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Surveillance of Community-Associated MRSA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04083092
Recruitment Status : Recruiting
First Posted : September 10, 2019
Last Update Posted : September 10, 2019
Sponsor:
Information provided by (Responsible Party):
Lilly, Children's Healthcare of Atlanta

Brief Summary:
The purpose of this study is to obtain information from patients diagnosed with a skin and soft tissue infection (also known as an abscess or 'boil' or 'rising') and determine whether or not MRSA is present in the child's different surface skin areas or nose. We also plan to compare how these infections look in the lab, by identifying in detail parts of the germ that caused the infection or is found on the skin/nose areas

Condition or disease
MRSA

Detailed Description:
Patients come into the Emergency Department for skin and soft tissue infections, which could be caused by a germ not treatable with common medications. This germ is a bacterium called methicillin-resistant Staphylococcus aureus (MRSA). MRSA is a bacterium that has become resistant to certain antibiotics. Scientists and doctors are not sure what causes individuals to develop these infections, but it is believed to be related to the bacteria that might be on a patient's skin or in their nose. Patients will be interviewed by someone from the research team to gather more details about possible risk factors related to MRSA infections. Th interview is expected to last between 10-20 minutes. Nasal (nose), axillary (armpit), throat, and around rectum swabs will be obtained by the research team as follows: Culture swabs (similar to a large Q-tip) will be inserted gently into the front half of each nostril (nare), under each arm, in the throat area, and around the perirectal area (surface skin around rectal opening) either before or after being seen by the emergency room physician. Another culture swab of the patient's skin and soft tissue infection might be taken as part of their usual care for the child's condition or a swab culture will be taken from the infection site by research personnel. A 'culture' swab is a sterile Q-tip like swab which is used to collect potential bacteria from the skin and nose, and then can be used in the laboratory to grow the bacteria collected.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Surveillance of Community-Associated MRSA and Treatment Outcomes of Skin and Soft Tissue Infections in the Ambulatory Setting
Actual Study Start Date : July 14, 2019
Estimated Primary Completion Date : July 8, 2020
Estimated Study Completion Date : July 8, 2020



Primary Outcome Measures :
  1. Number of children with MRSA and MSSA carriage [ Time Frame: 1 year ]
    We are measuring this by swabbing 5 locations on the body of each study participant. We are swabbing the anterior nares (nostrils), under both axilla (armpits), oropharyngeal area (mouth), skin around the perirectal area, and the actual abscess wound.

  2. Number of children with MRSA and MSSA skin and soft tissue infections [ Time Frame: 1 year ]
    We are measuring this by collecting wound cultures from all children who present with skin and soft issue infections.


Secondary Outcome Measures :
  1. Number of strains of MRSA and MSSA with unique genomic sequences [ Time Frame: 1 year ]
    We are conducting genomic sequences. We want to understand the relationship between the different strains of MRSA and MSSA.

  2. Percent relatedness between MRSA and MSSA protein profiles [ Time Frame: 1 year ]
    Few studies have looked at the relationship between molecular characterization and treatment outcomes of children who present for skin and soft tissue infections. We will be using Matrix-assisted laser desorption ionization-time of flight (MALDI-TOF).



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Ages Eligible for Study:   6 Months to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population

Children's is the largest pediatric clinical care provider in the country. Currently, across the three hospitals (Hughes Spalding, Egleston, and Scottish Rite), there are 561 licensed beds. In 2013, CHOA managed more than 860,849 patient visits, with over 218,231 Emergency Department visits.

Enrolled patients will be tested for colonization by CA-MRSA and CA-MSSA by standard swabbing of specified sites (nares, axilla, oropharyngeal, and perirectal areas). A culture swab will also be taken of an enrolled patient's wound infection (skin and soft tissue infection).

Criteria

Inclusion Criteria:

  • Diagnosis of skin and soft tissue infections (abscesses and cellulitis)
  • Patient aged >6 months and <21 years

Exclusion Criteria:

  • Currently on antibiotics
  • Unimmunized patients
  • Pertinent co-morbid conditions (immune deficiency, underlying cardiac, skin, GI disorder)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04083092


Contacts
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Contact: Aziza Mustefa, MPH 404-785-4984 aziza.mustefa@choa.org

Locations
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United States, Georgia
Children's Healthcare of Atlanta Recruiting
Atlanta, Georgia, United States, 30342
Contact: Aziza Mustefa, MPH         
Sponsors and Collaborators
Children's Healthcare of Atlanta
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Responsible Party: Lilly, Pediatric Infectious Disease Specialist, Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier: NCT04083092    
Other Study ID Numbers: 14-166
First Posted: September 10, 2019    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No