Clinical study comparing the action and the safety of two approved drugs for nasal application,containing the same active substance - mupirocin.

Phase 1

• Conditions: For elimination/eradication of nasal carriage of staphylococci, including methicillin-resistant Staphylococcus aureus (MRSA); Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2018-002913-37-BG
• Lead Sponsor: Antibiotic-Razgrad AD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-12-28
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

•Male or female subject between 18 to 75 years inclusive;
•Judged clinically healthy from a medical history and medical examination (vital signs, axillary body temperature);
•Clinical-laboratory examinations within the reference ranges or with no clinically significant abnormalities;
•Negative pregnancy test for the women with reproductive potential;
•Reliable and acceptable method of contraception for the women of child-bearing potential:
•Asymptomatic S. aureus carriage has been established in two sequential microbiological swabs in both right and left anterior nares;
•Treatment area amenable to topical treatment, i.e. anterior nares should be free of any obstructions and tissue damage.
•In the investigator’s opinion, the subject is capable of giving informed consent;
•In the investigator’s opinion, the subject is able to understand, willing and likely to fully comply with study procedures and restrictions;
•The subject is able to attend all visits, complete the study, and comply with the necessary restrictions.

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 260
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

•Subjects with any physical or behavioral disorder, which, in the opinion of the Investigator, may interfere with the correct therapy with the IMPs or compliance with the Study Protocol requirements;
•Subjects demonstrating any symptoms or sign of active infections or abnormality that may affect the microbiology tests or the treatment:
-wound lesions and/or infections in the treated area and/or the skin or the soft tissues;
-has active hay fever, on-going cold/flu symptoms, or a clinically significant history or currently active rhinitis;
-has any structural abnormalities of the nose or nasal piercings;
•Any clinically significant allergy, including known allergy to mupirocin or any of the excipients or known drug intolerance;
•Use of concomitant medication, such as:
-use of systemic or topical antibiotics (including mupirocin) or systemic treatment with immunosuppressive drugs e.g. cyclosporine, azathioprine or oral corticosteroids within 4 weeks prior to Day 0;
-use of any prescribed medication in the 2 weeks prior to Day 0;
-use of any non-prescribed medication (including herbal remedies, nutritional supplements or vitamins and minerals) in the 1 week prior to Day 0;
-participation in a clinical study where the final dose of a New Chemical Entity occurred within the previous 16 weeks to Day 0;
-participation in a clinical study where the final dose of a marketed drug occurred within the previous 12 weeks or at least 5 half-lives (whichever is longest) of Day 0.
•Subjects suffering from or with a history for systemic diseases or alterations, such as: haematological, dermatological, renal, hepatic, endocrine, pulmonary, gastrointestinal, cardiovascular, respiratory, psychiatric, neurological disease;
•Subjects, suffering from or who have history of immune system disorders, such as autoimmune diseases, HIV positive status, history of immune system degradation or recurrent herpes simplex or who are undergoing treatment with immunosuppressors or immunotherapy;
•Subjects who suffer from another medical condition or who are receiving medication that in the Principal Investigator’s judgment would prohibit inclusion in the study;
•History of known alcohol or substance abuse;
•Refusal to sign the Informed Consent Form.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified