Methicillin Resistant Staphylococcus Aureus Skin Infections Clinical Trial
Official title:
A Prospective Trial of Nasal Mupirocin, Hexachlorophene Body Wash, and Systemic Antibiotics for Prevention of Recurrent Methicillin Resistant Staphylococcus Aureus Infections
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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00560599 -
A Randomized Clinical Trial to Prevent Recurrent CA-MRSA Infection
|
Phase 3 |