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Staphylococcus Aureus Decolonization Study

Household vs. Individual Approach to Decolonization of Community-acquired Methicillin-resistant Staphylococcus Aureus.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00731783
Acronym
SuDS
Enrollment
183
Registered
2008-08-11
Start date
2008-07-31
Completion date
2010-12-31
Last updated
2012-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abscesses, Furunculosis, MRSA Infection, Staphylococcal Skin Infections, Staphylococcus Aureus

Keywords

Abscesses, Furunculosis, Staphylococcus aureus colonization, Staphylococcal Skin Infections, MRSA

Brief summary

The purpose of this study is to determine whether measures to eliminate the Staph germ from the skin of the index patient (with a special ointment and soap) are more effective when performed by everyone in the household rather than the patient alone, and whether these methods are effective in preventing future Staph infections. The investigators hypothesize that there will be a greater number of households who are successful in eradicating the staph germ from the index patient when all members of the household participate than households where only the index patient is treated.

Detailed description

Methicillin-resistant Staphylococcus aureus (MRSA) was once uniformly associated with hospital-acquired infections; however, MRSA strains have emerged that thrive outside the hospital environment, causing significant morbidity and mortality among immunocompetent individuals, leading to their designation as community-acquired methicillin resistant Staphylococcus aureus (CA-MRSA). CA-MRSA has become a major source of morbidity and mortality in our pediatric population. An important prerequisite for S. aureus infection may be nasal carriage of the organism. A variety of decolonization strategies have been used for infection prophylaxis, primarily in patients undergoing hemodialysis or surgery, with varying results. However, there are no published randomized eradication trials evaluating the decolonization and prevention of CA-MRSA infections in immunocompetent children in the outpatient setting. While the transmission of CA-MRSA within households has been reported, its contribution to recurrent CA-MRSA infection among household members is undetermined. The investigators hypothesize that spread of CA-MRSA among household members leads to recolonization or failure of decolonization in children undergoing eradication efforts. Specific Aim: In pediatric patients presenting with a MRSA skin or soft tissue infection, compare the effectiveness of decolonization measures performed by an entire household in comparison to measures directed at the index patient alone. The investigators will conduct a randomized, controlled trial to test the hypothesis that decolonization measures performed by the entire household, specifically application of intranasal mupirocin ointment and bathing with chlorhexidine liquid soap, in addition to education and basic hygiene interventions, will be twice as effective in eradicating CA-MRSA carriage in the index patient than if the measures are performed only by the index patient.

Interventions

Apply ointment to the anterior nares twice daily for 5 days.

DRUG4% Chlorhexidine liquid soap

Bathe with liquid soap daily for 5 days.

Follow key hygiene tips indefinitely. Tips are: * Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles. * Use liquid(pour or pump) soaps instead of bar soaps. * Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell. * Do not share personal care items such as razors and brushes. * Wash all sheets and towels in hot water. Wash sheets every week. * Use towels and wash cloths only once before washing and do not share.

Sponsors

Washington University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Months to 21 Years
Healthy volunteers
No

Inclusion criteria

Screening: * Children aged 6 months to 21 years presenting with an active skin or soft tissue infection. Enrollment: * Positive MRSA culture from the abscess and from either the axilla, anterior nares or groin area (signifying both infection and colonization with MRSA).

Exclusion criteria

* Infants less than 6 months of age * Dialysis or residence in a long term care facility over the past year * Use of chlorhexidine or mupirocin in the past one month * Pregnancy * Immunodeficiency * History of an adverse reaction to chlorhexidine or mupirocin.

Design outcomes

Primary

MeasureTime frameDescription
Number of Index Patients Eradicated of S. Aureus Carriage - 1 Month After Performing Decolonization Measures1 month after enrollment.Eradication is defined as the absence of S. aureus carriage at the 3 sampled body sites (anterior nares, axilla, inguinal folds) of the index patient.

