Trial Outcomes & Findings for Staphylococcus Aureus Decolonization Study (NCT NCT00731783)

NCT ID: NCT00731783

Last Updated: 2012-04-30

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 183 participants
• Primary outcome timeframe: 1 month after enrollment.
• Results posted on: 2012-04-30

Participant Flow

Participant milestones

Measure	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.
One Month Follow-Up Visit STARTED	92	91
One Month Follow-Up Visit COMPLETED	78	69
One Month Follow-Up Visit NOT COMPLETED	14	22
Three Month Follow-Up Visit STARTED	79	73
Three Month Follow-Up Visit COMPLETED	72	57
Three Month Follow-Up Visit NOT COMPLETED	7	16
Six Month Follow-Up Visit STARTED	77	67
Six Month Follow-Up Visit COMPLETED	71	64
Six Month Follow-Up Visit NOT COMPLETED	6	3
12 Month Follow-Up Visit STARTED	74	65
12 Month Follow-Up Visit COMPLETED	68	58
12 Month Follow-Up Visit NOT COMPLETED	6	7

Reasons for withdrawal

Measure	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.
One Month Follow-Up Visit Lost to Follow-up	14	22
Three Month Follow-Up Visit Lost to Follow-up	7	16
Six Month Follow-Up Visit Lost to Follow-up	6	3
12 Month Follow-Up Visit Lost to Follow-up	6	7

Baseline Characteristics

Staphylococcus Aureus Decolonization Study

Baseline characteristics by cohort

Measure	Index Patient Only n=92 Participants Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.	Household n=91 Participants All members of the household (over the age of 6 months) will be asked to follow the study protocol.	Total n=183 Participants Total of all reporting groups
Age Continuous	6.3 Years STANDARD_DEVIATION 5.7 • n=5 Participants	5.7 Years STANDARD_DEVIATION 6.0 • n=7 Participants	6.0 Years STANDARD_DEVIATION 5.8 • n=5 Participants
Sex: Female, Male Female	55 Participants n=5 Participants	51 Participants n=7 Participants	106 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants	40 Participants n=7 Participants	77 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 month after enrollment.

Population: Modified intention to treat analysis

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.

Outcome measures

Measure	Index Patient Only n=78 Participants Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.	Household n=69 Participants All members of the household (over the age of 6 months) will be asked to follow the study protocol.
Number of Index Patients Eradicated of S. Aureus Carriage - 1 Month After Performing Decolonization Measures	39 Participants	35 Participants

SECONDARY outcome

Timeframe: 3 month after enrollment.

Population: Modified intention to treat analysis

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.

Outcome measures

Measure	Index Patient Only n=72 Participants Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.	Household n=57 Participants All members of the household (over the age of 6 months) will be asked to follow the study protocol.
Number of Index Patients Eradicated of S. Aureus Carriage - 3 Month After Performing Decolonization Measures	39 Participants	41 Participants

SECONDARY outcome

Timeframe: 6 month after enrollment.

Population: Modified intention to treat analysis

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.

Outcome measures

Measure	Index Patient Only n=71 Participants Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.	Household n=64 Participants All members of the household (over the age of 6 months) will be asked to follow the study protocol.
Number of Index Patients Eradicated of S. Aureus Carriage - 6 Month After Performing Decolonization Measures	39 Participants	31 Participants

SECONDARY outcome

Timeframe: 12 month after enrollment.

Population: Modified intention to treat analysis

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.

Outcome measures

Measure	Index Patient Only n=68 Participants Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.	Household n=58 Participants All members of the household (over the age of 6 months) will be asked to follow the study protocol.
Number of Index Patients Eradicated of S. Aureus Carriage - 12 Month After Performing Decolonization Measures	37 Participants	38 Participants

SECONDARY outcome

Timeframe: 1 month after enrollment

Population: Modified intention to treat analysis

Recurrence of CA-MRSA Skin or Soft Tissue Infection

Outcome measures

Measure	Index Patient Only n=81 Participants Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.	Household n=72 Participants All members of the household (over the age of 6 months) will be asked to follow the study protocol.
Recurrence of CA-MRSA Skin or Soft Tissue Infection - 1 Month After Enrollment.	21 Participants	11 Participants

SECONDARY outcome

Timeframe: 3 month after enrollment

Population: Modified intention to treat analysis

Recurrence of CA-MRSA Skin or Soft Tissue Infection

Outcome measures

Measure	Index Patient Only n=76 Participants Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.	Household n=69 Participants All members of the household (over the age of 6 months) will be asked to follow the study protocol.
Recurrence of CA-MRSA Skin or Soft Tissue Infection - 3 Month After Enrollment.	36 Participants	19 Participants

SECONDARY outcome

Timeframe: 6 month after enrollment

Population: Modified intention to treat analysis

Recurrence of CA-MRSA Skin or Soft Tissue Infection

Outcome measures

Measure	Index Patient Only n=76 Participants Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.	Household n=69 Participants All members of the household (over the age of 6 months) will be asked to follow the study protocol.
Recurrence of CA-MRSA Skin or Soft Tissue Infection - 6 Month After Enrollment.	46 Participants	26 Participants

SECONDARY outcome

Timeframe: 12 month after enrollment

Population: Modified intention to treat analysis

Recurrence of CA-MRSA Skin or Soft Tissue Infection

Outcome measures

Measure	Index Patient Only n=78 Participants Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.	Household n=65 Participants All members of the household (over the age of 6 months) will be asked to follow the study protocol.
Recurrence of CA-MRSA Skin or Soft Tissue Infection - 12 Month After Enrollment.	56 Participants	34 Participants

Adverse Events

Index Patient Only

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Household

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Index Patient Only n=85 participants at risk Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.	Household n=77 participants at risk All members of the household (over the age of 6 months) will be asked to follow the study protocol.
Skin and subcutaneous tissue disorders Dry Skin	11.8% 10/85 • 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. 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).	16.9% 13/77 • 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. 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).
Skin and subcutaneous tissue disorders Rash	5.9% 5/85 • 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. 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).	5.2% 4/77 • 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. 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).

Additional Information

Stephanie A. Fritz, M.D., M.S.C.I.

Washington University

Phone: 314-454-6050

Email: fritz_s@kids.wustl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place