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Trial record 12 of 17 for:    "Connective Tissue Disease" | "Ethanol"

Staphylococcus Aureus Decolonization Study (SuDS)

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ClinicalTrials.gov Identifier: NCT00731783
Recruitment Status : Completed
First Posted : August 11, 2008
Results First Posted : March 23, 2011
Last Update Posted : April 30, 2012
Sponsor:
Information provided by (Responsible Party):
Stephanie A. Fritz, Washington University School of Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Staphylococcal Skin Infections
Abscesses
Furunculosis
Staphylococcus Aureus
MRSA Infection
Interventions Drug: 2% Mupirocin Ointment
Drug: 4% Chlorhexidine liquid soap
Behavioral: Hygiene protocol
Enrollment 183
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Index Patient Only Household
Hide Arm/Group Description Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen, which includes application of 2% Mupirocin Ointment to the anterior nares twice daily for 5 days and washing with 4% Chlorhexidine liquid soap daily for 5 days. All members of the household (over the age of 6 months) will be asked to follow the study protocol, which includes application of 2% Mupirocin Ointment to the anterior nares twice daily for 5 days and washing with 4% Chlorhexidine liquid soap daily for 5 days.
Period Title: One Month Follow-Up Visit
Started 92 91
Completed 78 69
Not Completed 14 22
Reason Not Completed
Lost to Follow-up             14             22
Period Title: Three Month Follow-Up Visit
Started 79 73
Completed 72 57
Not Completed 7 16
Reason Not Completed
Lost to Follow-up             7             16
Period Title: Six Month Follow-Up Visit
Started 77 67
Completed 71 64
Not Completed 6 3
Reason Not Completed
Lost to Follow-up             6             3
Period Title: 12 Month Follow-Up Visit
Started 74 65
Completed 68 58
Not Completed 6 7
Reason Not Completed
Lost to Follow-up             6             7
Arm/Group Title Index Patient Only Household Total
Hide Arm/Group Description Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen. All members of the household (over the age of 6 months) will be asked to follow the study protocol. Total of all reporting groups
Overall Number of Baseline Participants 92 91 183
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 92 participants 91 participants 183 participants
6.3  (5.7) 5.7  (6.0) 6.0  (5.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 participants 91 participants 183 participants
Female
55
  59.8%
51
  56.0%
106
  57.9%
Male
37
  40.2%
40
  44.0%
77
  42.1%
1.Primary Outcome
Title Number of Index Patients Eradicated of S. Aureus Carriage - 1 Month After Performing Decolonization Measures
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intention to treat analysis
Arm/Group Title Index Patient Only Household
Hide Arm/Group Description:
Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.
All members of the household (over the age of 6 months) will be asked to follow the study protocol.
Overall Number of Participants Analyzed 78 69
Measure Type: Number
Unit of Measure: Participants
39 35
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Index Patient Only, Household
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.03
Confidence Interval (2-Sided) 95%
0.54 to 1.97
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Index Patients Eradicated of S. Aureus Carriage - 3 Month After Performing Decolonization Measures
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intention to treat analysis
Arm/Group Title Index Patient Only Household
Hide Arm/Group Description:
Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.
All members of the household (over the age of 6 months) will be asked to follow the study protocol.
Overall Number of Participants Analyzed 72 57
Measure Type: Number
Unit of Measure: Participants
39 41
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Index Patient Only, Household
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.17
Confidence Interval (2-Sided) 95%
1.03 to 4.55
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Index Patients Eradicated of S. Aureus Carriage - 6 Month After Performing Decolonization Measures
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intention to treat analysis
Arm/Group Title Index Patient Only Household
Hide Arm/Group Description:
Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.
All members of the household (over the age of 6 months) will be asked to follow the study protocol.
Overall Number of Participants Analyzed 71 64
Measure Type: Number
Unit of Measure: Participants
39 31
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Index Patient Only, Household
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.49
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.77
Confidence Interval (2-Sided) 95%
0.39 to 1.52
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Number of Index Patients Eradicated of S. Aureus Carriage - 12 Month After Performing Decolonization Measures
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intention to treat analysis
Arm/Group Title Index Patient Only Household
Hide Arm/Group Description:
Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.
All members of the household (over the age of 6 months) will be asked to follow the study protocol.
Overall Number of Participants Analyzed 68 58
Measure Type: Number
