MRSACIRCUSNCT02690415
Community-Assoc. S. Aureus Colonization and Recurrent Infection in Pts With Uncomplicated S. Aureus Skin Abscesses
An observational study of MRSA, run by Southern Illinois University at 1 site in United States.
Trial summary
Infections due to S. aureus are a major healthcare burden. Currently there is not an effective way to prevent S. aureus infection. Treatment failure can happen in up to 20% of patients with SSTI and mean additional cost per patient can be over $1500. Antibiotics are often prescribed for the treatment of CA-S. Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- MRSA
- What is being tested?
- Antibiotics Given and Antibiotics not given
- Type of treatment
- Surgery or procedure
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Sep 2017
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric patients presenting in the Emergency Department or Express Cares and Primary Care Clinics with skin abscesses who do and do not receive antibiotic therapy at two time points.
Who may be able to join
- (1) Children 6 months to 18 years presenting with a skin abscess.
- (2) Positive MRSA or MSSA culture from previous or current abscess
Who cannot join
- (1) Immunodeficiency;
- (2) Hospitalization within the prior 14 days
- (3) Use of mupirocin, clorhexidine or bleach water baths in the last month
- (4) Systemic antibacterial therapy with anti-staphylococcal activity within the prior 14 days.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Antibiotics on Community-Associated Staphylococcus Aureus Colonization and Recurrent Infection in Patients With Uncomplicated S. Aureus Skin Abscesses
Infections due to S. aureus are a major healthcare burden. Currently there is not an effective way to prevent S. aureus infection. Treatment failure can happen in up to 20% of patients with SSTI and mean additional cost per patient can be over $1500. Antibiotics are often prescribed for the treatment of CA-S. aureus SSTI. Current IDSA CA-MRSA guidelines suggest that incision and drainage alone may be adequate for management of uncomplicated CA-S. aureus skin abscesses and there is uncertainty about the need of antibiotics. It is not known whether antibiotics are helpful in decreasing S. aureus colonization rates or preventing future S. aureus infections. Though resolution of acute abscess after drainage may be unchanged by antibiotic administration, the impact of managing S. aureus abscess without antibiotics on ongoing S. aureus colonization and recurrent infection requires further study. This study seeks to examine whether the management of initial S. aureus abscesses with incision and drainage in addition to antibiotic therapy is an effective means of preventing recurrent infection. The prolonged longitudinal follow-up of this study is another unique characteristic that will enable the investigators to capture data about recurrences of infections.
Read the detailed description
Methicillin-resistant Staphylococcus aureus (MRSA) was once associated almost exclusively with healthcare-associated infections. However, new epidemic strains have emerged outside of the healthcare environment designated community-associated (CA) MRSA. From 1999 to 2005, hospitalizations for Staphylococcus aureus-related skin and soft tissue infections (SSTI) in the United States increased 4-fold to nearly 90,000 annually. At Memorial Medical Center (MMC) Emergency Department (ED) and Express Cares (EC) there have been over 6500 visits in the last 6 years secondary to SSTI.
Current Infectious Diseases Society of America (IDSA) guidelines suggest incision and drainage alone (without antibiotics) may be adequate management for uncomplicated MRSA skin abscesses. However, patients not receiving antibiotics are more likely to develop recurrent infections, which may be a result of persistent MRSA colonization. The investigators will conduct a prospective case-control study at MMC ED, EC and MMC primary care clinics of pediatric patients with skin abscesses comparing outcomes for those who received antibiotics (cases) versus those who did not (controls). This will not be an intervention study - both surgical and medical management of patients with skin abscesses will be at the discretion of the treating physician.
The central hypothesis is that the inclusion of systemic antibiotics in the management of S. aureus skin abscesses will decrease S. aureus colonization, and subsequently the incidence of recurrent SSTI in the year following baseline infection. To gain a better understanding of this problem, the investigators propose the following specific aims:
- Conditions
- MRSA
- Being tested
- Antibiotics Given, Antibiotics not given
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibiotics GivenProcedure or surgery
Patients who's treating physician prescribed antibiotics
Antibiotics not givenProcedure or surgery
Patients who's treating physician did not prescribed antibiotics
| Study group | Role | What they receive |
|---|---|---|
| Antibiotics Given | Patients who's treating physician prescribed antibiotics following incision and drainage of their abscess. Receives: Procedure: Antibiotics Given; Procedure: Antibiotics not given | |
| Antibiotics Not Given | Patients who's treating physician did not prescribed antibiotics following incision and drainage of their abscess. Receives: Procedure: Antibiotics Given; Procedure: Antibiotics not given |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine if there is a change in colonization status from baseline
To determine S. aureus colonization status at three body sites (nose, axilla and inguinal folds) in pediatric patients presenting in the Emergency Department or Express Cares and Primary Care Clinics with skin abscesses who do and do not receive antibiotic therapy at two time points.
Measured: At the time of surgical incision and drainage of the baseline skin abscess and 1 month post
Measure incidence of recurrent SSTI
To measure incidence of recurrent SSTI at 1, 3, 6 and 12 months in patients who did or did not receive antibiotic therapy.
