Methicillin Resistant Staphylococcus Aureus Skin InfectionsNCT01049438
A Prospective Trial of Nasal Mupirocin, Hexachlorophene Body Wash, and Systemic Antibiotics for Prevention of Recurrent Methicillin Resistant Staphylococcus Aureus Infections
A study testing nasal mupirocin, topical 3% hexachlorophene body wash and oral anti-MRSA antibiotic in people with Methicillin Resistant Staphylococcus Aureus Skin Infections, run by Natividad Medical Center.
Trial summary
This clinical trial tests the hypothesis that body decolonization of patients with recurrent community-associated (CA) MRSA infections will significantly reduce the likelihood of recurrent CA-MRSA infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Methicillin Resistant Staphylococcus Aureus Skin Infections
- What is being tested?
- nasal mupirocin, topical 3% hexachlorophene body wash and oral anti-MRSA antibiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- Aug 2006to Sep 2009
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: recurrent MRSA infections and had greater than or equal to 2 MRSA infections in the 6 months prior to enrollment
About this study
This clinical trial tests the hypothesis that body decolonization of patients with recurrent community-associated (CA) MRSA infections will significantly reduce the likelihood of recurrent CA-MRSA infection.
Read the detailed description
Staphylococcus aureus is a ubiquitous pathogen, and causes infections of the skin, lung, bloodstream, and other body parts. Over the past decade,community-acquired methicillin resistant S. aureus (CA-MRSA) infections, which were previously extremely rare, are occurring commonly worldwide. CA-MRSA is the most common cause of skin infection in many locales in the U.S.
CA-MRSA strains are notable for their ability to spread in closed settings and cause recurrent infections among healthy persons. Management of recurrent CA-MRSA infection is challenging and optimal prevention strategies are undefined. Many experts recommend topical agents that decontaminate the body and/or anterior nares. However, there are no data that quantify the efficacy and safety of this approach.
We conducted a prospective non-comparative clinical trial to quantify the efficacy and safety of body decolonization regimens in the prevention of CA-MRSA infection from an Infectious Diseases private practice group in Northern California.
The study population comprised of persons suffering from recurrent CA-MRSA infection. For this clinical trial, all subjects will be given: nasal mupirocin (Bactroban Nasal, twice daily), topical 3% hexachlorophene body wash (Phisohex, daily), and an oral anti-MRSA antibiotic. The choice of oral antibiotic was based on investigators choice and antibiotic susceptibility of prior MRSA isolates in a given patient.
Patients were interviewed in person baseline and by phone at 2 weeks, 3 months, and 6 months using a standardized questionnaire. The baseline survey, based on a previously developed instrument used for an epidemiologic investigation of MRSA asked about MRSA risk factors and health-related quality of life. Follow up surveys asked about adverse drug effects, especially gastrointestinal and dermatologic side effects (2 week visit only) and incident skin and MRSA infections.
- Being tested
- nasal mupirocin, topical 3% hexachlorophene body wash, oral anti-MRSA antibiotic
- Keywords
- MRSA, Methicillin Resistant Staphylococcus aureus, Staphylococcus aureus, Skin Infections, Body Decolonization
- Medical subject headings
- Staphylococcal Infections, Cellulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nasal mupirocinDrug
Also called Bactrban Nasal
twice daily for 10 days
topical 3% hexachlorophene body washDrug
Also called Phisohex
daily for 10 days
oral anti-MRSA antibioticDrug
Also called trimethoprim-sulfamethoxazole, doxycycline, minocycline
The choice of oral antibiotic was based on investigators choice and antibiotic susceptibility of prior MRSA isolates in a given patient
| Study group | Role | What they receive |
|---|---|---|
| Nasal, body, and systemic decolonization | Experimental | Not described Receives: Drug: nasal mupirocin; Drug: topical 3% hexachlorophene body wash; Drug: oral anti-MRSA antibiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
A new MRSA or skin infection consistent with MRSA infection.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2010 (estimated)
- Study startAug 2006
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methicillin Resistant Staphylococcus Aureus Skin InfectionsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Natividad Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Allen Radner, M.D., Principal investigator, Navidad Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01049438
- Sponsor's protocol ID
- 20020519
- Status last verified
- Jan 2010
- First submitted
- 13 Jan 2010
- Last updated
- 14 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Trial of Nasal Mupirocin, Hexachlorophene Body Wash, and Systemic Antibiotics for Prevention of Recurrent Methicillin Resistant Staphylococcus Aureus Infections
- ClinicalTrials.gov ID
- NCT01049438
- Acronym / sponsor ID
- 20020519
- Keywords
- MRSA, Methicillin Resistant Staphylococcus aureus, Staphylococcus aureus, Skin Infections, Body Decolonization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Natividad Medical CenterUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 14 Jan 2010 (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.
