Phase 4
N=146
Preventing Staphylococcal (Staph) Infection
Staphylococcal Infections
Bottom Line
View on ClinicalTrials.gov: NCT00108160 ↗Enrolled (actual)
146
Serious AEs
2.1%
Results posted
Feb 2014
Primary outcome: Primary: Re-infection With S. Aureus — 10; 11; 0; 0 participants with S. aureus re-infection — p=0.356
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Mupirocin Ointment [Treatment] (Drug); Polyethylene Glycol Ointment [Placebo] (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- US Department of Veterans Affairs
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Re-infection With S. Aureus |
10; 11; 0; 0; 1; 0 | 0.356 |
| SECONDARY Acquisition of New S. Aureus Strains |
10; 10; 8; 10; 2; 0 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00108160). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.