Effect of Exeporfinium Chloride (XF-73) Gel on Nasal S.Aureus in Patients at Risk of Post-op Staphylococcal Infection
Condition: Staphylococcal Infections; Surgical Site Infection
MeSH terms: Infections; Communicable Diseases; Surgical Wound Infection; Staphylococcal Infections
Intervention: XF-73; Placebo
Intervention description: XF-73 is a dicationic porphyrin derivative having potent bactericidal properties with a novel mode of action.; Placebo to match XF-73 nasal gel for colour and viscosity.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: Double blind.
Enrollment: 124.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Post-operative; Post-surgical; Infection prevention; Staphylococcus aureus; MSSA; MRSA

Summary:

      This study looks at the difference between XF-73 and placebo in reducing the carriage of a
      bacteria S. aureus in the nose before, during and after heart surgery. Only people who
      normally have S.aureus in their nose will be enrolled onto the study. This will be confirmed
      by analysis of a nasal swab (a cotton bud placed in the nose) before entering the study. It
      is expected 125 people will participate in this study. Participation will be confirmed by
      analysis of a nasal swab (a cotton bud placed in the nose) before entering the study. XF-73
      or placebo will be given 5 times, with an equal chance of participants receiving either XF-73
      or placebo. During the hospital stay more nasal swabs will be taken to determine the amount
      of S.aureus present in the participant's nose. Other tests such as blood samples, blood
      pressure and an examination of the nose and sense of smell will be performed as part of the
      safety assessment. After the hospital stay participants will be followed up for 30 days or if
      a device has been inserted into the body as part of the surgery for 90 days to look at the
      rates of post-operative infection between the placebo and XF-73 groups. The study will run
      for about 18 months. During this period, an independent data monitoring committee will review
      the study to make sure that the balance of benefits and risks of participating in the study
      does not change.
    

Eligibility criteria:

        Individuals who meet all of the following criteria are eligible to participate in the
        study.

          1. Male or female patients between 18 and 75 years of age.

          2. Patients who are confirmed nasal S. aureus carriers by polymerase chain reaction (PCR)
             screen assay, and due to undergo surgical procedure.

          3. Patients who are willing to provide written informed consent.

          4. Patients who are willing and able (as per Investigator judgment) to complete all
             protocol specified visits and assessments.

          5. Woman of childbearing potential* with a negative urine pregnancy test (sensitive to 25
             IU human chorionic gonadotropin (hCG)).

               -  Women of childbearing potential are defined as those women between menarche and
                  menopause who have not undergone permanent sterilisation. Permanent sterilisation
                  methods include hysterectomy, bilateral salpingectomy, and bilateral
                  oophorectomy.

        Individuals who meet any of the following criteria are not eligible to participate in the
        study.

          1. Pregnancy (current) or currently lactating.

          2. Uncontrolled acute or chronic illness (as determined by the investigator) in addition
             to those requiring the planned surgical intervention.

          3. History of atopy, allergic reactions or hypersensitivity to the study medication or
             its components.

          4. Current upper respiratory tract infection, cold or influenza with significant nasal
             symptoms that might impact on the patient's ability to comply with the gel application
             procedure.

          5. History of photosensitivity.

          6. Family history of porphyria.

          7. Use of intra-nasal topical or systemic antibiotics or anti-infectives within the last
             4 weeks before screening. (Patients who screen positive for nasal carriage of S.
             aureus and receive topical or systemic antibiotics or anti-infectives which are not
             part of their prophylactic peri-operative SOC between screening and first dose of
             investigational medicinal product (IMP) will be excluded from the study.) The use of
             intra-nasal antibiotics or anti-infectives other than the study medication prior to
             surgery is not allowed.

          8. Use of other prescribed or over the counter nasal medication in the last 14 days, or
             oral decongestants in the last 7 days before first administration of study drug.

          9. Participation in a clinical trial within the last 12 weeks before first administration
             of study drug.

         10. Contemporaneous clinically significant abnormalities in vital signs or laboratory
             analyses reported within 14 days prior to randomization which in the opinion of the
             Investigator would preclude from the safety assessment of the medication under study.

         11. Nasal polyps or significant anatomical or other nasal abnormality that would prevent
             from appropriate administration of the study treatment or represent an excessive risk
             for the patient's participation.

         12. History of nasal surgery including cauterization.

         13. A recent history of frequent epistaxis and/or an episode of epistaxis within 3 months
             of the planned surgery.

         14. Use of in situ nasal jewellery or existence of open nasal piercings.