Staphylococcal Skin InfectionsSuDSNCT00731783
Staphylococcus Aureus Decolonization Study
A study testing 2% Mupirocin Ointment, 4% Chlorhexidine liquid soap and Hygiene protocol in people with Staphylococcal Skin Infections and Abscesses, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to determine whether measures to eliminate the Staph germ from the skin of the index patient (with a special ointment and soap) are more effective when performed by everyone in the household rather than the patient alone, and whether these methods are effective in preventing future Staph… Read more about this study
- Who is it for?
- Ages 6 months to 21 years
- Conditions the study is for
- Staphylococcal Skin Infections, Abscesses, Furunculosis
- What is being tested?
- 2% Mupirocin Ointment, 4% Chlorhexidine liquid soap and Hygiene protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to 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 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Screening:
- Children aged 6 months to 21 years presenting with an active skin or soft tissue infection.
- Enrollment:
- Positive MRSA culture from the abscess and from either the axilla, anterior nares or groin area (signifying both infection and colonization with MRSA).
Who cannot join
- Infants less than 6 months of age
- Dialysis or residence in a long term care facility over the past year
- Use of chlorhexidine or mupirocin in the past one month
- Pregnancy
- Immunodeficiency
- History of an adverse reaction to chlorhexidine or mupirocin.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Louis Children's Hospital
St Louis, Missouri, 63110
About this study
Official title: Household vs. Individual Approach to Decolonization of Community-acquired Methicillin-resistant Staphylococcus Aureus.
The purpose of this study is to determine whether measures to eliminate the Staph germ from the skin of the index patient (with a special ointment and soap) are more effective when performed by everyone in the household rather than the patient alone, and whether these methods are effective in preventing future Staph infections. The investigators hypothesize that there will be a greater number of households who are successful in eradicating the staph germ from the index patient when all members of the household participate than households where only the index patient is treated.
Read the detailed description
Methicillin-resistant Staphylococcus aureus (MRSA) was once uniformly associated with hospital-acquired infections; however, MRSA strains have emerged that thrive outside the hospital environment, causing significant morbidity and mortality among immunocompetent individuals, leading to their designation as community-acquired methicillin resistant Staphylococcus aureus (CA-MRSA).
CA-MRSA has become a major source of morbidity and mortality in our pediatric population. An important prerequisite for S. aureus infection may be nasal carriage of the organism. A variety of decolonization strategies have been used for infection prophylaxis, primarily in patients undergoing hemodialysis or surgery, with varying results. However, there are no published randomized eradication trials evaluating the decolonization and prevention of CA-MRSA infections in immunocompetent children in the outpatient setting. While the transmission of CA-MRSA within households has been reported, its contribution to recurrent CA-MRSA infection among household members is undetermined. The investigators hypothesize that spread of CA-MRSA among household members leads to recolonization or failure of decolonization in children undergoing eradication efforts.
Specific Aim: In pediatric patients presenting with a MRSA skin or soft tissue infection, compare the effectiveness of decolonization measures performed by an entire household in comparison to measures directed at the index patient alone. The investigators will conduct a randomized, controlled trial to test the hypothesis that decolonization measures performed by the entire household, specifically application of intranasal mupirocin ointment and bathing with chlorhexidine liquid soap, in addition to education and basic hygiene interventions, will be twice as effective in eradicating CA-MRSA carriage in the index patient than if the measures are performed only by the index patient.
- Conditions
- Staphylococcal Skin Infections, Abscesses, Furunculosis, Staphylococcus Aureus, MRSA Infection
- Being tested
- 2% Mupirocin Ointment, 4% Chlorhexidine liquid soap, Hygiene protocol
- Keywords
- Abscesses, Furunculosis, Staphylococcus aureus colonization, Staphylococcal Skin Infections, MRSA
- Medical subject headings
- Staphylococcal Skin Infections, Abscess, Furunculosis, Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2% Mupirocin OintmentDrug
Also called Bactroban
Apply ointment to the anterior nares twice daily for 5 days.
4% Chlorhexidine liquid soapDrug
Also called Hibiclens
Bathe with liquid soap daily for 5 days.
Hygiene protocolBehavioural
Follow key hygiene tips indefinitely. Tips are:
- Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles.
- Use liquid(pour or pump) soaps instead of bar soaps.
- Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell.
- Do not share personal care items such as razors and brushes.
- Wash all sheets and towels in hot water. Wash sheets every week.