Unit of Measure: Participants
37 38
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Index Patient Only, Household
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.28
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.59
Confidence Interval (2-Sided) 95%
0.77 to 3.28
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Recurrence of CA-MRSA Skin or Soft Tissue Infection - 1 Month After Enrollment.
Hide Description Recurrence of CA-MRSA Skin or Soft Tissue Infection
Time Frame 1 month after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intention to treat analysis
Arm/Group Title Index Patient Only Household
Hide Arm/Group Description:
Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.
All members of the household (over the age of 6 months) will be asked to follow the study protocol.
Overall Number of Participants Analyzed 81 72
Measure Type: Number
Unit of Measure: Participants
21 11
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Index Patient Only, Household
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.12
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.52
Confidence Interval (2-Sided) 95%
0.23 to 1.16
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Recurrence of CA-MRSA Skin or Soft Tissue Infection - 3 Month After Enrollment.
Hide Description Recurrence of CA-MRSA Skin or Soft Tissue Infection
Time Frame 3 month after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intention to treat analysis
Arm/Group Title Index Patient Only Household
Hide Arm/Group Description:
Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.
All members of the household (over the age of 6 months) will be asked to follow the study protocol.
Overall Number of Participants Analyzed 76 69
Measure Type: Number
Unit of Measure: Participants
36 19
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Index Patient Only, Household
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.42
Confidence Interval (2-Sided) 95%
0.21 to 0.85
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Recurrence of CA-MRSA Skin or Soft Tissue Infection - 6 Month After Enrollment.
Hide Description Recurrence of CA-MRSA Skin or Soft Tissue Infection
Time Frame 6 month after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intention to treat analysis
Arm/Group Title Index Patient Only Household
Hide Arm/Group Description:
Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.
All members of the household (over the age of 6 months) will be asked to follow the study protocol.
Overall Number of Participants Analyzed 76 69
Measure Type: Number
Unit of Measure: Participants
46 26
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Index Patient Only, Household
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.39
Confidence Interval (2-Sided) 95%
0.20 to 0.77
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Recurrence of CA-MRSA Skin or Soft Tissue Infection - 12 Month After Enrollment.
Hide Description Recurrence of CA-MRSA Skin or Soft Tissue Infection
Time Frame 12 month after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intention to treat analysis
Arm/Group Title Index Patient Only Household
Hide Arm/Group Description:
Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.
All members of the household (over the age of 6 months) will be asked to follow the study protocol.
Overall Number of Participants Analyzed 78 65
Measure Type: Number
Unit of Measure: Participants
56 34
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Index Patient Only, Household
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.43
Confidence Interval (2-Sided) 95%
0.22 to 0.86
Estimation Comments [Not Specified]
Time Frame Adverse events were collected by phone approximately 7-10 days following study enrollment. The intervention only lasted 5 days and thus all adverse events would have happened by this time.
Adverse Event Reporting Description There are more participants with data on adverse events than data on the primary outcome measure because some participants completed the follow-up phone call at 7-10 days (where adverse events were assessed) but failed to complete the 1 month follow-up visit (where primary outcome measure was assessed).
 
Arm/Group Title Index Patient Only Household
Hide Arm/Group Description Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen. All members of the household (over the age of 6 months) will be asked to follow the study protocol.
All-Cause Mortality
Index Patient Only Household
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Index Patient Only Household
Affected / at Risk (%) Affected / at Risk (%)
Total   0/85 (0.00%)   0/77 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Index Patient Only Household
Affected / at Risk (%) Affected / at Risk (%)
Total   15/85 (17.65%)   17/77 (22.08%) 
Skin and subcutaneous tissue disorders     
Dry Skin  10/85 (11.76%)  13/77 (16.88%) 
Rash  5/85 (5.88%)  4/77 (5.19%) 
Certain Agreements
Principal Investigators are NOT 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/Title: Stephanie A. Fritz, M.D., M.S.C.I.
Organization: Washington University
Phone: 314-454-6050
Responsible Party: Stephanie A. Fritz, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00731783     History of Changes
Other Study ID Numbers: 3177 38145
First Submitted: August 7, 2008
First Posted: August 11, 2008
Results First Submitted: March 2, 2011
Results First Posted: March 23, 2011
Last Update Posted: April 30, 2012