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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04083092
Other study ID # 14-166
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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)

Study Design


Related Conditions & MeSH terms


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
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