Surveillance of Community-Associated MRSA

Surveillance of Community-Associated MRSA and Treatment Outcomes of Skin and Soft Tissue Infections in the Ambulatory Setting

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

Study Overview

• Status: Unknown
• Conditions: 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.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Aziza Mustefa, MPH; Phone Number: 404-785-4984; Email: aziza.mustefa@choa.org

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Recruiting
      • Children's Healthcare of Atlanta
      • Contact: Aziza Mustefa, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 21 years (Child, Adult)
• Accepts Healthy Volunteers: N/A
• Genders 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).

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of children with MRSA and MSSA carriage	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.	1 year
Number of children with MRSA and MSSA skin and soft tissue infections	We are measuring this by collecting wound cultures from all children who present with skin and soft issue infections.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of strains of MRSA and MSSA with unique genomic sequences	We are conducting genomic sequences. We want to understand the relationship between the different strains of MRSA and MSSA.	1 year
Percent relatedness between MRSA and MSSA protein profiles	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).	1 year

Collaborators and Investigators

• Sponsor: Children's Healthcare of Atlanta

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2019
• Primary Completion (Anticipated): July 8, 2020
• Study Completion (Anticipated): July 8, 2020

Study Registration Dates

• First Submitted: August 29, 2019
• First Submitted That Met QC Criteria: September 5, 2019
• First Posted (Actual): September 10, 2019

Study Record Updates

• Last Update Posted (Actual): September 10, 2019
• Last Update Submitted That Met QC Criteria: September 5, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 14-166

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No