaled air, mucous secretions, saliva measured by High- Speed GS-MS method)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Wroclaw Medical University

Sponsor organisation

Wroclaw Medical University

Address

Ul. Wybrzeze Ludwika Pasteura 1

City

Wroclaw

Postcode

50-367

Country

Poland

Scientific contact point

Organisation

Wroclaw Medical University

Contact name

Prof. Tomasz Zatoński

Public contact point

Organisation

Wroclaw Medical University

Contact name

Information desk

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 12 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications