MRSA - Methicillin Resistant Staphylococcus Aureus Infection
Conditions
Keywords
MRSA; household; infection; colonization
Brief summary
The overall goal of this project is to elucidate the epidemiology of MRSA transmission in the community and test an intervention to prevent MRSA transmission in this setting.
Detailed description
The overall goals of this project are to: 1. to investigate the determinants of and evaluate potential interventions to reduce the spread of methicillin resistant Staphylococcus aureus (MRSA) infections in community settings in order to reduce the burden of this illness in the State of Pennsylvania. This objective has the following specific aims: * to identify host, microbiological and environmental risk factors for prolonged MRSA colonization, MRSA transmission and clinical MRSA infection among patients with MRSA skin and soft tissue infections (SSTIs) and their household contacts and to use stochastic agent-based modeling methods to quantify secondary spread of CO-MRSA in households. * to evaluate the impact of a decolonization intervention on MRSA infections in the household. * to identify immunological mechanisms underlying the ability of Streptococcus pneumoniae colonization to inhibit MRSA colonization, transmission and infection in order to identify potential future immunological targets for interventions. 2. to foster multi-disciplinary and cross-institutional collaborations and develop the infrastructure for a Center of Excellence focused on antimicrobial drug resistance research, with the capacity for activities linking basic science, epidemiological and clinical intervention studies 3. to enhance opportunities for basic and clinical research training for undergraduate and graduate students, particularly from underrepresented minorities, in order to increase the pipeline of future biomedical scientists and clinical investigators
Interventions
DRUGUnsupervised Decolonization
Households will undergo decolonization for MRSA with Mupirocin nasal ointment and Hibiclens body wash. This means that the intervention includes applying Mupirocin ointment twice daily in each nostril for the first 7 days of study enrollment as well as using Hibliclens body wash twice total (on day 1 and day 7 of study enrollment) according to the instructions provided. Households are given detailed, written instructions and are asked to fill out logs tracking compliance for each household member.
DRUGSupervised Decolonization
Households will undergo decolonization for MRSA with Mupirocin nasal ointment and Hibiclens body wash. This means that the intervention includes applying Mupirocin ointment twice daily in each nostril for the first 7 days of study enrollment as well as using Hibliclens body wash twice total (on day 1 and day 7 of study enrollment) according to the instructions provided. Households are given detailed, written instructions and are asked to fill out logs tracking compliance for each household member. In addition, households are contacted by study stuff via phone or text messages to ensure compliance, to provide reminders to household members to perform the decolonization protocol as well as to answer any question/concerns household members may have.
Sponsors
Pennsylvania Department of Health
Children's Hospital of Philadelphia
Milton S. Hershey Medical Center
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
No
Inclusion criteria
* All members of a household in which the index case is treated for a skin or soft tissue infection due to MRSA. All household members must agree to participate in order for the household to be enrolled
Exclusion criteria
* Prior MRSA within past 6 months in the index case; age less than 6 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrent Infection | Within 6 months | Confirmed new MRSA infections |
| First Two Consecutive Sampling Periods Completed | Within 2 months | Subjects who returned samples for at least the first two consecutive sampling periods were included in analysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Clearance of Methicillin-resistant Staphylococcus Aureus (MRSA) Colonization | Within 6 months | Surveillance cultures negative for two consecutive sampling periods; date of clearance determined as midpoint between date of last positive surveillance culture and first negative surveillance culture. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Unsupervised Decolonization This group was randomized to the following decolonization protocol: 1) 2% mupirocin ointment applied inside both nares twice daily for seven days 2) a 4% chlorhexidine gluconate (Hibiclens, Mo¨lnlycke Health Care, Norcross, Georgia) body wash, including entire skin surface, excluding face and hair, with particular attention to axillae, inguinal region, and perirectal areas, performed on both the first and the last day of mupirocin use. Subjects were asked to record performance of each step of the decolonization protocol in a journal, which was returned at the end of the period of medication use, along with any unused portion of the mupirocin and chlorhexidine gluconate body wash containers. The subjects randomized to unsupervised decolonization were instructed on the decolonization protocol during the initial interview, along with the educational instruction as described in the no intervention group. | 76 |
| Supervised Decolonization This group was also randomized to the decolonization protocol. In addition those randomized to supervised decolonization received daily phone calls or text messages during the decolonization protocol period in order to remind enrolled subjects to perform the indicated procedure in addition to the instruction and education received during the initial interview. | 74 |
| No Intervention Households do not undergo active MRSA decolonization protocol. The received education only. The content of the education focused on personal hygiene (hand hygiene and bathing), interrupting transmission (avoidance of shared towels, razors, etc.), and household hygiene (regular washing of linens and towels, disposal of potentially infective materials such as bandages). | 73 |
| Total | 223 |
Baseline characteristics
| Characteristic | Total | Unsupervised Decolonization | Supervised Decolonization | No Intervention |
|---|---|---|---|---|
| Age, Categorical <=18 years | 110 Participants | 35 Participants | 37 Participants | 38 Participants |
| Age, Categorical >=65 years | 7 Participants | 2 Participants | 2 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 106 Participants | 39 Participants | 35 Participants | 32 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants | 6 Participants | 5 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 203 Participants | 68 Participants | 67 Participants | 68 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants | 2 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 135 Participants | 41 Participants | 47 Participants | 47 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 1 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 11 Participants | 2 Participants | 5 Participants | 4 Participants |
| Race (NIH/OMB) White | 72 Participants | 32 Participants | 20 Participants | 20 Participants |
| Region of Enrollment United States | 223 participants | 76 participants | 74 participants | 73 participants |
| Sex: Female, Male Female | 128 Participants | 40 Participants | 43 Participants | 45 Participants |
| Sex: Female, Male Male | 95 Participants | 36 Participants | 31 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 17 / 76 | 29 / 74 | 0 / 73 |
| serious Total, serious adverse events | 5 / 76 | 7 / 74 | 4 / 73 |
Outcome results
Primary
First Two Consecutive Sampling Periods Completed
Subjects who returned samples for at least the first two consecutive sampling periods were included in analysis
Time frame: Within 2 months
Population: These subjects sent in two consecutive swab samples starting with their first follow-up time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Unsupervised Decolonization | First Two Consecutive Sampling Periods Completed | 48 participants |
| Supervised Decolonization | First Two Consecutive Sampling Periods Completed | 49 participants |
| No Intervention | First Two Consecutive Sampling Periods Completed | 52 participants |
Primary
Recurrent Infection
Confirmed new MRSA infections
Time frame: Within 6 months
Population: These study participants who self-reported re-infections of MRSA
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Unsupervised Decolonization | Recurrent Infection | 1 participants |
| Supervised Decolonization | Recurrent Infection | 3 participants |
| No Intervention | Recurrent Infection | 1 participants |
Secondary
Time to Clearance of Methicillin-resistant Staphylococcus Aureus (MRSA) Colonization
Surveillance cultures negative for two consecutive sampling periods; date of clearance determined as midpoint between date of last positive surveillance culture and first negative surveillance culture.
Time frame: Within 6 months
Population: Subjects who returned samples for at least the first two consecutive sampling periods were included in analysis, as this was necessary to determine clearance of MRSA colonization
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Unsupervised Decolonization | Time to Clearance of Methicillin-resistant Staphylococcus Aureus (MRSA) Colonization | 23 days |
| Supervised Decolonization | Time to Clearance of Methicillin-resistant Staphylococcus Aureus (MRSA) Colonization | 23 days |
| No Intervention | Time to Clearance of Methicillin-resistant Staphylococcus Aureus (MRSA) Colonization | 19 days |