Secondary

MeasureTime frameDescription
Number of Index Patients Eradicated of S. Aureus Carriage - 3 Month After Performing Decolonization Measures3 month after enrollment.Eradication is defined as the absence of S. aureus carriage at the 3 sampled body sites (anterior nares, axilla, inguinal folds) of the index patient.
Number of Index Patients Eradicated of S. Aureus Carriage - 6 Month After Performing Decolonization Measures6 month after enrollment.Eradication is defined as the absence of S. aureus carriage at the 3 sampled body sites (anterior nares, axilla, inguinal folds) of the index patient.
Number of Index Patients Eradicated of S. Aureus Carriage - 12 Month After Performing Decolonization Measures12 month after enrollment.Eradication is defined as the absence of S. aureus carriage at the 3 sampled body sites (anterior nares, axilla, inguinal folds) of the index patient.
Recurrence of CA-MRSA Skin or Soft Tissue Infection - 1 Month After Enrollment.1 month after enrollmentRecurrence of CA-MRSA Skin or Soft Tissue Infection
Recurrence of CA-MRSA Skin or Soft Tissue Infection - 3 Month After Enrollment.3 month after enrollmentRecurrence of CA-MRSA Skin or Soft Tissue Infection
Recurrence of CA-MRSA Skin or Soft Tissue Infection - 6 Month After Enrollment.6 month after enrollmentRecurrence of CA-MRSA Skin or Soft Tissue Infection
Recurrence of CA-MRSA Skin or Soft Tissue Infection - 12 Month After Enrollment.12 month after enrollmentRecurrence of CA-MRSA Skin or Soft Tissue Infection

Countries

United States

Participant flow

Participants by arm

ArmCount
Index Patient Only
Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.
92
Household
All members of the household (over the age of 6 months) will be asked to follow the study protocol.
91
Total183

Withdrawals & dropouts

PeriodReasonFG000FG001
12 Month Follow-Up VisitLost to Follow-up67
One Month Follow-Up VisitLost to Follow-up1422
Six Month Follow-Up VisitLost to Follow-up63
Three Month Follow-Up VisitLost to Follow-up716

Baseline characteristics

CharacteristicTotalIndex Patient OnlyHousehold
Age Continuous6.0 Years
STANDARD_DEVIATION 5.8
6.3 Years
STANDARD_DEVIATION 5.7
5.7 Years
STANDARD_DEVIATION 6
Sex: Female, Male
Female
106 Participants55 Participants51 Participants
Sex: Female, Male
Male
77 Participants37 Participants40 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
15 / 8517 / 77
serious
Total, serious adverse events
0 / 850 / 77

Outcome results

Primary

Number of Index Patients Eradicated of S. Aureus Carriage - 1 Month After Performing Decolonization Measures

Eradication is defined as the absence of S. aureus carriage at the 3 sampled body sites (anterior nares, axilla, inguinal folds) of the index patient.

Time frame: 1 month after enrollment.

Population: Modified intention to treat analysis

ArmMeasureValue (NUMBER)
Index Patient OnlyNumber of Index Patients Eradicated of S. Aureus Carriage - 1 Month After Performing Decolonization Measures39 Participants
HouseholdNumber of Index Patients Eradicated of S. Aureus Carriage - 1 Month After Performing Decolonization Measures35 Participants
p-value: 195% CI: [0.54, 1.97]Fisher Exact
Secondary

Number of Index Patients Eradicated of S. Aureus Carriage - 12 Month After Performing Decolonization Measures

Eradication is defined as the absence of S. aureus carriage at the 3 sampled body sites (anterior nares, axilla, inguinal folds) of the index patient.

Time frame: 12 month after enrollment.

Population: Modified intention to treat analysis

ArmMeasureValue (NUMBER)
Index Patient OnlyNumber of Index Patients Eradicated of S. Aureus Carriage - 12 Month After Performing Decolonization Measures37 Participants
HouseholdNumber of Index Patients Eradicated of S. Aureus Carriage - 12 Month After Performing Decolonization Measures38 Participants
p-value: 0.2895% CI: [0.77, 3.28]Fisher Exact
Secondary

Number of Index Patients Eradicated of S. Aureus Carriage - 3 Month After Performing Decolonization Measures

Eradication is defined as the absence of S. aureus carriage at the 3 sampled body sites (anterior nares, axilla, inguinal folds) of the index patient.

