Epidemiology and Prevention of Methicillin Resistant Staphylococcus Aureus (MRSA) Transmission in the Community

ID: NCT00966446
Status: Completed
Phase: N/A
Start Date: September 01, 2009
First Submitted: August 25, 2009
Last Updated: February 05, 2018
Results: Available
Success Rate: 66%
Sponsors & Collaborators: University of Pennsylvania, Pennsylvania Department of Health, Children's Hospital of Philadelphia, Milton S. Hershey Medical Center
Location: United States
Conditions: MRSA - Methicillin Resistant Staphylococcus Aureus Infection
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

Study Description

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
Condition or disease Intervention/treatment Phase

MRSA - Methicillin Resistant Staphylococcus Aureus Infection

Drug: Unsupervised Decolonization
Other Names
Experimental: Unsupervised Decolonization
Drug: Supervised Decolonization
Other Names
Experimental: Supervised Decolonization
N/A

Tracking Information

First Submitted DateAugust 25, 2009
Last Update Posted DateFebruary 05, 2018
Start DateSeptember 01, 2009
Actual Completion DateDecember 01, 2014
Primary Completion DateSeptember 01, 2014
Results First Submitted DateDecember 01, 2015
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Recurrent Infection [Time Frame: Within 6 months]

    Confirmed new MRSA infections

  • First Two Consecutive Sampling Periods Completed [Time Frame: Within 2 months]

    Subjects who returned samples for at least the first two consecutive sampling periods were included in analysis

Original Primary Outcome Measures

  • First Two Consecutive Sampling Periods Completed

    Subjects who returned samples for at least the first two consecutive sampling periods were included in analysis

  • Recurrent Infection

    Confirmed new MRSA infections

Current Secondary Outcome Measures

  • Time to Clearance of Methicillin-resistant Staphylococcus Aureus (MRSA) Colonization [Time Frame: 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.

Original Secondary Outcome Measures

  • 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.

Study Design

Brief TitleEpidemiology and Prevention of Methicillin Resistant Staphylococcus Aureus (MRSA) Transmission in the Community
Official TitleEpidemiology and Prevention of MRSA Transmission in the Community
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

Study TypeInterventional
Study PhaseN/A
Estimated Enrollment
223
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
None (Open Label)
Primary Purpose
Prevention
Conditions
MRSA - Methicillin Resistant Staphylococcus Aureus Infection
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: Unsupervised 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.

Other Names
Experimental: Unsupervised Decolonization
Drug: Supervised 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.

Other Names
Experimental: Supervised Decolonization
Study Groups/Cohorts
Unsupervised Decolonization
Households undergo decolonization for MRSA. The intervention includes applying Mupirocin ointment twice daily 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.

Supervised Decolonization
Households undergo decolonization for MRSA. The intervention includes applying Mupirocin ointment twice daily 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. Study staff is in contact with household members during this intervention to ensure compliance.

No Intervention
Households do not undergo active MRSA decolonization protocol

Study Arms
Experimental Supervised Decolonization
Households undergo decolonization for MRSA. The intervention includes applying Mupirocin ointment twice daily 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. Study staff is in contact with household members during this intervention to ensure compliance.
Drug : Supervised 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.

Experimental Unsupervised Decolonization
Households undergo decolonization for MRSA. The intervention includes applying Mupirocin ointment twice daily 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.
Drug : Unsupervised 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.

Arm Intervention/Treatment
Experimental Supervised Decolonization
Households undergo decolonization for MRSA. The intervention includes applying Mupirocin ointment twice daily 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. Study staff is in contact with household members during this intervention to ensure compliance.
Drug : Supervised Decolonization
Experimental Unsupervised Decolonization
Households undergo decolonization for MRSA. The intervention includes applying Mupirocin ointment twice daily 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.
Drug : Unsupervised Decolonization

Recruitment Information

Recruitment Status:Completed
Enrollment223
Completion DateDecember 01, 2014
Eligibility Criteria: 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.
GenderAll
Age6 Months to N/A
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
United States

