Methicillin-Resistant Staphylococcus AureusPhase 4CAMP-2NCT02566928
Patient-Centered Comparative Effectiveness Research (CER) Study of Home-based Interventions to Prevent CA-MRSA Infection Recurrence
A Phase 4 study testing 2% mupirocin ointment, Chlorhexidine wash and Hygiene protocol in people with Methicillin-Resistant Staphylococcus Aureus and Recurrence, run by Clinical Directors Network at 6 sites in United States.
Trial summary
The overall goal of the project is to develop and evaluate a home-based intervention to prevent re-infection and transmission of Community-Acquired Methicillin-resistant Staphylococcus aureus (CA-MRSA) in patients presenting to primary care with skin or soft tissue infections (SSTIs). Read more about this study
- Who is it for?
- Ages 7 to 70 years
- Conditions the study is for
- Methicillin-Resistant Staphylococcus Aureus, Recurrence, Staphylococcal Skin Infections
- What is being tested?
- 2% mupirocin ointment, Chlorhexidine wash and Hygiene protocol
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 278 participants
- Where
- 6 sitesUnited States
- Study dates
- Oct 2015to 31 Dec 2018
- Phase
- Phase 4
- 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 7 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- between 7 to 70 years of age
- fluent in English or Spanish
- plans to receive care in the Community Health Center during the next year
- presents with signs and symptoms of a SSTI
- willing/able to provide informed consent
Who cannot join
- The patient is unwilling to provide informed consent
- acutely sick (for example, crying, wheezing, bleeding, screaming or shaken)
- unable to participate in a discussion about the study
Trial locations and contacts
6 sites in 1 country.
Jonathan N Tobin, PhD contact
Chamanara Khalida, MD, MPH contact
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
NYU Lutheran Family Health Centers
Brooklyn, New York, 11220
William Pagano, MD, MPH
- Recruiting
NYU Lutheran Medical Center Emergency Department
Brooklyn, New York, 11220
Paula Clemons, PA
- Recruiting
Coney Island Hospital
Brooklyn, New York, 11235
Regina Hammock, DO
- Recruiting
Community Healthcare Network
New York, New York, 10010
Satoko Kanahara, MD
- Recruiting
Metropolitan Hospital Center
New York, New York, 10029
Getaw Worku Hassen, MD
- Recruiting
Urban Health Plan
The Bronx, New York, 10459
Tracie Urban, RN, BSN
About this study
The overall goal of the project is to develop and evaluate a home-based intervention to prevent re-infection and transmission of Community-Acquired Methicillin-resistant Staphylococcus aureus (CA-MRSA) in patients presenting to primary care with skin or soft tissue infections (SSTIs). Centers for Disease Control (CDC) CA-MRSA guidelines include incision and drainage, antibiotic sensitivity testing and antibiogram-directed prescribing. Re-infections are common, ranging from 16% to 43%, and present significant challenges to clinicians, patients and their families. Several decolonization and decontamination interventions have been shown to reduce Hospital-Acquired MRSA (HA-MRSA) re-infection and transmission in intensive care units. Few studies examine the feasibility and effectiveness of these infection prevention interventions into primary care settings, and none employ Community Health Workers (CHWs) or "promotoras" to provide home visits for education and interventions about decolonization and decontamination. This comparative effectiveness research/patient centered outcomes research builds upon a highly stakeholder-engaged community-academic research and learning collaborative, including practicing clinicians, patients, clinical and laboratory researchers, and barbers/beauticians. Clinical Directors Network (CDN), an established, NIH-recognized best practice Federally Qualified Health Center (FQHC) Practice-based Research Network (PBRN), and The Rockefeller University propose to address this question through the completion of four aims: (1) To evaluate the comparative effectiveness of a CHW/Promotora-delivered home intervention (Experimental Group) as compared to Usual Care (Control Group) on the primary patient-centered and clinical outcome (SSTI recurrence rates) and secondary patient-centered and clinical outcomes (pain, depression, quality of life, care satisfaction) using a two-arm randomized controlled trial (RCT). (2) To understand the patient-level factors (CA-MRSA infection prevention knowledge, self-efficacy, decision-making autonomy, prevention behaviors/adherence) and environmental-level factors (household surface contamination, household member colonization, transmission to household members) that are associated with differences in SSTI recurrence rates. (3) To understand interactions of the intervention with bacterial genotypic and phenotypic variables on decontamination, decolonization, SSTI recurrence, and household transmission. (4) To explore the evolution of stakeholder engagement and interactions among patients and other community stakeholders with practicing community-based clinicians and academic laboratory and clinical investigators over the duration of the study period.
