AbscessesStLStaRSNCT00513799
The Natural History of Community-Associated MRSA Infections and Decolonization Strategies
A study testing Mupirocin ointment, Chlorhexidine showers and Bleach baths (dilute) in people with Abscesses and Furunculosis, run by Washington University School of Medicine at 2 sites in United States.
Trial summary
The purpose of this study is to determine the natural history of community-associated Staphylococcus aureus infections in both adult and pediatric patients by monitoring the rate of recurrent infections in those colonized with S. aureus. Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- Abscesses, Furunculosis, Staphylococcus Aureus
- What is being tested?
- Mupirocin ointment, Chlorhexidine showers and Bleach baths (dilute)
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2007to Dec 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Any patient who presents with at least one serious skin or soft tissue infection requiring incision and drainage at an affiliated institution or clinic in the St. Louis metropolitan area
Who cannot join
- Patients with permanent indwelling catheters or percutaneous medical devices
- Patients with a history of dialysis treatments, long term care facility admission, or presents with a surgical wound infection within the past year
- Patients who are pregnant
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Barnes-Jewish Hospital
St Louis, Missouri, 63110
St. Louis Children's Hospital
St Louis, Missouri, 63110
About this study
Official title: The Natural History of Community-Associated Methicillin-Resistant Staphylococcus Aureus (CA-MRSA) Infections and an Evaluation of Decolonization Strategies
The purpose of this study is to determine the natural history of community-associated Staphylococcus aureus infections in both adult and pediatric patients by monitoring the rate of recurrent infections in those colonized with S. aureus.
In addition, this study will evaluate the efficiency of commonly prescribed decolonization measures in patients presenting with S. aureus skin and soft tissue infections.
Read the detailed description
Infections with community-associated methicillin-resistant Staphylococcus aureus (CA-MRSA) range in severity from superficial skin abscesses to invasive soft tissue infections like cellulitis and pyomyositis. There has been a large increase in the number of patients presenting to our institution with CA-MRSA infections. Colonization with S. aureus (SA) may be linked to the development of infection but data on this phenomenon are limited. The recurrence rate for CA-MRSA soft tissue infections is unknown. A variety of decolonization strategies have been used for infection prophylaxis with varying results, primarily in patients undergoing hemodialysis or surgery. This study seeks to determine the recurrence rate of soft tissue infections among patients with CA-MRSA infections and to determine a reasonable and efficacious decolonization strategy to eradicate CA-MRSA from previously infected patients.
The proposed methods for decolonization will be tested in a randomized controlled trial with four intervention arms. The intervention arms are: (1) intensive education on prevention of skin infections through improvements in personal hygiene (also serves as "control group"), (2) application of mupirocin in the nasal mucosa alone, (3) a combination of nasal application of mupirocin and chlorhexidine showers, and (4) a combination of nasal application of mupirocin and bathing in dilute bleach water. The "control" group as well as the three other arms will receive intensive hygiene education.
Decolonization with mupirocin ointment and chlorhexidine showers or dilute bleach baths in combination are likely to be more successful than either the application of nasal mupirocin ointment alone or hygiene measures alone. It is expected that these decolonization methods will result in a 50% relative reduction in MRSA colonization at 6 months.
- Being tested
- Mupirocin ointment, Chlorhexidine showers, Bleach baths (dilute), Intensive education on personal hygiene
- Medical subject headings
- Abscess, Furunculosis, Staphylococcal Infections, Staphylococcal Skin Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mupirocin ointmentDrug
Also called Bactroban
Add a small amount of Mupirocin to the cotton end of a swab. Swab in inner nostril, then repeat in other nostril using new cotton swab with ointment. Twice daily treatment for 5 days.
Chlorhexidine showersGenetic
Also called Hibiclens
Apply Clorhexidine wash to entire body once daily for 5 days.
Bleach baths (dilute)Procedure or surgery
Also called Clorox
Pour 2 ounces of bleach into water-filled bath tub. Soak in bath for 15 minutes. Apply once daily for 5 days.
