Surveillance of Community-Associated MRSA

NCT ID: NCT04083092

Last Updated: 2019-09-10

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-07-14
• Study Completion Date: 2020-07-08

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.

Conditions

MRSA

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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)

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Healthcare of Atlanta

OTHER

Sponsor Role: lead

Responsible Party

Lilly

Pediatric Infectious Disease Specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Aziza Mustefa, MPH

Role: CONTACT

aziza.mustefa@choa.org

404-785-4984

Facility Contacts

Aziza Mustefa, MPH

Role: primary

Other Identifiers

14-166

Identifier Type: -

Identifier Source: org_study_id