- Conditions
- Methicillin-Resistant Staphylococcus Aureus, Recurrence, Staphylococcal Skin Infections, Antibiotic Resistance
- Being tested
- 2% mupirocin ointment, Chlorhexidine wash, Hygiene protocol
- Keywords
- Methicillin-Resistant Staphylococcus aureus, Recurrence, Practice Based Research Network, Community Health Workers/Promotoras, Decolonization and Decontamination, Staphylococcal Skin Infections, Household Transmission
- Medical subject headings
- Recurrence, Staphylococcal Skin 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 Bacitracin, Bactroban
Index patients and consenting household members will complete a decolonization regimen consisting of twice-daily application of mupirocin ointment to the anterior nares with a sterile cotton applicator for five days.
Chlorhexidine washOther
Also called Hibiclens
Index patients and consenting household members will daily daily for five days with chlorhexidine wash.
Hygiene protocolBehavioural
Index patients and consenting household members will be given educational materials and instructed to in the use of hand-washing, surface disinfection, and laundering.
| Study group | Role | What they receive |
|---|---|---|
| Decolonization and Decontamination | Experimental | Index Patients will receive: 1) guidelines-directed care, which may consist of incision, drainage, oral antibiotics, and antibiogram-based antibiotic prescribing, and 2) a home-based intervention implemented by Community Health Workers/Promotoras that includes index patient and household member education and instructions to complete a decolonization and decontamination regimen, along with printed materials describing a standard hygiene protocol for reducing household contamination. Index patients and consenting household members will complete a decolonization regimen consisting of twice-daily application of 2% mupirocin ointment to the anterior nares with a clean cotton applicator for five days, as well as daily bathing with chlorhexidine wash for five days. The household decontamination hygiene protocol includes the use of hand-washing, surface disinfection, and laundering. Receives: Drug: 2% mupirocin ointment; Other: Chlorhexidine wash; Behavioral: Hygiene protocol |
| Usual Care | No intervention | Index Patients will receive: 1) guidelines-directed care, which may consist of incision, drainage, and oral antibiotics, as well as antibiogram-based antibiotic prescribing, and 2) printed materials describing a standard hygiene protocol for reducing household contamination. |
What is being measured
The primary outcome is the main question the study is designed to answer.
SSTI Recurrence Rate
Defined as having one or more discrete clinical SSTIs at the same or new site in addition to the baseline infection. Defined by self-report and review of patients' medical records for evidence of one or more of the following: (1) new SSTIs for which the patient presents for medical care, (2) the initial SSTI which failed to heal despite treatment (including I\&D and/or antibiotic prescription), (3) a new laboratory-confirmed culture of MRSA or Methicillin Sensitive Staphylococcus aureus (MSSA).
Measured: 3 months
SSTI Recurrence Rate
Defined as having one or more discrete clinical SSTIs at the same or new site in addition to the baseline infection. Defined by self-report and review of patients' medical records for evidence of one or more of the following: (1) new SSTIs for which the patient presents for medical care, (2) the initial SSTI which failed to heal despite treatment (including I\&D and/or antibiotic prescription), (3) a new laboratory-confirmed culture of MRSA or Methicillin Sensitive Staphylococcus aureus (MSSA).
Measured: 6 months
SSTI Recurrence Rate
Defined as having one or more discrete clinical SSTIs at the same or new site in addition to the baseline infection. Defined by self-report and review of patients' medical records for evidence of one or more of the following: (1) new SSTIs for which the patient presents for medical care, (2) the initial SSTI which failed to heal despite treatment (including I\&D and/or antibiotic prescription), (3) a new laboratory-confirmed culture of MRSA or Methicillin Sensitive Staphylococcus aureus (MSSA).
Measured: 12 months
Secondary outcomes (11)
Clinical Response Questionnaire
Measured: 1, 3, 6, and 12 months
Subsequent SSTI Self-Report
Measured: 1, 3, 6, and 12 months
Medication Adherence Scale
Measured: 1, 3, 6, and 12 months
Satisfaction with Participating in Social Roles
Measured: Baseline, 3, 6, and 12 months
Depression Short Form
Measured: Baseline, 3, 6, and 12 months
Pain Interference Short Form
Measured: Baseline, 3, 6, and 12 months
Short Form 36 Health Survey
Measured: Baseline, 3, 6, and 12 months
Hygiene Score
Measured: Baseline, 1, 3, 6, and 12 months
Household Crowding Index
Measured: Baseline and 3 months
Number of participants with adverse events
Measured: Baseline, 1, 3, 6, and 12 months
Incidence of Mupirocin Resistance
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionNov 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
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 Methicillin-Resistant Staphylococcus AureusStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 278 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinical Directors Network
- Sponsor type
- Research network
- Collaborators
- Rockefeller University, Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Jonathan N Tobin, PhD, Principal investigator, Clinical Directors Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02566928
- Sponsor's protocol ID
- CER-1402-10800
- Acronym
- CAMP-2
- Status last verified
- Jul 2017
- First submitted
- 30 Sep 2015
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
D'Orazio B, Ramachandran J, Khalida C, Gonzalez J, Kost RG, Vasquez KS, Evering TH, Holder T, Hassen GW, Hammock R, Nguyen R, Davis R, Millan K, Johnson V, Parola C, Coller BS, Tobin JN. Stakeholder Engagement In a Comparative Effectiveness/Implementation Study to Prevent Staphylococcus Aureus Infection Recurrence: CA-MRSA Project (CAMP2). Prog Community Health Partnersh. 2022;16(1):45-60. doi: 10.1353/cpr.2022.0005.