Administrative Information

NCT Number:NCT00966446
Other Study ID Numbers
809899
Has Data Monitoring CommitteeYes
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
University of Pennsylvania
Collaborators
Pennsylvania Department of Health
Children's Hospital of Philadelphia
Milton S. Hershey Medical Center
Investigators
Principal Investigator
Ebbing Lautenbach, MD
University of Pennsylvania

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Not Available

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Not Available

Reporting Groups

TitleDescription
Unsupervised Decolonization
Households undergo decolonization for MRSA. The intervention includes applying Mupirocin ointment twice daily 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. Unsupervised 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.
Supervised Decolonization
Households undergo decolonization for MRSA. Intervention includes applying Mupirocin ointment twice daily for the first 7 days of study enrollment AND using Hibliclens body wash twice total (day 1 and day 7 of study enrollment) according to the instructions provided. To ensure compliance, study staff is in contact with household members. Supervised Decolonization: Households will undergo decolonization for MRSA with Mupirocin nasal ointment and Hibiclens body wash. Intervention includes applying Mupirocin ointment twice daily in each nostril for the first 7 days of study enrollment AND using Hibliclens body wash twice total (day 1 and day 7 of study enrollment) according to the instructions provided. Households are asked to fill out logs tracking compliance for each household member. Study staff contacts households daily (phone/text) to ensure complicane, to provide reminders to household members to perform the decolonization protocol, and to answer study question/concerns.
No Intervention
Households do not undergo active MRSA decolonization protocol

Participant Flow: Overall

Unsupervised DecolonizationSupervised DecolonizationNo Intervention
Started767473
Completed484952
Not Completed282521

Baseline Characteristics

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Not Available

Reporting Groups

TitleDescription
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.
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.
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).
Total
Total of all reporting groups

Baseline Measures

Unsupervised DecolonizationSupervised DecolonizationNo InterventionTotal
Overall Participants Analyzed
Units: Participants
Participants Analyzed
767473223
767473223
Age
Units: Participants - Count of Participants
Participants Analyzed
767473223
<=18 years353738110
>=65 years2237
Between 18 and 65 years393532106
Sex: Female, Male
Units: Participants - Count of Participants
Participants Analyzed
767473223
Female404345128
Male36312895
Ethnicity (NIH/OMB)
Units: Participants - Count of Participants
Participants Analyzed
767473223
Hispanic or Latino65415
Not Hispanic or Latino686768203
Unknown or Not Reported2215
Race (NIH/OMB)
Units: Participants - Count of Participants
Participants Analyzed
767473223
American Indian or Alaska Native0000
Asian0112
Black or African American414747135
More than one race1113
Native Hawaiian or Other Pacific Islander0000
Unknown or Not Reported25411
White32202072
Region of Enrollment
Units: participants - Number
Participants Analyzed
767473223
United States767473223

Outcome Measures

1. Primary: Recurrent Infection

Measure Type
Primary
Measure Title
Recurrent Infection
Measure Description
Confirmed new MRSA infections
Time Frame
Within 6 months

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
These study participants who self-reported re-infections of MRSA

Reporting Groups

TitleDescription
Unsupervised Decolonization
Mupirocin topical to nares twice daily x7 days; Chlorhexidine bath on Days 1 and 7
Supervised Decolonization
Mupirocin topical to nares twice daily x7 days; Chlorhexidine bath on Days 1 and 7 with daily call/text message reminders
No Intervention
No decolonization agents

Outcome Measures

Unsupervised DecolonizationSupervised DecolonizationNo Intervention
Participants Analyzed
Units: Participants
484952
Recurrent Infection
Units: participants - Number
131

2. Primary: First Two Consecutive Sampling Periods Completed

Measure Type
Primary
Measure Title
First Two Consecutive Sampling Periods Completed
Measure Description
Subjects who returned samples for at least the first two consecutive sampling periods were included in analysis
Time Frame
Within 2 months

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
These subjects sent in two consecutive swab samples starting with their first follow-up time point.

