HIV InfectionsMRSA-2NCT00859677
Immunologic Predisposition of HIV Patients to Develop Methicillin-Resistant Staphylococcus Aureus (MRSA) Colonization and Infection
An observational study of HIV Infections and Staphylococcal Infections, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 2 sites in United States.
Trial summary
The purpose of this study is to investigate the role of T helper 17 cells (Th17) in the pathogenesis of MRSA infections. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Staphylococcal Infections
- How many people
- 52 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2009to 26 Aug 2016
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: HIV-positive and negative patients with a recent screen for MRSA colonization or a history of MRSA infection will be asked to participate. Participants will be recruited by providers within the infectious disease clinics at the sites. In addtion, MRSA isolates will be monitored at the central laboratory and providers of patients with MRSA will be notified and asked to notify their patients of the opportunity to participate in this study.
Who may be able to join
None listed.
Who cannot join
- Women with positive urine pregnancy test within 7 days of study enrollment
- Women who are within 6 months of being postpartum or who are currently breastfeeding
- Subjects unable or unwilling to complete questionnaires and blood draw.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
Naval Medical Center San Diego
San Diego, California, 92134
About this study
The purpose of this study is to investigate the role of T helper 17 cells (Th17) in the pathogenesis of MRSA infections.
- Conditions
- HIV Infections, Staphylococcal Infections
- Keywords
- HIV, Methicillin-resistant Staphylococcus aureus (MRSA), HIV and Staphylococcus aureus infection
- Medical subject headings
- HIV Infections, Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | HIV-positive and MRSA negative | |
| 2 | HIV-positive and MRSA infected (skin/soft tissue) | |
| 3 | HIV-positive and MRSA colonized | |
| 4 | HIV-negative and MRSA negative | |
| 5 | HIV-negative and MRSA infected (skin/soft tissue) | |
| 6 | HIV-negative and MRSA colonized |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare distribution of Th17 cells and their functionality, in the peripheral blood of HIV-positive patients who are infected with MRSA with that of HIV-positive patients who are not colonized or infected with Staphylococcus aureus.
Measured: 1 year
Secondary outcomes (4)
Compare distribution of Th17 cells in the peripheral blood of groups of HIV-positive and HIV-negative participants who are colonized with MRSA as well as those who have a MRSA infection.
Measured: 1 year
Examine distribution of T cells, B cells, macrophages, dendritic cells, neutrophils, defensins, and IL-17 in T cell subsets in the skin
Measured: 1 year
Compare Th17 cells in peripheral blood of HIV-negative participants with MRSA infection with that of HIV-negative subjects not colonized of infected with Staph aureus.
Measured: 1 year
Collect information on factors that may play a role in development of MRSA colonization/infection. Includes demographic, hygienic, exercise-related, and sexual factors which may contribute to MRSA.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionNov 2010
- Study completion26 Aug 2016
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 HIV 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Infectious Diseases Clinical Research Program, National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00859677
- Sponsor's protocol ID
- IDCRP -023
- Acronym
- MRSA-2
- Status last verified
- Feb 2023
- First submitted
- 10 Mar 2009
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Utay NS, Roque A, Timmer JK, Morcock DR, DeLeage C, Somasunderam A, Weintrob AC, Agan BK, Estes JD, Crum-Cianflone NF, Douek DC. MRSA Infections in HIV-Infected People Are Associated with Decreased MRSA-Specific Th1 Immunity. PLoS Pathog. 2016 Apr 19;12(4):e1005580. doi: 10.1371/journal.ppat.1005580. eCollection 2016 Apr.
PubMed 27093273
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunologic Predisposition of HIV Patients to Develop Methicillin-Resistant Staphylococcus Aureus (MRSA) Colonization and Infection
- ClinicalTrials.gov ID
- NCT00859677
- Acronym / sponsor ID
- MRSA-2 / IDCRP -023
- Conditions
- HIV Infections, Staphylococcal Infections
- Keywords
- HIV, Methicillin-resistant Staphylococcus aureus (MRSA), HIV and Staphylococcus aureus infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military MedicineUniversity, hospital or other
- Collaborators
- Infectious Diseases Clinical Research Program, National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Mar 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- 26 Aug 2016 (actual)
- First posted
- 11 Mar 2009 (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 purpose of this study is to investigate the role of T helper 17 cells (Th17) in the pathogenesis of MRSA infections.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –HIV-positive and MRSA negative |
| 2 | – | –HIV-positive and MRSA infected (skin/soft tissue) |
| 3 | – | –HIV-positive and MRSA colonized |
| 4 | – | –HIV-negative and MRSA negative |
| 5 | – | –HIV-negative and MRSA infected (skin/soft tissue) |
| 6 | – | –HIV-negative and MRSA colonized |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- HIV-positive and negative patients with a recent screen for MRSA colonization or a history of MRSA infection will be asked to participate. Participants will be recruited by providers within the infectious disease clinics at the sites. In addtion, MRSA isolates will be monitored at the central laboratory and providers of patients with MRSA will be notified and asked to notify their patients of the opportunity to participate in this study.
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Women with positive urine pregnancy test within 7 days of study enrollment
- Women who are within 6 months of being postpartum or who are currently breastfeeding
- Subjects unable or unwilling to complete questionnaires and blood draw.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To compare distribution of Th17 cells and their functionality, in the peripheral blood of HIV-positive patients who are infected with MRSA with that of HIV-positive patients who are not colonized or infected with Staphylococcus aureus.
Time frame: 1 year
4 secondary outcomes
Compare distribution of Th17 cells in the peripheral blood of groups of HIV-positive and HIV-negative participants who are colonized with MRSA as well as those who have a MRSA infection.
Time frame: 1 year
Examine distribution of T cells, B cells, macrophages, dendritic cells, neutrophils, defensins, and IL-17 in T cell subsets in the skin
Time frame: 1 year
Compare Th17 cells in peripheral blood of HIV-negative participants with MRSA infection with that of HIV-negative subjects not colonized of infected with Staph aureus.
Time frame: 1 year
Collect information on factors that may play a role in development of MRSA colonization/infection. Includes demographic, hygienic, exercise-related, and sexual factors which may contribute to MRSA.
Time frame: 1 year
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 15 Feb 2023.
- Results publication: PubMed 27093273Utay NS, Roque A, Timmer JK, Morcock DR, DeLeage C, Somasunderam A, Weintrob AC, Agan BK, Estes JD, Crum-Cianflone NF, Douek DC. MRSA Infections in HIV-Infected People Are Associated with Decreased MRSA-Specific Th1 Immunity. PLoS Pathog. 2016 Apr 19;12(4):e1005580. doi: 10.1371/journal.ppat.1005580. eCollection 2016 Apr.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and Staphylococcal Infections, run by Henry M. Jackson Foundation for the Advancement of Military 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 0 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 15 Feb 2023. 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?
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?
To compare distribution of Th17 cells and their functionality, in the peripheral blood of HIV-positive patients who are infected with MRSA with that of HIV-positive patients who are not colonized or infected with Staphylococcus aureus. (time frame: 1 year). 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 NCT00859677, 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 15 Feb 2023.