Intensive education on personal hygieneBehavioural
Repeat hygiene methods for 5 days.
| Study group | Role | What they receive |
|---|---|---|
| 1: Hygiene Education | Active comparator | Intensive education on prevention of skin infections through improvements in personal hygiene (also serves as "control group") Receives: Behavioral: Intensive education on personal hygiene |
| 2: Hygiene education + mupirocin | Active comparator | Application of mupirocin in the nasal mucosa alone Receives: Drug: Mupirocin ointment; Behavioral: Intensive education on personal hygiene |
| Education + mupirocin + chlorhexidine | Active comparator | A combination of nasal application of mupirocin and chlorhexidine showers Receives: Drug: Mupirocin ointment; Genetic: Chlorhexidine showers; Behavioral: Intensive education on personal hygiene |
| 4: Education + mupirocin + bleach baths | Active comparator | A combination of nasal application of mupirocin and bathing in dilute bleach water Receives: Drug: Mupirocin ointment; Procedure: Bleach baths (dilute); Behavioral: Intensive education on personal hygiene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Eradicated of S. Aureus Carriage - 1 Month After Intervention
Eradication is defined as the absence of S. aureus carriage at the 3 sampled body sites (anterior nares, axilla, inguinal folds) of the index patient. Samples obtained by study team at follow-up visit.
Measured: 1 month follow-up
Secondary outcomes (2)
Number of Participants With Recurrent Staphylococcus Aureus Skin or Soft Tissue Infection
Recurrent Staphylococcus aureus Skin or Soft Tissue Infection is defined as incidence of skin abscess, impetigo, cellulitis, or spider bite in the 1 month following intervention. Infections reported by participant at follow-up visit.
Measured: 1, 4 and 6 month follow-ups
Number of Participants Eradicated of S. Aureus Carriage - 4 Months After Intervention
Eradication is defined as the absence of S. aureus carriage at the 3 sampled body sites (anterior nares, axilla, inguinal folds) of the index patient. Samples obtained by study team at follow-up visit.
Measured: 4 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2007 (estimated)
- Study startMar 2007
- Primary completionJun 2009
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AbscessesStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephanie A. Fritz, Washington University School of Medicine
- Investigators
- Bernard C. Camins, MD, MSCR, Principal investigator, Assistant Professor of Medicine, Division of Infectious Diseases, Department of Medicine, Washington University School of MedicineGregory A. Storch, MD, Principal investigator, Professor of Medicine and Molecular Microbiology, Chief of Division of Pediatric Infectious Diseases, Department of Medicine, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00513799
- Sponsor's protocol ID
- 9000C4
- Acronym
- StLStaRS
- Status last verified
- Jul 2015
- First submitted
- 8 Aug 2007
- Last updated
- 30 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Fritz SA, Camins BC, Eisenstein KA, Fritz JM, Epplin EK, Burnham CA, Dukes J, Storch GA. Effectiveness of measures to eradicate Staphylococcus aureus carriage in patients with community-associated skin and soft-tissue infections: a randomized trial. Infect Control Hosp Epidemiol. 2011 Sep;32(9):872-80. doi: 10.1086/661285.
PubMed 21828967
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Natural History of Community-Associated Methicillin-Resistant Staphylococcus Aureus (CA-MRSA) Infections and an Evaluation of Decolonization Strategies
- ClinicalTrials.gov ID
- NCT00513799
- Acronym / sponsor ID
- StLStaRS / 9000C4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 9 Aug 2007 (estimated)
- Results
- Posted 29 Mar 2011
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 determine the natural history of community-associated Staphylococcus aureus infections in both adult and pediatric patients by monitoring the rate of recurrent infections in those colonized with S. aureus.
In addition, this study will evaluate the efficiency of commonly prescribed decolonization measures in patients presenting with S. aureus skin and soft tissue infections.
Detailed description
Infections with community-associated methicillin-resistant Staphylococcus aureus (CA-MRSA) range in severity from superficial skin abscesses to invasive soft tissue infections like cellulitis and pyomyositis. There has been a large increase in the number of patients presenting to our institution with CA-MRSA infections. Colonization with S. aureus (SA) may be linked to the development of infection but data on this phenomenon are limited. The recurrence rate for CA-MRSA soft tissue infections is unknown. A variety of decolonization strategies have been used for infection prophylaxis with varying results, primarily in patients undergoing hemodialysis or surgery. This study seeks to determine the recurrence rate of soft tissue infections among patients with CA-MRSA infections and to determine a reasonable and efficacious decolonization strategy to eradicate CA-MRSA from previously infected patients.
The proposed methods for decolonization will be tested in a randomized controlled trial with four intervention arms. The intervention arms are: (1) intensive education on prevention of skin infections through improvements in personal hygiene (also serves as "control group"), (2) application of mupirocin in the nasal mucosa alone, (3) a combination of nasal application of mupirocin and chlorhexidine showers, and (4) a combination of nasal application of mupirocin and bathing in dilute bleach water. The "control" group as well as the three other arms will receive intensive hygiene education.
