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A study evaluating the effectiveness of cineole compared to mupirocin in patients with chronic Staphylococcus aureus infection or carriage in the nasal cavity.

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on individuals with chronic rhinitis, which is a long-term inflammation of the nose, specifically caused by the presence of Staphylococcus aureus in the nasal cavity. This condition involves the carrying of bacteria in the nose, including a specific type known as methicillin-resistant Staphylococcus aureus, often referred to as MRSA. This type of bacteria is resistant to many common antibiotics, making it harder to eliminate.

The purpose of the study is to evaluate the effectiveness of CINEOLE compared to mupirocin. CINEOLE is an oral treatment containing cineole, while mupirocin is a medication used through the nose. Participants in the study will undergo a course of treatment to determine how well these substances can reduce the presence of the bacteria in the nasal passages.

During the study, participants will receive one of the treatments for a period of time. Following the treatment, medical evaluations will be conducted to monitor the bacteria levels through a nasal cavity culture, which is a laboratory test used to identify and count the germs present in the nose. Follow-up checks may also be performed to see how long the effects of the treatment last.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    <b>treatment administration</b>

    Administration of either cineole or mupirocin begins.

    If assigned to cineole, a dose of 600 mg is taken by mouth.

    If assigned to mupirocin, a dose of 2 units is applied inside the nose.

  2. Step 2

    <b>initial assessment</b>

    A microbiological examination, which involves a culture to check for bacteria in the nasal cavity, is performed immediately after 7 days of treatment.

  3. Step 3

    <b>follow-up monitoring</b>

    Further microbiological examinations are conducted to check the durability of the effect. these tests occur at 7, 14, 28, and 35 days after the treatment has finished.

Who can join the trial?

7 criteria

  • You must be willing and able to provide informed consent, which means you agree to participate in the study after understanding all the details and risks.
  • You must be between 18 and 70 years old.
  • You must have tested positive for MRSA (a type of bacteria that is resistant to many common antibiotics) in a nasal swab (a test where a small piece of cotton is rubbed inside the nose to collect a sample).
  • The presence of MRSA must be confirmed during your first visit to the study site.
  • Women who cannot have children due to surgery (removal of the uterus or both ovaries) or who have gone through menopause (the time when a woman no longer has monthly periods, defined here as at least 12 months since the last period) do not need pregnancy tests.
  • Women who are able to have children must have a negative pregnancy test before the first dose of medicine, agree to regular pregnancy tests during the study, and use contraceptives (methods used to prevent pregnancy, such as birth control) for one month after the treatment ends.
  • Men must agree to use highly effective methods to avoid fathering a child or agree not to donate sperm from the start of the study until 30 days after the treatment is finished.

Who cannot join the trial?

12 criteria

  • Women who are pregnant or breastfeeding.
  • Any medical, physical, or mental condition that, according to the researcher, would make it difficult to participate in the study, prevent you from taking the study medicine, or make it hard to follow the study schedule.
  • Having used the study medicine (the product being tested) within the 30 days before starting the study.
  • Having an allergy or hypersensitivity (an extreme immune reaction) to mupirocin, 1,8-cineole, or any of the other ingredients in the study medicine.
  • Having any reason why an endoscopic examination—a procedure where a doctor uses a small tube with a camera to look inside the nasal cavity (the inside of the nose)—cannot be performed safely.
  • Using any other nasal preparations (medicines or sprays applied inside the nose).
  • Needing treatment with antibiotics (medicines used to kill bacteria) or systemic corticosteroids (strong medicines used to reduce inflammation throughout the entire body).
  • Having had surgery in the nasal cavity or the paranasal sinuses (the air-filled spaces around the nose) within the last 6 months.
  • Having cystic fibrosis (a genetic disorder that affects the lungs and digestive system) or ciliary dyskinesia (a condition where the tiny hairs in the airways do not move correctly).
  • Having active cancer.
  • Having an immunodeficiency (a condition where the body's immune system is weakened and cannot fight infections well).
  • Having participated in another clinical trial (a research study testing new treatments) within the last 3 months.
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Investigated drugs

  • Cineole

    is an oral medication being tested to see if it can help treat infections in the nose caused by a specific type of bacteria.

  • Mupirocin

    is a medication applied inside the nose to compare its effectiveness against the test treatment in clearing bacteria from the nasal cavity.

What is already known about the treatment

  • Cineole

    This medication is taken by mouth as a pill or capsule to help treat respiratory issues. It is a natural substance widely used in medicine to reduce inflammation and help clear airways. It works by decreasing swelling in the body and helping to loosen mucus, making it easier to breathe. This substance is classified as an essential oil with anti-inflammatory and soothing properties.

  • Mupirocin

    This medication is applied directly into the nose to treat bacterial infections. It is a well-established antibiotic used to kill specific bacteria that live in the nasal cavity. It works at a molecular level by blocking the bacteria's ability to build essential proteins, which prevents them from growing and multiplying. This substance is classified as a topical antibiotic.

Investigated diseases

Staphylococcus aureus nasal infection - This condition occurs when a specific type of bacteria resides in the nasal passages. It can exist as an asymptomatic carriage, where the bacteria are present without causing noticeable symptoms. In other cases, it may develop into a chronic active infection, leading to ongoing irritation or inflammation in the nose. The bacteria can sometimes form a protective layer called a biofilm, which makes them harder to remove. The condition is characterized by the presence or growth of these bacteria within the nasal cavity.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-521569-29-00Protocol code2024/ABM/01/00042Estimated enrolment300 patientsSponsorAgencja Badań Medycznych

sourced from the EU Clinical Trials Register and site verification

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