For elimination/eradication of nasal carriage of staphylococci, including methicillin-resistant Staphylococcus aureus (MRSA)
Conditions
Interventions
Trade Name: MupiroNasal 20mg/g, nasal ointment
Pharmaceutical Form: Nasal ointment
INN or Proposed INN: Mupirocin
CAS Number: 8000026-92-8
Other descriptive name: MUPIROCIN CALCIUM
Concentration unit:
Sponsors
Antibiotic-Razgrad AD
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To evaluate the efficacy of MupiroNasal 2% nasal ointment in healthy subjects with nasal carriage of Staphylococcus aureus (S. aureus). - To compare the efficacy of MupiroNasal 2% nasal ointment with respect to the Reference medicinal product. ;Secondary Objective: - To evaluate the safety of the investigated medicinal product MupiroNasal 2% nasal ointment. - To compare the safety of MupiroNasal 2% nasal ointment with respect to the Reference medicinal product. ;Primary end point(s): Apparent Eradication of Nasal Carriage of Staphylococcus aureus, including MRSA.;Timepoint(s) of evaluation of this end point: The efficacy evaluation will be performed after the end of the full treatment period (5 days). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The Number of Subjects With Adverse Events and Changes in Vital Signs and Routine Haematology, Clinical Chemistry and Urinalysis Tests Assessed Over the Five Day Treatment Period and Follow-up 5 days after the end of the treatment.;Timepoint(s) of evaluation of this end point: The follow-up of the safety parameters is during the entire treatment period and 5 days after the end of the therapy. | — |
Countries
Bulgaria
Contacts
Public ContactMedical and Regulatory Affairs
Antibiotic-Razgrad AD
Outcome results
None listed