Reporting Groups

TitleDescription
Unsupervised Decolonization
Mupirocin topical to nares twice daily x7 days; Chlorhexidine bath on Days 1 and 7
Supervised Decolonization
Mupirocin topical to nares twice daily x7 days; Chlorhexidine bath on Days 1 and 7 with daily call/text message reminders
No Intervention
No decolonization agents

Outcome Measures

Unsupervised DecolonizationSupervised DecolonizationNo Intervention
Participants Analyzed
Units: Participants
484952
First Two Consecutive Sampling Periods Completed
Units: participants - Number
484952

3. Secondary: Time to Clearance of Methicillin-resistant Staphylococcus Aureus (MRSA) Colonization

Measure Type
Secondary
Measure Title
Time to Clearance of Methicillin-resistant Staphylococcus Aureus (MRSA) Colonization
Measure Description
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 Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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

Reporting Groups

TitleDescription
Unsupervised Decolonization
Mupirocin topical to nares twice daily x7 days; Chlorhexidine bath on Days 1 and 7
Supervised Decolonization
Mupirocin topical to nares twice daily x7 days; Chlorhexidine bath on Days 1 and 7 with daily call/text message reminders
No Intervention
No decolonization agents

Outcome Measures

Unsupervised DecolonizationSupervised DecolonizationNo Intervention
Participants Analyzed
Units: Participants
484952
Time to Clearance of Methicillin-resistant Staphylococcus Aureus (MRSA) Colonization
Units: days - Median (95% Confidence Interval)
232319

Serious Adverse Events

Time Frame
1 week
Additional Description
Serious adverse events include: Death Life threatening adverse experience Inpatient hospitalization/prolongation of existing hospitalization Persistent disability/incapacity Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.
Frequency Threshold0% (Threshold above which other adverse events are reported)

Reporting Groups

TitleDescription
Unsupervised Decolonization
Households undergo decolonization for MRSA. The intervention includes applying Mupirocin ointment twice daily 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. Unsupervised 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.
Supervised Decolonization
Households undergo decolonization for MRSA. Intervention includes applying Mupirocin ointment twice daily for the first 7 days of study enrollment AND using Hibliclens body wash twice total (day 1 and day 7 of study enrollment) according to the instructions provided. To ensure compliance, study staff is in contact with household members. Supervised Decolonization: Households will undergo decolonization for MRSA with Mupirocin nasal ointment and Hibiclens body wash. Intervention includes applying Mupirocin ointment twice daily in each nostril for the first 7 days of study enrollment AND using Hibliclens body wash twice total (day 1 and day 7 of study enrollment) according to the instructions provided. Households are asked to fill out logs tracking compliance for each household member. Study staff contacts households daily (phone/text) to ensure complicane, to provide reminders to household members to perform the decolonization protocol, and to answer study question/concerns.
No Intervention
Households do not undergo active MRSA decolonization protocol

Serious Adverse Events

Unsupervised DecolonizationSupervised DecolonizationNo Intervention
Total, serious adverse events
No. of participants affected / at risk5/76 (0.00%)7/74 (0.00%)4/73 (0.00%)
cancer
No. of participants affected / at risk0/76 (0.00%)1/74 (0.00%)0/73 (0.00%)
heart disease
No. of participants affected / at risk0/76 (0.00%)1/74 (0.00%)3/73 (0.00%)
hypertension
No. of participants affected / at risk2/76 (0.00%)0/74 (0.00%)0/73 (0.00%)
hemmorage
No. of participants affected / at risk0/76 (0.00%)0/74 (0.00%)1/73 (0.00%)
homocide
No. of participants affected / at risk0/76 (0.00%)1/74 (0.00%)0/73 (0.00%)
Anorexia nervosa
No. of participants affected / at risk2/76 (0.00%)0/74 (0.00%)0/73 (0.00%)
inflammatory bowel
No. of participants affected / at risk0/76 (0.00%)1/74 (0.00%)0/73 (0.00%)
cancer
No. of participants affected / at risk0/76 (0.00%)1/74 (0.00%)0/73 (0.00%)
abscess
No. of participants affected / at risk0/76 (0.00%)3/74 (0.00%)0/73 (0.00%)