Measured: 1, 3, 6 and 12 months
Secondary outcomes (1)
Measure S. aureus antibiotic resistance in patients who did and did not receive antibiotics
Measured: At the time of surgical incision and drainage of the baseline skin abscess and 1 month post
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2016 (estimated)
- Study startJun 2015
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southern Illinois University
- Sponsor type
- University, hospital or other
- Collaborators
- Washington University School of Medicine
- Responsible party
- Sponsor
- Investigators
- Marcela Rodriguez, MD, Principal investigator, SIU School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02690415
- Sponsor's protocol ID
- ROD-SIU-14-197-CIRCUS
- Acronym
- CIRCUS
- Status last verified
- Jun 2020
- First submitted
- 11 Feb 2016
- Last updated
- 1 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hogan, Patrick G., et al.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Antibiotics on Community-Associated Staphylococcus Aureus Colonization and Recurrent Infection in Patients With Uncomplicated S. Aureus Skin Abscesses
- ClinicalTrials.gov ID
- NCT02690415
- Acronym / sponsor ID
- CIRCUS / ROD-SIU-14-197-CIRCUS
- Conditions
- MRSA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Southern Illinois UniversityUniversity, hospital or other
- Collaborators
- Washington University School of Medicine
- Study start
- Jun 2015 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 24 Feb 2016 (estimated)
- 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.
Infections due to S. aureus are a major healthcare burden. Currently there is not an effective way to prevent S. aureus infection. Treatment failure can happen in up to 20% of patients with SSTI and mean additional cost per patient can be over $1500. Antibiotics are often prescribed for the treatment of CA-S. aureus SSTI. Current IDSA CA-MRSA guidelines suggest that incision and drainage alone may be adequate for management of uncomplicated CA-S. aureus skin abscesses and there is uncertainty about the need of antibiotics. It is not known whether antibiotics are helpful in decreasing S. aureus colonization rates or preventing future S. aureus infections. Though resolution of acute abscess after drainage may be unchanged by antibiotic administration, the impact of managing S. aureus abscess without antibiotics on ongoing S. aureus colonization and recurrent infection requires further study. This study seeks to examine whether the management of initial S. aureus abscesses with incision and drainage in addition to antibiotic therapy is an effective means of preventing recurrent infection. The prolonged longitudinal follow-up of this study is another unique characteristic that will enable the investigators to capture data about recurrences of infections.
Detailed description
Methicillin-resistant Staphylococcus aureus (MRSA) was once associated almost exclusively with healthcare-associated infections. However, new epidemic strains have emerged outside of the healthcare environment designated community-associated (CA) MRSA. From 1999 to 2005, hospitalizations for Staphylococcus aureus-related skin and soft tissue infections (SSTI) in the United States increased 4-fold to nearly 90,000 annually. At Memorial Medical Center (MMC) Emergency Department (ED) and Express Cares (EC) there have been over 6500 visits in the last 6 years secondary to SSTI.
Current Infectious Diseases Society of America (IDSA) guidelines suggest incision and drainage alone (without antibiotics) may be adequate management for uncomplicated MRSA skin abscesses. However, patients not receiving antibiotics are more likely to develop recurrent infections, which may be a result of persistent MRSA colonization. The investigators will conduct a prospective case-control study at MMC ED, EC and MMC primary care clinics of pediatric patients with skin abscesses comparing outcomes for those who received antibiotics (cases) versus those who did not (controls). This will not be an intervention study - both surgical and medical management of patients with skin abscesses will be at the discretion of the treating physician.
The central hypothesis is that the inclusion of systemic antibiotics in the management of S. aureus skin abscesses will decrease S. aureus colonization, and subsequently the incidence of recurrent SSTI in the year following baseline infection. To gain a better understanding of this problem, the investigators propose the following specific aims:
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antibiotics Given | – | Procedure: Antibiotics Given, Procedure: Antibiotics not givenPatients who's treating physician prescribed antibiotics following incision and drainage of their abscess. |
| Antibiotics Not Given | – | Procedure: Antibiotics Given, Procedure: Antibiotics not givenPatients who's treating physician did not prescribed antibiotics following incision and drainage of their abscess. |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients presenting in the Emergency Department or Express Cares and Primary Care Clinics with skin abscesses who do and do not receive antibiotic therapy at two time points.
Key inclusion criteria (2 listed)
- (1) Children 6 months to 18 years presenting with a skin abscess.
- (2) Positive MRSA or MSSA culture from previous or current abscess
Key exclusion criteria (4 listed)
- (1) Immunodeficiency;
- (2) Hospitalization within the prior 14 days
- (3) Use of mupirocin, clorhexidine or bleach water baths in the last month
- (4) Systemic antibacterial therapy with anti-staphylococcal activity within the prior 14 days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antibiotics GivenPatients who's treating physician prescribed antibiotics | Procedure or surgery | Antibiotics Given, Antibiotics Not Given |
| Antibiotics not givenPatients who's treating physician did not prescribed antibiotics | Procedure or surgery | Antibiotics Given, Antibiotics Not Given |
Primary outcome
Determine if there is a change in colonization status from baseline
Time frame: At the time of surgical incision and drainage of the baseline skin abscess and 1 month post
To determine S. aureus colonization status at three body sites (nose, axilla and inguinal folds) in pediatric patients presenting in the Emergency Department or Express Cares and Primary Care Clinics with skin abscesses who do and do not receive antibiotic therapy at two time points.
Measure incidence of recurrent SSTI
Time frame: 1, 3, 6 and 12 months
To measure incidence of recurrent SSTI at 1, 3, 6 and 12 months in patients who did or did not receive antibiotic therapy.
1 secondary outcome
Measure S. aureus antibiotic resistance in patients who did and did not receive antibiotics
Time frame: At the time of surgical incision and drainage of the baseline skin abscess and 1 month post
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2020.
- Results publicationHogan, Patrick G., et al.
- Individual participant dataSharing planned: No
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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.
Marcela Rodriguez, MD principal investigator
SIU School of Medicine
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 Southern Illinois University 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 4 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: finished, as of the sponsor's last update on 1 Jul 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine if there is a change in colonization status from baseline (time frame: At the time of surgical incision and drainage of the baseline skin abscess and 1 month post). 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?
On the ClinicalTrials.gov record for NCT02690415, which also lists 1 linked publication.
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 1 Jul 2020.