Preventing Staphylococcal (Staph) Infection
Condition: Staphylococcal Infections
MeSH terms: Infections; Communicable Diseases; Staphylococcal Infections
Intervention: Mupirocin Ointment [Treatment]; Polyethylene Glycol Ointment [Placebo]
Intervention description: The impact of the treatment arm versus placebo arm on development of new (recurrent) S. aureus infection will be assessed as the primary end point. Change in S. aureus strains (MSSA versus MRSA) will be assessed as the secondary end point.; The impact of the treatment arm versus placebo arm on development of S. aureus re-infections will be assessed as the primary end point. Change in S. aureus strains (MSSA versus MRSA) will be assessed as the secondary end point.
Intervention MeSH terms: Mupirocin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 146.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: mupirocin; prevention and control; s. aureus

Summary:

      The purpose of this study is to determine if mupirocin 2% in polyethylene glycol (PEG)
      ointment [Treatment Arm] is effective in preventing moderate to severe re-infection with
      Staphylococcus aureus compared with treatment with polyethylene glycol (PEG) ointment
      [Placebo Arm].
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients who receive care at Ann Arbor VA Medical Center, University of Michigan
             Medical Center, or St. Joseph Mercy Hospital, Ypsilanti who have been hospitalized for
             documented S. aureus infection will be eligible for enrollment. Staphylococcal
             infections may be community or hospital-acquired. Patients with S. aureus infection
             will be identified on a daily basis with the assistance of the Infection Control
             Practitioner, the Clinical Microbiology Laboratory, the Infectious Diseases
             Consultation Services, and Infectious Diseases physicians caring for patients in their
             offices.

          -  Patients will provide written informed consent. The patient's guardian or next of kin
             will be contacted for informed consent in the event that the patient is incapable of
             doing so.

        Exclusion Criteria:

          -  Patients who are unable to cooperate with treatment or follow-up.

          -  Patients who are not likely to survive beyond one month or those who are transferred
             back to another acute care hospital.

          -  Patients who require treatment with rifampin will be excluded since this drug is
             effective in decolonization of some staphylococcal carriers.

          -  Patients with known hypersensitivity to mupirocin ointment or polyethylene glycol
             base.

          -  Patients with ulcers obviously related to pressure will be excluded because they are
             frequently large, difficult to keep clean, and infections are difficult to diagnose.

          -  Patients with small vascular or neuropathic ulcers < 3 cm in circumference and < 2 cm
             in depth may be enrolled.

          -  Pregnant women.