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Prevention of Recurrent Infections Caused by Community Acquired Staphylococcus Aureus (CA-SA) in Children

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ClinicalTrials.gov Identifier: NCT00901316
Recruitment Status : Completed
First Posted : May 13, 2009
Results First Posted : November 7, 2016
Last Update Posted : November 7, 2016
Sponsor:
Collaborator:
Texas Children's Hospital
Information provided by (Responsible Party):
Sheldon Kaplan, Baylor College of Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Community-Acquired Staphylococcus Aureus
Interventions Procedure: Routine Measures Group
Procedure: Bleach Bath Group (Bleach plus routine measures)
Enrollment 987
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Routine Measures Bleach Baths
Hide Arm/Group Description 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 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.
Period Title: Overall Study
Started 492 495
Completed 492 495
Not Completed 0 0
Arm/Group Title Routine Measures Bleach Baths Total
Hide Arm/Group Description 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 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 of all reporting groups
Overall Number of Baseline Participants 492 495 987
Hide Baseline Analysis Population Description
We needed to enroll 482 children in each arm to detect a 50% reduction in recurrences with 90% power, assuming a 12-month recurrence rate of 14% in the hygiene only group.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 492 participants 495 participants 987 participants
<=18 years
492
 100.0%
495
 100.0%
987
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 492 participants 495 participants 987 participants
1.92
(.26 to 18.8)
1.8
(.27 to 17.9)
1.85
(.26 to 18.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 492 participants 495 participants 987 participants
Female
253
  51.4%
276
  55.8%
529
  53.6%
Male
239
  48.6%
219
  44.2%
458
  46.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 492 participants 495 participants 987 participants
492 495 987
1.Primary Outcome
Title Medically Attended Skin and Soft Tissue Infections (MA-SSI)
Hide Description 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.
Time Frame From time of enrollment until the first MA-SSI or 12 months following enrollment, whichever came first.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Routine Measures Bleach Baths
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 492 495
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of partipants
20.9
(17.3 to 24.5)
17
(13.7 to 20.3)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Routine Measures Bleach Baths
Hide Arm/Group Description 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 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.
All-Cause Mortality
Routine Measures Bleach Baths
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Routine Measures Bleach Baths
Affected / at Risk (%) Affected / at Risk (%)
Total   0/492 (0.00%)   0/495 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events .01%
Routine Measures Bleach Baths
Affected / at Risk (%) Affected / at Risk (%)
Total   0/492 (0.00%)   1/495 (0.20%) 
Eye disorders     
Burning eyes * [1]  0/492 (0.00%)  1/495 (0.20%) 
*
Indicates events were collected by non-systematic assessment
[1]
Burning eyes
We were limited in detecting decreases in recurrent MA-SSTI < 50% because of the large sample size required.
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: Sheldon L. Kaplan, MD
Organization: Texas Children's Hospital
Phone: 832-824-4330
Responsible Party: Sheldon Kaplan, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00901316     History of Changes
Other Study ID Numbers: Thrasher21631
First Submitted: May 11, 2009
First Posted: May 13, 2009
Results First Submitted: July 20, 2016
Results First Posted: November 7, 2016
Last Update Posted: November 7, 2016