This clinical trial tests the hypothesis that body decolonization of patients with recurrent community-associated (CA) MRSA infections will significantly reduce the likelihood of recurrent CA-MRSA infection.
Detailed description
Staphylococcus aureus is a ubiquitous pathogen, and causes infections of the skin, lung, bloodstream, and other body parts. Over the past decade,community-acquired methicillin resistant S. aureus (CA-MRSA) infections, which were previously extremely rare, are occurring commonly worldwide. CA-MRSA is the most common cause of skin infection in many locales in the U.S.
CA-MRSA strains are notable for their ability to spread in closed settings and cause recurrent infections among healthy persons. Management of recurrent CA-MRSA infection is challenging and optimal prevention strategies are undefined. Many experts recommend topical agents that decontaminate the body and/or anterior nares. However, there are no data that quantify the efficacy and safety of this approach.
We conducted a prospective non-comparative clinical trial to quantify the efficacy and safety of body decolonization regimens in the prevention of CA-MRSA infection from an Infectious Diseases private practice group in Northern California.
The study population comprised of persons suffering from recurrent CA-MRSA infection. For this clinical trial, all subjects will be given: nasal mupirocin (Bactroban Nasal, twice daily), topical 3% hexachlorophene body wash (Phisohex, daily), and an oral anti-MRSA antibiotic. The choice of oral antibiotic was based on investigators choice and antibiotic susceptibility of prior MRSA isolates in a given patient.
Patients were interviewed in person baseline and by phone at 2 weeks, 3 months, and 6 months using a standardized questionnaire. The baseline survey, based on a previously developed instrument used for an epidemiologic investigation of MRSA asked about MRSA risk factors and health-related quality of life. Follow up surveys asked about adverse drug effects, especially gastrointestinal and dermatologic side effects (2 week visit only) and incident skin and MRSA infections.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nasal, body, and systemic decolonization | Experimental | Drug: nasal mupirocin, Drug: topical 3% hexachlorophene body wash, Drug: oral anti-MRSA antibiotic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| nasal mupirocinAlso: Bactrban Nasaltwice daily for 10 days | Drug | Nasal, body, and systemic decolonization |
| topical 3% hexachlorophene body washAlso: Phisohexdaily for 10 days | Drug | Nasal, body, and systemic decolonization |
| oral anti-MRSA antibioticAlso: trimethoprim-sulfamethoxazole, doxycycline, minocyclineThe choice of oral antibiotic was based on investigators choice and antibiotic susceptibility of prior MRSA isolates in a given patient | Drug | Nasal, body, and systemic decolonization |
Primary outcome
A new MRSA or skin infection consistent with MRSA infection.
Time frame: 6 months
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 14 Jan 2010.
Related trials for Methicillin Resistant Staphylococcus Aureus Skin Infections
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Trimethoprim-sulfamethoxazole vs. Clindamycin for the Treatment of Children With Invasive MRSA Infections
Methicillin Resistant Staphylococcus Aureus, Osteomyelitis Acute
Active, not recruitingObservational study
Comparative Analysis of Nemonoxacin and Other Anti-methicillin Resistant Staphylococcus Aureus (Anti-MRSA) Antimicrobial Therapy in Patients With Complicated Skin and Soft Tissue Infections (cSSTI): a Retrospective Chart Review Study
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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.
Allen Radner, M.D. principal investigator
Navidad Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing nasal mupirocin, topical 3% hexachlorophene body wash and oral anti-MRSA antibiotic in people with Methicillin Resistant Staphylococcus Aureus Skin Infections, run by Natividad Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 14 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
A new MRSA or skin infection consistent with MRSA infection. (time frame: 6 months). 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 14 Jan 2010.