CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 146 enrolled
Drug / intervention
Mupirocin Ointment [Treatment] +1 moredrug
Likely dose
Mupirocin ointment applied topically (intermittent schedule)AI-extracted
Key inclusion· 2
  • Hospitalized patients with documented S. aureus infection (community or hospital-acquired) at Ann Arbor VA Medical Center, University of Michigan Medical Center, or St. Joseph Mercy Hospital, Ypsilanti
  • Able to provide written informed consent (patient, guardian, or next of kin)
Key exclusion· 6
  • Unable to cooperate with treatment or follow-up
  • Not likely to survive beyond one month or transferred to another acute care hospital
  • Requiring concurrent treatment with rifampin
  • Known hypersensitivity to mupirocin ointment or polyethylene glycol base

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00108160
NCT00108160Phase 4Completed

Intermittent Mupirocin to Prevent Staphylococcal Infection

US Department of Veterans Affairs·interventional·Posted Apr 15, 2005·Updated Apr 16, 2014

In Brief

A Phase 4 clinical trial evaluating Mupirocin Ointment [Treatment] and Polyethylene Glycol Ointment [Placebo] for Staphylococcal Infections. Completed, enrolled 146 participants across 1 site.

Detailed 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 \[Placebo Arm\].

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 15, 2005
Enrollment StartApr 1, 2005
Primary CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 7.3 yearsPosted 21.2 years ago

Interventions

Mupirocin Ointment [Treatment]drug

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.

Polyethylene Glycol Ointment [Placebo]drug

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.