PubMed 35342110
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Centered Comparative Effectiveness Research (CER) Study of Home-based Interventions to Prevent CA-MRSA Infection Recurrence
- ClinicalTrials.gov ID
- NCT02566928
- Acronym / sponsor ID
- CAMP-2 / CER-1402-10800
- Conditions
- Methicillin-Resistant Staphylococcus Aureus, Recurrence, Staphylococcal Skin Infections, Antibiotic Resistance
- Keywords
- Methicillin-Resistant Staphylococcus aureus, Recurrence, Practice Based Research Network, Community Health Workers/Promotoras, Decolonization and Decontamination, Staphylococcal Skin Infections, Household Transmission
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 278 participants (estimated)
- Lead sponsor
- Clinical Directors NetworkResearch network
- Collaborators
- Rockefeller University, Patient-Centered Outcomes Research Institute
- Study start
- Oct 2015
- Primary completion
- Nov 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 2 Oct 2015 (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.
The overall goal of the project is to develop and evaluate a home-based intervention to prevent re-infection and transmission of Community-Acquired Methicillin-resistant Staphylococcus aureus (CA-MRSA) in patients presenting to primary care with skin or soft tissue infections (SSTIs). Centers for Disease Control (CDC) CA-MRSA guidelines include incision and drainage, antibiotic sensitivity testing and antibiogram-directed prescribing. Re-infections are common, ranging from 16% to 43%, and present significant challenges to clinicians, patients and their families. Several decolonization and decontamination interventions have been shown to reduce Hospital-Acquired MRSA (HA-MRSA) re-infection and transmission in intensive care units. Few studies examine the feasibility and effectiveness of these infection prevention interventions into primary care settings, and none employ Community Health Workers (CHWs) or "promotoras" to provide home visits for education and interventions about decolonization and decontamination. This comparative effectiveness research/patient centered outcomes research builds upon a highly stakeholder-engaged community-academic research and learning collaborative, including practicing clinicians, patients, clinical and laboratory researchers, and barbers/beauticians. Clinical Directors Network (CDN), an established, NIH-recognized best practice Federally Qualified Health Center (FQHC) Practice-based Research Network (PBRN), and The Rockefeller University propose to address this question through the completion of four aims: (1) To evaluate the comparative effectiveness of a CHW/Promotora-delivered home intervention (Experimental Group) as compared to Usual Care (Control Group) on the primary patient-centered and clinical outcome (SSTI recurrence rates) and secondary patient-centered and clinical outcomes (pain, depression, quality of life, care satisfaction) using a two-arm randomized controlled trial (RCT). (2) To understand the patient-level factors (CA-MRSA infection prevention knowledge, self-efficacy, decision-making autonomy, prevention behaviors/adherence) and environmental-level factors (household surface contamination, household member colonization, transmission to household members) that are associated with differences in SSTI recurrence rates. (3) To understand interactions of the intervention with bacterial genotypic and phenotypic variables on decontamination, decolonization, SSTI recurrence, and household transmission. (4) To explore the evolution of stakeholder engagement and interactions among patients and other community stakeholders with practicing community-based clinicians and academic laboratory and clinical investigators over the duration of the study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decolonization and Decontamination | Experimental | Drug: 2% mupirocin ointment, Other: Chlorhexidine wash, Behavioral: Hygiene protocolIndex Patients will receive: 1) guidelines-directed care, which may consist of incision, drainage, oral antibiotics, and antibiogram-based antibiotic prescribing, and 2) a home-based intervention implemented by Community Health Workers/Promotoras that includes index patient and household member education and instructions to complete a decolonization and decontamination regimen, along with printed materials describing a standard hygiene protocol for reducing household contamination. Index patients and consenting household members will complete a decolonization regimen consisting of twice-daily application of 2% mupirocin ointment to the anterior nares with a clean cotton applicator for five days, as well as daily bathing with chlorhexidine wash for five days. The household decontamination hygiene protocol includes the use of hand-washing, surface disinfection, and laundering. |
| Usual Care | No intervention | –Index Patients will receive: 1) guidelines-directed care, which may consist of incision, drainage, and oral antibiotics, as well as antibiogram-based antibiotic prescribing, and 2) printed materials describing a standard hygiene protocol for reducing household contamination. |