Decolonization with mupirocin ointment and chlorhexidine showers or dilute bleach baths in combination are likely to be more successful than either the application of nasal mupirocin ointment alone or hygiene measures alone. It is expected that these decolonization methods will result in a 50% relative reduction in MRSA colonization at 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1: Hygiene Education | Active comparator | Behavioral: Intensive education on personal hygieneIntensive education on prevention of skin infections through improvements in personal hygiene (also serves as "control group") |
| 2: Hygiene education + mupirocin | Active comparator | Drug: Mupirocin ointment, Behavioral: Intensive education on personal hygieneApplication of mupirocin in the nasal mucosa alone |
| Education + mupirocin + chlorhexidine | Active comparator | Drug: Mupirocin ointment, Genetic: Chlorhexidine showers, Behavioral: Intensive education on personal hygieneA combination of nasal application of mupirocin and chlorhexidine showers |
| 4: Education + mupirocin + bleach baths | Active comparator | Drug: Mupirocin ointment, Procedure: Bleach baths (dilute), Behavioral: Intensive education on personal hygieneA combination of nasal application of mupirocin and bathing in dilute bleach water |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Any patient who presents with at least one serious skin or soft tissue infection requiring incision and drainage at an affiliated institution or clinic in the St. Louis metropolitan area
Key exclusion criteria (3 listed)
- Patients with permanent indwelling catheters or percutaneous medical devices
- Patients with a history of dialysis treatments, long term care facility admission, or presents with a surgical wound infection within the past year
- Patients who are pregnant
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 |
|---|---|---|
| Mupirocin ointmentAlso: BactrobanAdd a small amount of Mupirocin to the cotton end of a swab. Swab in inner nostril, then repeat in other nostril using new cotton swab with ointment. Twice daily treatment for 5 days. | Drug | 2: Hygiene education + mupirocin, 4: Education + mupirocin + bleach baths, Education + mupirocin + chlorhexidine |
| Chlorhexidine showersAlso: HibiclensApply Clorhexidine wash to entire body once daily for 5 days. | Genetic | Education + mupirocin + chlorhexidine |
| Bleach baths (dilute)Also: CloroxPour 2 ounces of bleach into water-filled bath tub. Soak in bath for 15 minutes. Apply once daily for 5 days. | Procedure or surgery | 4: Education + mupirocin + bleach baths |
| Intensive education on personal hygieneRepeat hygiene methods for 5 days. | Behavioural | 1: Hygiene Education, 2: Hygiene education + mupirocin, 4: Education + mupirocin + bleach baths, Education + mupirocin + chlorhexidine |
Primary outcome
Number of Participants Eradicated of S. Aureus Carriage - 1 Month After Intervention
Time frame: 1 month follow-up
Eradication is defined as the absence of S. aureus carriage at the 3 sampled body sites (anterior nares, axilla, inguinal folds) of the index patient. Samples obtained by study team at follow-up visit.
2 secondary outcomes
Number of Participants With Recurrent Staphylococcus Aureus Skin or Soft Tissue Infection
Time frame: 1, 4 and 6 month follow-ups
Number of Participants Eradicated of S. Aureus Carriage - 4 Months After Intervention
Time frame: 4 month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21828967Fritz SA, Camins BC, Eisenstein KA, Fritz JM, Epplin EK, Burnham CA, Dukes J, Storch GA. Effectiveness of measures to eradicate Staphylococcus aureus carriage in patients with community-associated skin and soft-tissue infections: a randomized trial. Infect Control Hosp Epidemiol. 2011 Sep;32(9):872-80. doi: 10.1086/661285.
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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.
Bernard C. Camins, MD, MSCR principal investigator
Assistant Professor of Medicine, Division of Infectious Diseases, Department of Medicine, Washington University School of Medicine
Gregory A. Storch, MD principal investigator
Professor of Medicine and Molecular Microbiology, Chief of Division of Pediatric Infectious Diseases, Department of Medicine, Washington University School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mupirocin ointment, Chlorhexidine showers and Bleach baths (dilute) in people with Abscesses and Furunculosis, run by Washington University School of Medicine at 2 sites 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 1 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: finished, as of the sponsor's last update on 30 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 29 Mar 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Eradicated of S. Aureus Carriage - 1 Month After Intervention (time frame: 1 month follow-up). 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 NCT00513799, 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 30 Jul 2015.