Trial Outcomes & Findings for The Natural History of Community-Associated MRSA Infections and Decolonization Strategies (NCT NCT00513799)
NCT ID: NCT00513799
Last Updated: 2015-07-30
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. Samples obtained by study team at follow-up visit.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
300 participants
Primary outcome timeframe
1 month follow-up
Results posted on
2015-07-30
Participant Flow
Participant milestones
| Measure |
Hygiene Education
Participants only administered an intensive education on prevention of skin infections through improvements in personal hygiene (also serves as "control group")
|
Hygiene Education + Mupirocin
Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days
|
Education + Mupirocin + Chlorhexidine
Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days AND prescribed Chlorhexidine wash to entire body once daily for 5 days.
|
Education + Mupirocin + Bleach Baths
Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days AND prescribed bleach bath to entire body once daily for 5 days (instructed to pour 2 ounces of bleach into water-filled bath tub and soak in bath for 15 minutes).
|
|---|---|---|---|---|
|
One-Month Follow-Up
STARTED
|
75
|
75
|
75
|
75
|
|
One-Month Follow-Up
COMPLETED
|
64
|
62
|
64
|
54
|
|
One-Month Follow-Up
NOT COMPLETED
|
11
|
13
|
11
|
21
|
|
Four-Month Follow-Up
STARTED
|
64
|
62
|
64
|
54
|
|
Four-Month Follow-Up
COMPLETED
|
64
|
57
|
57
|
51
|
|
Four-Month Follow-Up
NOT COMPLETED
|
0
|
5
|
7
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Natural History of Community-Associated MRSA Infections and Decolonization Strategies
Baseline characteristics by cohort
| Measure |
Hygiene Education
n=75 Participants
Participants only administered an intensive education on prevention of skin infections through improvements in personal hygiene (also serves as "control group")
|
Hygiene Education + Mupirocin
n=75 Participants
Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days
|
Education + Mupirocin + Chlorhexidine
n=75 Participants
Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days AND prescribed Chlorhexidine wash to entire body once daily for 5 days.
|
Education + Mupirocin + Bleach Baths
n=75 Participants
Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days AND prescribed bleach bath to entire body once daily for 5 days (instructed to pour 2 ounces of bleach into water-filled bath tub and soak in bath for 15 minutes).
|
Total
n=300 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
17.37 years
STANDARD_DEVIATION 16.57 • n=5 Participants
|
16.52 years
STANDARD_DEVIATION 16.12 • n=7 Participants
|
18.19 years
STANDARD_DEVIATION 17.37 • n=5 Participants
|
18.67 years
STANDARD_DEVIATION 15.29 • n=4 Participants
|
17.61 years
STANDARD_DEVIATION 16.31 • n=21 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
161 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
139 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 1 month follow-upEradication is defined as the absence of S. aureus carriage at the 3 sampled body sites (anterior nares, axilla, inguinal folds) of the index patient. Samples obtained by study team at follow-up visit.
Outcome measures
| Measure |
Hygiene Education
n=64 Participants
Participants only administered an intensive education on prevention of skin infections through improvements in personal hygiene (also serves as "control group")
|
Hygiene Education + Mupirocin
n=62 Participants
Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days
|
Education + Mupirocin + Chlorhexidine
n=64 Participants
Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days AND prescribed Chlorhexidine wash to entire body once daily for 5 days.
|
Education + Mupirocin + Bleach Baths
n=54 Participants
Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days AND prescribed bleach bath to entire body once daily for 5 days (instructed to pour 2 ounces of bleach into water-filled bath tub and soak in bath for 15 minutes).
|
|---|---|---|---|---|
|
Number of Participants Eradicated of S. Aureus Carriage - 1 Month After Intervention
|
24 Participants
|
35 Participants
|
35 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: 1, 4 and 6 month follow-upsPopulation: Groups 1/4 have 1 more participant analyzed each than in participant flow module due to data collected by phone. They did not return to hospital for followup (colonization swabs were not obtained). Group 3 has 1 less participant analyzed than in participant flow module due to missing data point on followup survey. They were not able to be reached.
Recurrent Staphylococcus aureus Skin or Soft Tissue Infection is defined as incidence of skin abscess, impetigo, cellulitis, or spider bite in the 1 month following intervention. Infections reported by participant at follow-up visit.
Outcome measures
| Measure |
Hygiene Education
n=65 Participants
Participants only administered an intensive education on prevention of skin infections through improvements in personal hygiene (also serves as "control group")
|
Hygiene Education + Mupirocin
n=62 Participants
Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days
|
Education + Mupirocin + Chlorhexidine
n=63 Participants
Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days AND prescribed Chlorhexidine wash to entire body once daily for 5 days.
|
Education + Mupirocin + Bleach Baths
n=55 Participants
Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days AND prescribed bleach bath to entire body once daily for 5 days (instructed to pour 2 ounces of bleach into water-filled bath tub and soak in bath for 15 minutes).
|
|---|---|---|---|---|
|
Number of Participants With Recurrent Staphylococcus Aureus Skin or Soft Tissue Infection
1 Month Follow-up
|
17 Participants
|
14 Participants
|
7 Participants
|
12 Participants
|
|
Number of Participants With Recurrent Staphylococcus Aureus Skin or Soft Tissue Infection
4 Month Follow-up
|
26 Participants
|
20 Participants
|
19 Participants
|
18 Participants
|
|
Number of Participants With Recurrent Staphylococcus Aureus Skin or Soft Tissue Infection
6 Month Follow-up
|
28 Participants
|
27 Participants
|
23 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: 4 month follow-upEradication is defined as the absence of S. aureus carriage at the 3 sampled body sites (anterior nares, axilla, inguinal folds) of the index patient. Samples obtained by study team at follow-up visit.
Outcome measures
| Measure |
Hygiene Education
n=64 Participants
Participants only administered an intensive education on prevention of skin infections through improvements in personal hygiene (also serves as "control group")
|
Hygiene Education + Mupirocin
n=57 Participants
Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days
|
Education + Mupirocin + Chlorhexidine
n=57 Participants
Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days AND prescribed Chlorhexidine wash to entire body once daily for 5 days.
|
Education + Mupirocin + Bleach Baths
n=51 Participants
Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days AND prescribed bleach bath to entire body once daily for 5 days (instructed to pour 2 ounces of bleach into water-filled bath tub and soak in bath for 15 minutes).
|
|---|---|---|---|---|
|
Number of Participants Eradicated of S. Aureus Carriage - 4 Months After Intervention
|
31 Participants
|
32 Participants
|
31 Participants
|
36 Participants
|
Adverse Events
Hygiene Education
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Hygiene Education + Mupirocin
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Education + Mupirocin + Chlorhexidine
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Education + Mupirocin + Bleach Baths
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Hygiene Education
n=72 participants at risk
Participants only administered an intensive education on prevention of skin infections through improvements in personal hygiene (also serves as "control group")
|
Hygiene Education + Mupirocin
n=72 participants at risk
Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days
|
Education + Mupirocin + Chlorhexidine
n=70 participants at risk
Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days AND prescribed Chlorhexidine wash to entire body once daily for 5 days.
|
Education + Mupirocin + Bleach Baths
n=68 participants at risk
Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days AND prescribed bleach bath to entire body once daily for 5 days (instructed to pour 2 ounces of bleach into water-filled bath tub and soak in bath for 15 minutes).
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.6%
4/72 • 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).
|
1.4%
1/72 • 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).
|
7.1%
5/70 • 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).
|
16.2%
11/68 • 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place