Who may qualify
- Ages
- 7 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- between 7 to 70 years of age
- fluent in English or Spanish
- plans to receive care in the Community Health Center during the next year
- presents with signs and symptoms of a SSTI
- willing/able to provide informed consent
Key exclusion criteria (3 listed)
- The patient is unwilling to provide informed consent
- acutely sick (for example, crying, wheezing, bleeding, screaming or shaken)
- unable to participate in a discussion about the study
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: Bacitracin, BactrobanIndex patients and consenting household members will complete a decolonization regimen consisting of twice-daily application of mupirocin ointment to the anterior nares with a sterile cotton applicator for five days. | Drug | Decolonization and Decontamination |
| Chlorhexidine washAlso: HibiclensIndex patients and consenting household members will daily daily for five days with chlorhexidine wash. | Other | Decolonization and Decontamination |
| Hygiene protocolIndex patients and consenting household members will be given educational materials and instructed to in the use of hand-washing, surface disinfection, and laundering. | Behavioural | Decolonization and Decontamination |
Primary outcome
SSTI Recurrence Rate
Time frame: 3 months
Defined as having one or more discrete clinical SSTIs at the same or new site in addition to the baseline infection. Defined by self-report and review of patients' medical records for evidence of one or more of the following: (1) new SSTIs for which the patient presents for medical care, (2) the initial SSTI which failed to heal despite treatment (including I\&D and/or antibiotic prescription), (3) a new laboratory-confirmed culture of MRSA or Methicillin Sensitive Staphylococcus aureus (MSSA).
SSTI Recurrence Rate
Time frame: 6 months
Defined as having one or more discrete clinical SSTIs at the same or new site in addition to the baseline infection. Defined by self-report and review of patients' medical records for evidence of one or more of the following: (1) new SSTIs for which the patient presents for medical care, (2) the initial SSTI which failed to heal despite treatment (including I\&D and/or antibiotic prescription), (3) a new laboratory-confirmed culture of MRSA or Methicillin Sensitive Staphylococcus aureus (MSSA).
SSTI Recurrence Rate
Time frame: 12 months
Defined as having one or more discrete clinical SSTIs at the same or new site in addition to the baseline infection. Defined by self-report and review of patients' medical records for evidence of one or more of the following: (1) new SSTIs for which the patient presents for medical care, (2) the initial SSTI which failed to heal despite treatment (including I\&D and/or antibiotic prescription), (3) a new laboratory-confirmed culture of MRSA or Methicillin Sensitive Staphylococcus aureus (MSSA).
11 secondary outcomes
Clinical Response Questionnaire
Time frame: 1, 3, 6, and 12 months
Subsequent SSTI Self-Report
Time frame: 1, 3, 6, and 12 months
Medication Adherence Scale
Time frame: 1, 3, 6, and 12 months
Satisfaction with Participating in Social Roles
Time frame: Baseline, 3, 6, and 12 months
Depression Short Form
Time frame: Baseline, 3, 6, and 12 months
Pain Interference Short Form
Time frame: Baseline, 3, 6, and 12 months
Short Form 36 Health Survey
Time frame: Baseline, 3, 6, and 12 months
Hygiene Score
Time frame: Baseline, 1, 3, 6, and 12 months
Household Crowding Index
Time frame: Baseline and 3 months
Number of participants with adverse events
Time frame: Baseline, 1, 3, 6, and 12 months
Incidence of Mupirocin Resistance
Time frame: Baseline and 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
- Derived from this study: PubMed 35342110D'Orazio B, Ramachandran J, Khalida C, Gonzalez J, Kost RG, Vasquez KS, Evering TH, Holder T, Hassen GW, Hammock R, Nguyen R, Davis R, Millan K, Johnson V, Parola C, Coller BS, Tobin JN. Stakeholder Engagement In a Comparative Effectiveness/Implementation Study to Prevent Staphylococcus Aureus Infection Recurrence: CA-MRSA Project (CAMP2). Prog Community Health Partnersh. 2022;16(1):45-60. doi: 10.1353/cpr.2022.0005.
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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.
Jonathan N Tobin, PhD contact
Chamanara Khalida, MD, MPH contact
Jonathan N Tobin, PhD principal investigator
Clinical Directors Network
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 2% mupirocin ointment, Chlorhexidine wash and Hygiene protocol in people with Methicillin-Resistant Staphylococcus Aureus and Recurrence, run by Clinical Directors Network at 6 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 5 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 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jonathan N Tobin, PhD (JNTobin@CDNetwork.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SSTI Recurrence Rate (time frame: 3 months). The study lists 3 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 NCT02566928, 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 21 Jul 2017.