Surveillance of Community-Associated MRSA

MRSA Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04083092
• Other study ID #: 14-166
• Status: Recruiting
• Start date: July 14, 2019
• Est. completion date: July 8, 2020

Study information

• Verified date: September 2019
• Source: Children's Healthcare of Atlanta
• Contact: Aziza Mustefa, MPH
• Phone: 404-785-4984
• Email: aziza.mustefa[@]choa.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 8, 2020
• Est. primary completion date: July 8, 2020
• Gender: All
• Age group: 6 Months to 21 Years

Eligibility

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)

Related Conditions & MeSH terms

• MRSA

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Children's Healthcare of Atlanta

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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