Time frame: 3 month after enrollment.

Population: Modified intention to treat analysis

ArmMeasureValue (NUMBER)
Index Patient OnlyNumber of Index Patients Eradicated of S. Aureus Carriage - 3 Month After Performing Decolonization Measures39 Participants
HouseholdNumber of Index Patients Eradicated of S. Aureus Carriage - 3 Month After Performing Decolonization Measures41 Participants
p-value: 0.0595% CI: [1.03, 4.55]Fisher Exact
Secondary

Number of Index Patients Eradicated of S. Aureus Carriage - 6 Month After Performing Decolonization Measures

Eradication is defined as the absence of S. aureus carriage at the 3 sampled body sites (anterior nares, axilla, inguinal folds) of the index patient.

Time frame: 6 month after enrollment.

Population: Modified intention to treat analysis

ArmMeasureValue (NUMBER)
Index Patient OnlyNumber of Index Patients Eradicated of S. Aureus Carriage - 6 Month After Performing Decolonization Measures39 Participants
HouseholdNumber of Index Patients Eradicated of S. Aureus Carriage - 6 Month After Performing Decolonization Measures31 Participants
p-value: 0.4995% CI: [0.39, 1.52]Fisher Exact
Secondary

Recurrence of CA-MRSA Skin or Soft Tissue Infection - 12 Month After Enrollment.

Recurrence of CA-MRSA Skin or Soft Tissue Infection

Time frame: 12 month after enrollment

Population: Modified intention to treat analysis

ArmMeasureValue (NUMBER)
Index Patient OnlyRecurrence of CA-MRSA Skin or Soft Tissue Infection - 12 Month After Enrollment.56 Participants
HouseholdRecurrence of CA-MRSA Skin or Soft Tissue Infection - 12 Month After Enrollment.34 Participants
p-value: 0.0295% CI: [0.22, 0.86]Fisher Exact
Secondary

Recurrence of CA-MRSA Skin or Soft Tissue Infection - 1 Month After Enrollment.

Recurrence of CA-MRSA Skin or Soft Tissue Infection

Time frame: 1 month after enrollment

Population: Modified intention to treat analysis

ArmMeasureValue (NUMBER)
Index Patient OnlyRecurrence of CA-MRSA Skin or Soft Tissue Infection - 1 Month After Enrollment.21 Participants
HouseholdRecurrence of CA-MRSA Skin or Soft Tissue Infection - 1 Month After Enrollment.11 Participants
p-value: 0.1295% CI: [0.23, 1.16]Fisher Exact
Secondary

Recurrence of CA-MRSA Skin or Soft Tissue Infection - 3 Month After Enrollment.

Recurrence of CA-MRSA Skin or Soft Tissue Infection

Time frame: 3 month after enrollment

Population: Modified intention to treat analysis

ArmMeasureValue (NUMBER)
Index Patient OnlyRecurrence of CA-MRSA Skin or Soft Tissue Infection - 3 Month After Enrollment.36 Participants
HouseholdRecurrence of CA-MRSA Skin or Soft Tissue Infection - 3 Month After Enrollment.19 Participants
p-value: 0.0295% CI: [0.21, 0.85]Fisher Exact
Secondary

Recurrence of CA-MRSA Skin or Soft Tissue Infection - 6 Month After Enrollment.

Recurrence of CA-MRSA Skin or Soft Tissue Infection

Time frame: 6 month after enrollment

Population: Modified intention to treat analysis

ArmMeasureValue (NUMBER)
Index Patient OnlyRecurrence of CA-MRSA Skin or Soft Tissue Infection - 6 Month After Enrollment.46 Participants
HouseholdRecurrence of CA-MRSA Skin or Soft Tissue Infection - 6 Month After Enrollment.26 Participants
p-value: 0.00895% CI: [0.2, 0.77]Fisher Exact

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026