- Use towels and wash cloths only once before washing and do not share.
| Study group | Role | What they receive |
|---|---|---|
| Index patient only | Active comparator | Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen. Receives: Drug: 2% Mupirocin Ointment; Drug: 4% Chlorhexidine liquid soap; Behavioral: Hygiene protocol |
| Household | Active comparator | All members of the household (over the age of 6 months) will be asked to follow the study protocol. Receives: Drug: 2% Mupirocin Ointment; Drug: 4% Chlorhexidine liquid soap; Behavioral: Hygiene protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Index Patients Eradicated of S. Aureus Carriage - 1 Month After Performing Decolonization Measures
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.
Measured: 1 month after enrollment.
Secondary outcomes (7)
Number of Index Patients Eradicated of S. Aureus Carriage - 3 Month After Performing Decolonization Measures
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.
Measured: 3 month after enrollment.
Number of Index Patients Eradicated of S. Aureus Carriage - 6 Month After Performing Decolonization Measures
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.
Measured: 6 month after enrollment.
Number of Index Patients Eradicated of S. Aureus Carriage - 12 Month After Performing Decolonization Measures
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.
Measured: 12 month after enrollment.
Recurrence of CA-MRSA Skin or Soft Tissue Infection - 1 Month After Enrollment.
Recurrence of CA-MRSA Skin or Soft Tissue Infection
Measured: 1 month after enrollment
Recurrence of CA-MRSA Skin or Soft Tissue Infection - 3 Month After Enrollment.
Recurrence of CA-MRSA Skin or Soft Tissue Infection
Measured: 3 month after enrollment
Recurrence of CA-MRSA Skin or Soft Tissue Infection - 6 Month After Enrollment.
Recurrence of CA-MRSA Skin or Soft Tissue Infection
Measured: 6 month after enrollment
Recurrence of CA-MRSA Skin or Soft Tissue Infection - 12 Month After Enrollment.
Recurrence of CA-MRSA Skin or Soft Tissue Infection
Measured: 12 month after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2008 (estimated)
- Study startJul 2008
- Primary completionJan 2010
- 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 Staphylococcal Skin InfectionsStudies 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
- 183 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
- Stephanie A Fritz, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00731783
- Sponsor's protocol ID
- 3177 38145
- Acronym
- SuDS
- Status last verified
- Apr 2012
- First submitted
- 7 Aug 2008
- Last updated
- 30 Apr 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Fritz SA, Hogan PG, Hayek G, Eisenstein KA, Rodriguez M, Epplin EK, Garbutt J, Fraser VJ. Household versus individual approaches to eradication of community-associated Staphylococcus aureus in children: a randomized trial. Clin Infect Dis. 2012 Mar;54(6):743-51. doi: 10.1093/cid/cir919. Epub 2011 Dec 23.
PubMed 22198793
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Household vs. Individual Approach to Decolonization of Community-acquired Methicillin-resistant Staphylococcus Aureus.
- ClinicalTrials.gov ID
- NCT00731783
- Acronym / sponsor ID
- SuDS / 3177 38145
- Conditions
- Staphylococcal Skin Infections, Abscesses, Furunculosis, Staphylococcus Aureus, MRSA Infection
- Keywords
- Abscesses, Furunculosis, Staphylococcus aureus colonization, Staphylococcal Skin Infections, MRSA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 11 Aug 2008 (estimated)
- Results
- Posted 23 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 whether measures to eliminate the Staph germ from the skin of the index patient (with a special ointment and soap) are more effective when performed by everyone in the household rather than the patient alone, and whether these methods are effective in preventing future Staph infections. The investigators hypothesize that there will be a greater number of households who are successful in eradicating the staph germ from the index patient when all members of the household participate than households where only the index patient is treated.
Detailed description
Methicillin-resistant Staphylococcus aureus (MRSA) was once uniformly associated with hospital-acquired infections; however, MRSA strains have emerged that thrive outside the hospital environment, causing significant morbidity and mortality among immunocompetent individuals, leading to their designation as community-acquired methicillin resistant Staphylococcus aureus (CA-MRSA).
CA-MRSA has become a major source of morbidity and mortality in our pediatric population. An important prerequisite for S. aureus infection may be nasal carriage of the organism. A variety of decolonization strategies have been used for infection prophylaxis, primarily in patients undergoing hemodialysis or surgery, with varying results. However, there are no published randomized eradication trials evaluating the decolonization and prevention of CA-MRSA infections in immunocompetent children in the outpatient setting. While the transmission of CA-MRSA within households has been reported, its contribution to recurrent CA-MRSA infection among household members is undetermined. The investigators hypothesize that spread of CA-MRSA among household members leads to recolonization or failure of decolonization in children undergoing eradication efforts.