Other Adverse Events

Time Frame
1 week
Additional Description
Serious adverse events include: Death Life threatening adverse experience Inpatient hospitalization/prolongation of existing hospitalization Persistent disability/incapacity Medical event (may not be life threatening/require immediate hospitalization) but may require medical/surgical intervention to prevent a serious adverse event.
Frequency Threshold0% (Threshold above which other adverse events are reported)

Reporting Groups

TitleDescription
Unsupervised Decolonization
Households undergo decolonization for MRSA. The intervention includes applying Mupirocin ointment twice daily 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. Unsupervised 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.
Supervised Decolonization
Households undergo decolonization for MRSA. Intervention includes applying Mupirocin ointment twice daily for the first 7 days of study enrollment AND using Hibliclens body wash twice total (day 1 and day 7 of study enrollment) according to the instructions provided. To ensure compliance, study staff is in contact with household members. Supervised Decolonization: Households will undergo decolonization for MRSA with Mupirocin nasal ointment and Hibiclens body wash. Intervention includes applying Mupirocin ointment twice daily in each nostril for the first 7 days of study enrollment AND using Hibliclens body wash twice total (day 1 and day 7 of study enrollment) according to the instructions provided. Households are asked to fill out logs tracking compliance for each household member. Study staff contacts households daily (phone/text) to ensure complicane, to provide reminders to household members to perform the decolonization protocol, and to answer study question/concerns.
No Intervention
Households do not undergo active MRSA decolonization protocol

Other Adverse Events

Unsupervised DecolonizationSupervised DecolonizationNo Intervention
Total, other adverse events
No. of participants affected / at risk17/76 (0.00%)29/74 (0.00%)0/73 (0.00%)
runny nose
No. of participants affected / at risk4/76 (0.00%)3/74 (0.00%)0/73 (0.00%)
feel sick
No. of participants affected / at risk1/76 (0.00%)4/74 (0.00%)0/73 (0.00%)
nasal congestion
No. of participants affected / at risk0/76 (0.00%)6/74 (0.00%)0/73 (0.00%)
headache
No. of participants affected / at risk1/76 (0.00%)0/74 (0.00%)0/73 (0.00%)
sore throat
No. of participants affected / at risk0/76 (0.00%)2/74 (0.00%)0/73 (0.00%)
common cold
No. of participants affected / at risk1/76 (0.00%)0/74 (0.00%)0/73 (0.00%)
sneezing
No. of participants affected / at risk0/76 (0.00%)1/74 (0.00%)0/73 (0.00%)
abscess
No. of participants affected / at risk0/76 (0.00%)1/74 (0.00%)0/73 (0.00%)
fever
No. of participants affected / at risk5/76 (0.00%)1/74 (0.00%)0/73 (0.00%)
flu
No. of participants affected / at risk3/76 (0.00%)0/74 (0.00%)0/73 (0.00%)
Broken bone
No. of participants affected / at risk1/76 (0.00%)0/74 (0.00%)0/73 (0.00%)
burning
No. of participants affected / at risk0/76 (0.00%)3/74 (0.00%)0/73 (0.00%)
itching
No. of participants affected / at risk0/76 (0.00%)3/74 (0.00%)0/73 (0.00%)
irritation
No. of participants affected / at risk0/76 (0.00%)2/74 (0.00%)0/73 (0.00%)
rash
No. of participants affected / at risk1/76 (0.00%)0/74 (0.00%)0/73 (0.00%)
dry skin
No. of participants affected / at risk0/76 (0.00%)3/74 (0.00%)0/73 (0.00%)

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/TitleOrganizationPhoneEmail
Ebbing Lautenbach, MD, MPH, MSCE
Perelman School of Medicine, University of Pennsylvania
215-898-6977