HIV InfectionsMRSANCT00631566

Prospective Study of Methicillin-Resistant Staphylococcus Aureus (MRSA) Among HIV-Infected Persons

A study testing Mupirocin (Bactroban) 2%; hexachlorophene (pHisoHex) 3% in people with HIV Infections and Staphylococcal Infections, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV Infections, Staphylococcal Infections
What is being tested?: Mupirocin (Bactroban) 2%; hexachlorophene (pHisoHex) 3%
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 550 participants
Where: 4 sitesUnited States
Study dates: May 2007to Oct 2017
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adults (at least 18 years of age) who are HIV positive by a reactive screening (ELISA, EIA) and a confirmatory test (Western blot) and who are able to attend the study visits which are every 6 months (+/- 2 months), at the minimum

Who cannot join

Known allergy to mupirocin (Bactroban®) nasal ointment or hexachlorophene (pHisoHex®) soaps or constituents of these products.
Age less than 18 years.
Inability to remain in the study for the two year duration.
Pregnant or breastfeeding females.
Females who intend to become pregnant during the two year study time period.
Persons who are healthcare providers with direct patient contact.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
Naval Medical Center Portsmouth
Portsmouth, Virginia, 23708-2197
San Antonio Military Medical Center (BAMC/WHMC)
San Antonio, Texas, 78236-9908
Naval Medical Center San Diego/Infectious Disease Division
San Diego, California, 92134-1201

Other trials in United States

About this study

Official title: Prospective Study on the Incidence, Predictors, and Characteristics of Methicillin-Resistant Staphylococcus Aureus Infections and a Randomized, Double-Blind Study on Decolonization Procedures for Prevention of MRSA Infections Among HIV-Infected Persons

This study will prospectively evaluate the prevalence and incidence (over a two year period) of MRSA colonization and infection among HIV-infected military beneficiaries to determine predictors for the development of MRSA colonization and infection. This study will also investigate the utility of decolonization procedures for clearance of MRSA carriage and prevention of MRSA infections. Finally, the molecular characteristics and the antimicrobial sensitivities of isolates in this population will be determined.

Conditions: HIV Infections, Staphylococcal Infections
Being tested: Mupirocin (Bactroban) 2%; hexachlorophene (pHisoHex) 3%, Placebo
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.

Mupirocin (Bactroban) 2%; hexachlorophene (pHisoHex) 3%Drug
BACTROBAN NASAL is a white to off-white ointment that contains 2.15% w/w mupirocin calcium (equivalent to 2.0% pure mupirocin free acid) in a soft white ointment base. The inactive ingredients are paraffin and a mixture of glycerin esters (SOFTISAN 649).
pHisoHex, brand of hexachlorophene detergent cleanser, is an antibacterial sudsing emulsion for topical administration.
Some randomized patients will receive mupirocin (Bactroban) nasal ointment plus hexachlorophene (pHisoHex) body washes for seven days.
PlaceboDrug
Some randomized patients will receive a placebo nasal ointment (white petroleum) and a placebo body soap with no antimicrobial activity for seven days.

Study groups in NCT00631566
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: Mupirocin (Bactroban) 2%; hexachlorophene (pHisoHex) 3%
2	Placebo comparator	Not described Receives: Drug: Placebo
No MRSA colonization	No intervention	Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

The Presence of MRSA on Repeated Swabs to Assess the Efficacy of These Medications on Clearing MRSA Colonization
MRSA colonization at 6-months post-randomization
Measured: 6 months

Secondary outcomes (3)

To Determine the Prevalence and Incidence of MRSA Colonization of the Nares, Throat, Perirectal, Axilla, and Groin Areas Among HIV Infected Patients and to Study Changes in the Colonization Rates Over Time.
Measured: Every 6 months
To Evaluate the Change in CD4 Counts and HIV Viral Loads During the Time of a MRSA or Soft Tissue Infection.
This outcome measure was not analyzed/reported due to resource limitations.
Measured: At time of infection
To Characterize the Molecular Characteristics and the Antimicrobial Sensitivities of MRSA Isolates in This Population.
This outcome measure was not analyzed/reported due to resource limitation.
Measured: at time of positive MRSA results

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2007Oct 2017

First posted7 Mar 2008 (estimated)
Study startMay 2007
Primary completionMay 2017
Study completionOct 2017

