NCT04083092

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 14, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 10, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2020

Completed
Last Updated

September 10, 2019

Status Verified

September 1, 2019

Enrollment Period

12 months

First QC Date

August 29, 2019

Last Update Submit

September 5, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Number of strains of MRSA and MSSA with unique genomic sequences

    1 year

  • Percent relatedness between MRSA and MSSA protein profiles

    1 year

Eligibility Criteria

Age6 Months - 21 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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).

You may qualify if:

  • Diagnosis of skin and soft tissue infections (abscesses and cellulitis)
  • Patient aged \>6 months and \<21 years

You may not qualify if:

  • Currently on antibiotics
  • Unimmunized patients
  • Pertinent co-morbid conditions (immune deficiency, underlying cardiac, skin, GI disorder)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30342, United States

RECRUITING

Central Study Contacts

Aziza Mustefa, MPH

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pediatric Infectious Disease Specialist

Study Record Dates

First Submitted

August 29, 2019

First Posted

September 10, 2019

Study Start

July 14, 2019

Primary Completion

July 8, 2020

Study Completion

July 8, 2020

Last Updated

September 10, 2019

Record last verified: 2019-09

Locations