Study to Assess Eradication of Nasal Carriage of Staphylococcus Aureus (SA) With Mupirocin (Bactroban 2% Nasal Ointment)
Condition: Staphylococcal Infection
MeSH terms: Staphylococcal Infections
Intervention: Mupirocin
Intervention description: Mupirocin (Bactroban 2% Nasal Ointment) will be administered twice daily for five days in accordance with the SmPC.
Intervention MeSH terms: Mupirocin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will assess the nasal eradication of SA in healthy subjects following treatment
      with mupirocin 2% (Bactroban 2% Nasal Ointment) twice daily for 5 days, by means of a broth
      enriched culture microbial assay. The sensitivities of broth enrichment and plating assay
      methods will be compared. The safety and tolerability of Bactroban 2% Nasal Ointment will
      also be assessed.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Normal, healthy male or female subjects aged between 18 and 75 years.

          2. Subjects confirmed to be persistent nasal SA carriers, defined by 3 separate, SA
             positive cultures from nasal swabs. Two positive cultures should be obtained at
             screening visits up to 12 weeks prior to inclusion and at least two weeks apart. The
             final confirmatory culture should be obtained from a baseline nasal swab prior to
             administration of the first dose.

          3. Subjects who are able and willing to provide written informed consent to participate
             in the study

          4. Subjects who have a body mass index (BMI) ≥18.5 kg/m2 and ≤ 32 kg/m2.

          5. Subjects who agree not to take part in another clinical trial at any time during the
             study period.

        Exclusion Criteria:

          1. Female subjects who are or may be pregnant or who are lactating.

          2. Subjects who have any acute or chronic illness or infection.

          3. Subjects who have smoked within the 3 months prior to screening (confirmed by urinary
             cotinine test).

          4. Subjects who are females of child-bearing potential, defined as being physiologically
             capable of becoming pregnant, UNLESS using one or more of the following acceptable
             methods of contraception; established use of oral, injected or implanted hormonal
             contraception, intrauterine Device (IUD or Coil AND barrier Method (condom or
             diaphragm or cervical/vault cap) plus spermicidal cream/gel. Contraceptive use should
             continue throughout the study and for 1 month following completion of the study.

          5. Subjects who are fertile males, defined as all males physiologically capable of
             conceiving offspring, UNLESS the subject agrees to comply with acceptable
             contraception e.g. condom plus spermicidal cream/gel. Contraceptive use should
             continue throughout the study and for 3 months following completion of the study.

          6. Subject with any open wound, lesion, inflammation, erythema or infection affecting the
             nostrils, nose, upper lip and area of skin close to the nose. This includes herpes
             simplex lesions and discoid lupus.

          7. Subjects who have a currently symptomatic upper respiratory tract infection,
             nasopharyngitis, influenza or condition involving increase in nasal secretion such as
             seasonal or chronic, allergic rhinitis.

          8. Subjects with a history of drug or alcohol abuse in the previous 12 months or who have
             a positive urine drug test for substances of abuse.

          9. Subjects with a known clinically significant history of atopy or hypersensitivity to
             any drug or latex.

         10. Subjects with a history of serious illness, cancer or psychiatric condition.

         11. Subjects who have been treated with or have taken any prescribed or over-the-counter
             medication within the previous 14 days, with the exception of hormonal contraceptives
             or hormone replacement therapy.

         12. Subjects who have taken or used topical or systemic antibiotics within the month prior
             to screening.

         13. Subjects who are known to have serum hepatitis, or who are carriers of the hepatitis B
             surface antigen (HBsAg) or hepatitis C antibody, or who have a positive result to the
             test for human immunodeficiency virus (HIV) antibodies

         14. Subjects who have participated in a clinical trial within the last 3 months.

         15. Subjects with any clinically significant abnormality in vital signs or laboratory
             analyses at screening or at baseline, based on the opinion of the investigator.

         16. Subjects with nasal polyps or significant anatomical nasal abnormality.

         17. Subjects with a history of nasal surgery, including cauterization in the last 12
             months.

         18. Subjects with a history of multiple episodes [>3] of epistaxis within the last 12
             months.

         19. Subjects with in-situ nasal jewellery or open nasal piercings.

         20. Subjects with a history of abnormal bleeding, bruising, frequent nosebleeds or a
             diagnosis of von Willebrand disease.

         21. Subjects who have or have had an autoimmune disease.

         22. Subjects with hypersensitivity to any of the ingredients of Bactroban® Nasal Ointment
             i.e. mupirocin, white soft paraffin, Softisan 649 (mixed diglycerinester of fatty
             acids).