Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01049438 |
| Other study ID # |
20020519 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
January 13, 2010 |
| Last updated |
January 13, 2010 |
| Start date |
August 2006 |
| Est. completion date |
September 2009 |
Study information
| Verified date |
January 2010 |
| Source |
Natividad Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Institutional Review Board |
| Study type |
Interventional
|
Clinical Trial Summary
This clinical trial tests the hypothesis that body decolonization of patients with recurrent
community-associated (CA) MRSA infections will significantly reduce the likelihood of
recurrent CA-MRSA infection.
Description:
Staphylococcus aureus is a ubiquitous pathogen, and causes infections of the skin, lung,
bloodstream, and other body parts. Over the past decade,community-acquired methicillin
resistant S. aureus (CA-MRSA) infections, which were previously extremely rare, are
occurring commonly worldwide. CA-MRSA is the most common cause of skin infection in many
locales in the U.S.
CA-MRSA strains are notable for their ability to spread in closed settings and cause
recurrent infections among healthy persons. Management of recurrent CA-MRSA infection is
challenging and optimal prevention strategies are undefined. Many experts recommend topical
agents that decontaminate the body and/or anterior nares. However, there are no data that
quantify the efficacy and safety of this approach.
We conducted a prospective non-comparative clinical trial to quantify the efficacy and
safety of body decolonization regimens in the prevention of CA-MRSA infection from an
Infectious Diseases private practice group in Northern California.
The study population comprised of persons suffering from recurrent CA-MRSA infection. For
this clinical trial, all subjects will be given: nasal mupirocin (Bactroban Nasal, twice
daily), topical 3% hexachlorophene body wash (Phisohex, daily), and an oral anti-MRSA
antibiotic. The choice of oral antibiotic was based on investigators choice and antibiotic
susceptibility of prior MRSA isolates in a given patient.
Patients were interviewed in person baseline and by phone at 2 weeks, 3 months, and 6 months
using a standardized questionnaire. The baseline survey, based on a previously developed
instrument used for an epidemiologic investigation of MRSA asked about MRSA risk factors and
health-related quality of life. Follow up surveys asked about adverse drug effects,
especially gastrointestinal and dermatologic side effects (2 week visit only) and incident
skin and MRSA infections.
