Methicillin Resistant Staphylococcus Aureus Skin Infections Clinical Trial
Official title:
A 2X2 Phase III Open-label Clinical Trial of Therapy for Patients With Recurrent Methicillin Resistant Staphylococcus Aureus Infections: Topical Nasal & Body Decolonization and/or Environmental Decontamination vs. Standard of Care
This clinical trial tests the hypotheses that 1) body decolonization of patients with recurrent community-associated (CA) MRSA infections and their household members and 2) environmental decolonization of the patients' households 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., including Southern California.
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. Others suggest environmental
decontamination to help control recurrences or transmission within households. However,
there are no data that quantify the efficacy and safety of these approaches.
We will conduct a multi-center clinical trial to compare the efficacy and safety of body and
environmental decolonization regimens in the prevention of CA-MRSA infection. This trial is
being conducted at Kaiser Permanente Southern California (KPSC) sites among KPSC enrollees.
The study population will comprise of persons suffering from recurrent CA-MRSA infection.
Household members of this "index subject" will also be offered the chance to enroll in the
study. For this clinical trial, all subjects will be randomized in a 2 x 2 design to test:
1) chlorhexidine body washes and nasal mupirocin ointment vs. usual care, and 2)
environmental cleansing with ethanol spray and aggressive laundering vs. no environmental
cleansing. Household members, should they consent, will also be enrolled into the study into
the same treatment arm as "index subjects". We will also perform selected secondary
analyses, including studying the efficacy of the interventions at preventing infections in
household members. Additionally, we will examine strain relatedness of colonizing and
infecting CA-MRSA strains to better understand colonization dynamics within households.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01049438 -
A Prospective Trial of Nasal Mupirocin, Hexachlorophene Body Wash, and Systemic Antibiotics for Prevention of Recurrent Methicillin Resistant Staphylococcus Aureus Infections
|
N/A |