Staphylococcus Aureus Decolonization Study (SuDS)
This study has been completed.
Sponsor:
Washington University School of Medicine
Information provided by (Responsible Party):
Stephanie A. Fritz, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00731783
First received: August 7, 2008
Last updated: April 23, 2012
Last verified: April 2012
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Results First Received: March 2, 2011
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: 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 |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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| No text entered. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Index Patient Only | 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. |
| Household | 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. |
Participant Flow for 4 periods
Period 1: One Month Follow-Up Visit
| Index Patient Only | Household | |
|---|---|---|
| STARTED | 92 | 91 |
| COMPLETED | 78 | 69 |
| NOT COMPLETED | 14 | 22 |
| Lost to Follow-up | 14 | 22 |
Period 2: Three Month Follow-Up Visit
| Index Patient Only | Household | |
|---|---|---|
| STARTED | 79 | 73 |
| COMPLETED | 72 | 57 |
| NOT COMPLETED | 7 | 16 |
| Lost to Follow-up | 7 | 16 |
Period 3: Six Month Follow-Up Visit
| Index Patient Only | Household | |
|---|---|---|
| STARTED | 77 | 67 |
| COMPLETED | 71 | 64 |
| NOT COMPLETED | 6 | 3 |
| Lost to Follow-up | 6 | 3 |
Period 4: 12 Month Follow-Up Visit
| Index Patient Only | Household | |
|---|---|---|
| STARTED | 74 | 65 |
| COMPLETED | 68 | 58 |
| NOT COMPLETED | 6 | 7 |
| Lost to Follow-up | 6 | 7 |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| Index Patient Only | Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen. |
| Household | All members of the household (over the age of 6 months) will be asked to follow the study protocol. |
| Total | Total of all reporting groups |
Baseline Measures
| Index Patient Only | Household | Total | |
|---|---|---|---|
|
Number of Participants
[units: participants] |
92 | 91 | 183 |
|
Age
[units: Years] Mean ± Standard Deviation |
6.3 ± 5.7 | 5.7 ± 6.0 | 6.0 ± 5.8 |
|
Gender
[units: Participants] |
|||
| Female | 55 | 51 | 106 |
| Male | 37 | 40 | 77 |
Outcome Measures
| 1. Primary: | Number of Index Patients Eradicated of S. Aureus Carriage - 1 Month After Performing Decolonization Measures [ Time Frame: 1 month after enrollment. ] |
| 2. Secondary: | Number of Index Patients Eradicated of S. Aureus Carriage - 3 Month After Performing Decolonization Measures [ Time Frame: 3 month after enrollment. ] |
| 3. Secondary: | Number of Index Patients Eradicated of S. Aureus Carriage - 6 Month After Performing Decolonization Measures [ Time Frame: 6 month after enrollment. ] |
| 4. Secondary: | Number of Index Patients Eradicated of S. Aureus Carriage - 12 Month After Performing Decolonization Measures [ Time Frame: 12 month after enrollment. ] |
| 5. Secondary: | Recurrence of CA-MRSA Skin or Soft Tissue Infection - 1 Month After Enrollment. [ Time Frame: 1 month after enrollment ] |
| 6. Secondary: | Recurrence of CA-MRSA Skin or Soft Tissue Infection - 3 Month After Enrollment. [ Time Frame: 3 month after enrollment ] |
| 7. Secondary: | Recurrence of CA-MRSA Skin or Soft Tissue Infection - 6 Month After Enrollment. [ Time Frame: 6 month after enrollment ] |
| 8. Secondary: | Recurrence of CA-MRSA Skin or Soft Tissue Infection - 12 Month After Enrollment. [ Time Frame: 12 month after enrollment ] |
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided by Washington University School of Medicine
Publications automatically indexed to this study:
| 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. |
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
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| No text entered. |
Results Point of Contact:
Name/Title: Stephanie A. Fritz, M.D., M.S.C.I.
Organization: Washington University
phone: 314-454-6050
e-mail: fritz_s@kids.wustl.edu
Organization: Washington University
phone: 314-454-6050
e-mail: fritz_s@kids.wustl.edu
No publications provided by Washington University School of Medicine
Publications automatically indexed to this study:
| Responsible Party: | Stephanie A. Fritz, Washington University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00731783 History of Changes |
| Other Study ID Numbers: | 3177 38145 |
| Study First Received: | August 7, 2008 |
| Results First Received: | March 2, 2011 |
| Last Updated: | April 23, 2012 |
| Health Authority: | United States: Institutional Review Board |