Specific Aim: In pediatric patients presenting with a MRSA skin or soft tissue infection, compare the effectiveness of decolonization measures performed by an entire household in comparison to measures directed at the index patient alone. The investigators will conduct a randomized, controlled trial to test the hypothesis that decolonization measures performed by the entire household, specifically application of intranasal mupirocin ointment and bathing with chlorhexidine liquid soap, in addition to education and basic hygiene interventions, will be twice as effective in eradicating CA-MRSA carriage in the index patient than if the measures are performed only by the index patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Index patient only | Active comparator | Drug: 2% Mupirocin Ointment, Drug: 4% Chlorhexidine liquid soap, Behavioral: Hygiene protocolOnly the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen. |
| Household | Active comparator | Drug: 2% Mupirocin Ointment, Drug: 4% Chlorhexidine liquid soap, Behavioral: Hygiene protocolAll members of the household (over the age of 6 months) will be asked to follow the study protocol. |
Who may qualify
- Ages
- 6 months to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Children aged 6 months to 21 years presenting with an active skin or soft tissue infection.
- Positive MRSA culture from the abscess and from either the axilla, anterior nares or groin area (signifying both infection and colonization with MRSA).
Key exclusion criteria (6 listed)
- Infants less than 6 months of age
- Dialysis or residence in a long term care facility over the past year
- Use of chlorhexidine or mupirocin in the past one month
- Pregnancy
- Immunodeficiency
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 |
|---|---|---|
| 2% Mupirocin OintmentAlso: BactrobanApply ointment to the anterior nares twice daily for 5 days. | Drug | Household, Index patient only |
| 4% Chlorhexidine liquid soapAlso: HibiclensBathe with liquid soap daily for 5 days. | Drug | Household, Index patient only |
| Hygiene protocolFollow key hygiene tips indefinitely. Tips are: * Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles. * Use liquid(pour or pump) soaps instead of bar soaps. * Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell. * Do not share personal care items such as razors and brushes. * Wash all sheets and towels in hot water. Wash sheets every week. * Use towels and wash cloths only once before washing and do not share. | Behavioural | Household, Index patient only |
Primary outcome
Number of Index Patients Eradicated of S. Aureus Carriage - 1 Month After Performing Decolonization Measures
Time frame: 1 month after enrollment.
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.
7 secondary outcomes
Number of Index Patients Eradicated of S. Aureus Carriage - 3 Month After Performing Decolonization Measures
Time frame: 3 month after enrollment.
Number of Index Patients Eradicated of S. Aureus Carriage - 6 Month After Performing Decolonization Measures
Time frame: 6 month after enrollment.
Number of Index Patients Eradicated of S. Aureus Carriage - 12 Month After Performing Decolonization Measures
Time frame: 12 month after enrollment.
Recurrence of CA-MRSA Skin or Soft Tissue Infection - 1 Month After Enrollment.
Time frame: 1 month after enrollment
Recurrence of CA-MRSA Skin or Soft Tissue Infection - 3 Month After Enrollment.
Time frame: 3 month after enrollment
Recurrence of CA-MRSA Skin or Soft Tissue Infection - 6 Month After Enrollment.
Time frame: 6 month after enrollment
Recurrence of CA-MRSA Skin or Soft Tissue Infection - 12 Month After Enrollment.
Time frame: 12 month after enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22198793Fritz SA, Hogan PG, Hayek G, Eisenstein KA, Rodriguez M, Epplin EK, Garbutt J, Fraser VJ. Household versus individual approaches to eradication of community-associated Staphylococcus aureus in children: a randomized trial. Clin Infect Dis. 2012 Mar;54(6):743-51. doi: 10.1093/cid/cir919. Epub 2011 Dec 23.
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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.
Stephanie A Fritz, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2% Mupirocin Ointment, 4% Chlorhexidine liquid soap and Hygiene protocol in people with Staphylococcal Skin Infections and Abscesses, run by Washington University School of Medicine 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 4 inclusion and 6 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 Apr 2012. 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?
Yes. Results are posted in the registry (first posted 23 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 Index Patients Eradicated of S. Aureus Carriage - 1 Month After Performing Decolonization Measures (time frame: 1 month after enrollment.). 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 NCT00731783, 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 Apr 2012.