Clinical trial NCT04083092: Surveillance of Community-Associated MRSA
Official title: Surveillance of Community-Associated MRSA and Treatment Outcomes of Skin and Soft Tissue Infections in the Ambulatory Setting
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: MRSA
Lead sponsor: Children's Healthcare of Atlanta
Sponsor class: OTHER
First posted: 2019-09-10
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 21
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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

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.

Eligibility 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)

Primary outcomes:
measure: Number of children with MRSA and MSSA carriage
timeFrame: 1 year
measure: Number of children with MRSA and MSSA skin and soft tissue infections
timeFrame: 1 year
Secondary outcomes:
measure: Number of strains of MRSA and MSSA with unique genomic sequences
timeFrame: 1 year
measure: Percent relatedness between MRSA and MSSA protein profiles
timeFrame: 1 year
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
Study officials:
References: