Trial Outcomes & Findings for Prevention of Recurrent Infections Caused by Community Acquired Staphylococcus Aureus (CA-SA) in Children (NCT NCT00901316)
NCT ID: NCT00901316
Last Updated: 2016-11-07
Results Overview
Medically attended skin and soft tissue infections (MA-SSI) which is defined as a skin or soft tissue infection that has been evaluated and treated by a medical professional in an office, clinic, urgent care or emergency center setting.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
987 participants
Primary outcome timeframe
From time of enrollment until the first MA-SSI or 12 months following enrollment, whichever came first.
Results posted on
2016-11-07
Participant Flow
Children with probable community-associated Staphylococcus aureus skin and soft tissue or invasive infections were randomized to routine daily hygienic measures with or without "bleach baths" twice a week for 3 months.
Participant milestones
| Measure |
Routine Measures
Routine Measures Group: Cultures will be obtained from the anterior nares of the nose, the throat and the groin using separate culturette swabs. S. aureus isolates will be identified and antibiotic susceptibility determined. Isolates will subsequently undergo testing for susceptibility to methicillin to determine if the isolate is an MSSA or MRSA strain. All patients and parents will be instructed orally and provided written instructions about routine measures employed for the prevention of S. aureus skin infections.
|
Bleach Baths
Bleach Bath Group: Cultures will be obtained from the anterior nares of the nose, the throat and the groin using culturette swabs. S. aureus isolates will be identified and antibiotic susceptibility determined. Isolates will subsequently undergo testing for susceptibility to methicillin to determine if the isolate is an MSSA or MRSA strain. Patients and parents will be instructed orally and provided written instructions about routine measures employed for the prevention of S. aureus skin infections. Patients will be given further oral and written instructions regarding clorox baths.
|
|---|---|---|
|
Overall Study
STARTED
|
492
|
495
|
|
Overall Study
COMPLETED
|
492
|
495
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prevention of Recurrent Infections Caused by Community Acquired Staphylococcus Aureus (CA-SA) in Children
Baseline characteristics by cohort
| Measure |
Routine Measures
n=492 Participants
Routine Measures Group: Cultures will be obtained from the anterior nares of the nose, the throat and the groin using separate culturette swabs. S. aureus isolates will be identified and antibiotic susceptibility determined. Isolates will subsequently undergo testing for susceptibility to methicillin to determine if the isolate is an MSSA or MRSA strain. All patients and parents will be instructed orally and provided written instructions about routine measures employed for the prevention of S. aureus skin infections.
|
Bleach Baths
n=495 Participants
Bleach Bath Group: Cultures will be obtained from the anterior nares of the nose, the throat and the groin using culturette swabs. S. aureus isolates will be identified and antibiotic susceptibility determined. Isolates will subsequently undergo testing for susceptibility to methicillin to determine if the isolate is an MSSA or MRSA strain. Patients and parents will be instructed orally and provided written instructions about routine measures employed for the prevention of S. aureus skin infections. Patients will be given further oral and written instructions regarding clorox baths.
|
Total
n=987 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
492 Participants
n=5 Participants
|
495 Participants
n=7 Participants
|
987 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
1.92 years
n=5 Participants
|
1.8 years
n=7 Participants
|
1.85 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
253 Participants
n=5 Participants
|
276 Participants
n=7 Participants
|
529 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
239 Participants
n=5 Participants
|
219 Participants
n=7 Participants
|
458 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
492 participants
n=5 Participants
|
495 participants
n=7 Participants
|
987 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From time of enrollment until the first MA-SSI or 12 months following enrollment, whichever came first.Medically attended skin and soft tissue infections (MA-SSI) which is defined as a skin or soft tissue infection that has been evaluated and treated by a medical professional in an office, clinic, urgent care or emergency center setting.
Outcome measures
| Measure |
Routine Measures
n=492 Participants
Routine Measures Group: Cultures will be obtained from the anterior nares of the nose, the throat and the groin using separate culturette swabs. S. aureus isolates will be identified and antibiotic susceptibility determined. Isolates will subsequently undergo testing for susceptibility to methicillin to determine if the isolate is an MSSA or MRSA strain. All patients and parents will be instructed orally and provided written instructions about routine measures employed for the prevention of S. aureus skin infections.
|
Bleach Baths
n=495 Participants
Bleach Bath Group: Cultures will be obtained from the anterior nares of the nose, the throat and the groin using culturette swabs. S. aureus isolates will be identified and antibiotic susceptibility determined. Isolates will subsequently undergo testing for susceptibility to methicillin to determine if the isolate is an MSSA or MRSA strain. Patients and parents will be instructed orally and provided written instructions about routine measures employed for the prevention of S. aureus skin infections. Patients will be given further oral and written instructions regarding clorox baths.
|
|---|---|---|
|
Medically Attended Skin and Soft Tissue Infections (MA-SSI)
|
20.9 percentage of partipants
Interval 17.3 to 24.5
|
17 percentage of partipants
Interval 13.7 to 20.3
|
Adverse Events
Routine Measures
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Bleach Baths
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Routine Measures
n=492 participants at risk
Routine Measures Group: Cultures will be obtained from the anterior nares of the nose, the throat and the groin using separate culturette swabs. S. aureus isolates will be identified and antibiotic susceptibility determined. Isolates will subsequently undergo testing for susceptibility to methicillin to determine if the isolate is an MSSA or MRSA strain. All patients and parents will be instructed orally and provided written instructions about routine measures employed for the prevention of S. aureus skin infections.
|
Bleach Baths
n=495 participants at risk
Bleach Bath Group: Cultures will be obtained from the anterior nares of the nose, the throat and the groin using culturette swabs. S. aureus isolates will be identified and antibiotic susceptibility determined. Isolates will subsequently undergo testing for susceptibility to methicillin to determine if the isolate is an MSSA or MRSA strain. Patients and parents will be instructed orally and provided written instructions about routine measures employed for the prevention of S. aureus skin infections. Patients will be given further oral and written instructions regarding clorox baths.
|
|---|---|---|
|
Eye disorders
Burning eyes
|
0.00%
0/492
|
0.20%
1/495
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place