MRSANCT04083092
Surveillance of Community-Associated MRSA
An observational study of MRSA, run by Children's Healthcare of Atlanta at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 6 months to 21 years
- Conditions the study is for
- MRSA
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2019to 8 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 21 years
- All sexes
- Child, Adult
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).
Who may be able to join
- Diagnosis of skin and soft tissue infections (abscesses and cellulitis)
- Patient aged >6 months and <21 years
Who cannot join
- Currently on antibiotics
- Unimmunized patients
- Pertinent co-morbid conditions (immune deficiency, underlying cardiac, skin, GI disorder)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Children's Healthcare of Atlanta
Atlanta, Georgia, 30342
Aziza Mustefa, MPH
About this study
Official title: 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
Read the 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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 year
Secondary outcomes (2)
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.
Measured: 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).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start14 Jul 2019
- Primary completion8 Jul 2020 (estimated)
- Study completion8 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MRSAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Healthcare of Atlanta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lilly, Children's Healthcare of Atlanta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04083092
- Sponsor's protocol ID
- 14-166
- Status last verified
- Sep 2019
- First submitted
- 29 Aug 2019
- Last updated
- 10 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surveillance of Community-Associated MRSA and Treatment Outcomes of Skin and Soft Tissue Infections in the Ambulatory Setting
- ClinicalTrials.gov ID
- NCT04083092
- Acronym / sponsor ID
- 14-166
- Conditions
- MRSA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Children's Healthcare of AtlantaUniversity, hospital or other
- Study start
- 14 Jul 2019 (actual)
- Primary completion
- 8 Jul 2020 (estimated)
- Study completion
- 8 Jul 2020 (estimated)
- First posted
- 10 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 months to 21 years
- Sex
- All
- Age groups
- Child, Adult
- 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).
Key inclusion criteria (2 listed)
- Diagnosis of skin and soft tissue infections (abscesses and cellulitis)
- Patient aged >6 months and <21 years
Key exclusion criteria (3 listed)
- Currently on antibiotics
- Unimmunized patients
- Pertinent co-morbid conditions (immune deficiency, underlying cardiac, skin, GI disorder)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of children with MRSA and MSSA carriage
Time frame: 1 year
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.
Number of children with MRSA and MSSA skin and soft tissue infections
Time frame: 1 year
We are measuring this by collecting wound cultures from all children who present with skin and soft issue infections.
2 secondary outcomes
Number of strains of MRSA and MSSA with unique genomic sequences
Time frame: 1 year
Percent relatedness between MRSA and MSSA protein profiles
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of MRSA, run by Children's Healthcare of Atlanta at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aziza Mustefa, MPH (404-785-4984, aziza.mustefa@choa.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of children with MRSA and MSSA carriage (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2019.