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 (4)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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 550 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00631566
Sponsor's protocol ID: IDCRP-003-RV210
Acronym: MRSA
Status last verified: Mar 2023
First submitted: 27 Feb 2008
Last updated: 3 Mar 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Vyas KJ, Shadyab AH, Lin CD, Crum-Cianflone NF. Trends and factors associated with initial and recurrent methicillin-resistant Staphylococcus aureus (MRSA) skin and soft-tissue infections among HIV-infected persons: an 18-year study. J Int Assoc Provid AIDS Care. 2014 May-Jun;13(3):206-13. doi: 10.1177/2325957412473780. Epub 2013 Apr 19.
PubMed 23603632
Crum-Cianflone NF, Shadyab AH, Weintrob A, Hospenthal DR, Lalani T, Collins G, Mask A, Mende K, Brodine SK, Agan BK; Infectious Disease Clinical Research Program HIV Working Group. Association of methicillin-resistant Staphylococcus aureus (MRSA) colonization with high-risk sexual behaviors in persons infected with human immunodeficiency virus (HIV). Medicine (Baltimore). 2011 Nov;90(6):379-389. doi: 10.1097/MD.0b013e318238dc2c.
PubMed 22033452
Weintrob A, Bebu I, Agan B, Diem A, Johnson E, Lalani T, Wang X, Bavaro M, Ellis M, Mende K, Crum-Cianflone N. Randomized, Double-Blind, Placebo-Controlled Study on Decolonization Procedures for Methicillin-Resistant Staphylococcus aureus (MRSA) among HIV-Infected Adults. PLoS One. 2015 May 27;10(5):e0128071. doi: 10.1371/journal.pone.0128071. eCollection 2015.
PubMed 26018036
Crum-Cianflone NF, Wang X, Weintrob A, Lalani T, Bavaro M, Okulicz JF, Mende K, Ellis M, Agan BK. Specific Behaviors Predict Staphylococcus aureus Colonization and Skin and Soft Tissue Infections Among Human Immunodeficiency Virus-Infected Persons. Open Forum Infect Dis. 2015 Mar 6;2(2):ofv034. doi: 10.1093/ofid/ofv034. eCollection 2015 Apr.
PubMed 26380335

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective Study on the Incidence, Predictors, and Characteristics of Methicillin-Resistant Staphylococcus Aureus Infections and a Randomized, Double-Blind Study on Decolonization Procedures for Prevention of MRSA Infections Among HIV-Infected Persons
ClinicalTrials.gov ID: NCT00631566
Acronym / sponsor ID: MRSA / IDCRP-003-RV210
Conditions: HIV Infections, Staphylococcal Infections
Keywords: HIV, Methicillin-resistant Staphylococcus aureus (MRSA), HIV and Staphylococcus aureus infection
Study type: Interventional
Recruitment status: Completed
Enrolment: 550 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), US Military HIV Research Program
Study start: May 2007
Primary completion: May 2017 (actual)
Study completion: Oct 2017 (actual)
First posted: 7 Mar 2008 (estimated)
Results: Posted 16 Aug 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
1	Experimental	Drug: Mupirocin (Bactroban) 2%; hexachlorophene (pHisoHex) 3%
2	Placebo comparator	Drug: Placebo
No MRSA colonization	No intervention	–

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Adults (at least 18 years of age) who are HIV positive by a reactive screening (ELISA, EIA) and a confirmatory test (Western blot) and who are able to attend the study visits which are every 6 months (+/- 2 months), at the minimum

Key exclusion criteria (6 listed)

Known allergy to mupirocin (Bactroban®) nasal ointment or hexachlorophene (pHisoHex®) soaps or constituents of these products.
Age less than 18 years.
Inability to remain in the study for the two year duration.
Pregnant or breastfeeding females.
Females who intend to become pregnant during the two year study time period.

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 (Bactroban) 2%; hexachlorophene (pHisoHex) 3%BACTROBAN NASAL is a white to off-white ointment that contains 2.15% w/w mupirocin calcium (equivalent to 2.0% pure mupirocin free acid) in a soft white ointment base. The inactive ingredients are paraffin and a mixture of glycerin esters (SOFTISAN 649). pHisoHex, brand of hexachlorophene detergent cleanser, is an antibacterial sudsing emulsion for topical administration. Some randomized patients will receive mupirocin (Bactroban) nasal ointment plus hexachlorophene (pHisoHex) body washes for seven days.	Drug	1
PlaceboSome randomized patients will receive a placebo nasal ointment (white petroleum) and a placebo body soap with no antimicrobial activity for seven days.	Drug	2

Primary outcome

The Presence of MRSA on Repeated Swabs to Assess the Efficacy of These Medications on Clearing MRSA Colonization
Time frame: 6 months
MRSA colonization at 6-months post-randomization

3 secondary outcomes

To Determine the Prevalence and Incidence of MRSA Colonization of the Nares, Throat, Perirectal, Axilla, and Groin Areas Among HIV Infected Patients and to Study Changes in the Colonization Rates Over Time.
Time frame: Every 6 months
To Evaluate the Change in CD4 Counts and HIV Viral Loads During the Time of a MRSA or Soft Tissue Infection.
Time frame: At time of infection
To Characterize the Molecular Characteristics and the Antimicrobial Sensitivities of MRSA Isolates in This Population.
Time frame: at time of positive MRSA results

Results and safety

Results posted to the registry on 16 Aug 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Mupirocin/Hexachlorophene Group	21	19
Placebo Group	28	24
No MRSA Colonization	501	501

Primary outcome: The Presence of MRSA on Repeated Swabs to Assess the Efficacy of These Medications on Clearing MRSA Colonization

Time frame: 6 months. Count of participants. Unit: Participants

Measure	Mupirocin/Hexachlorophene Group n = 18	Placebo Group n = 21	No MRSA Colonization n = 501
Value	12	14	0

Population analysed: Only 80% of the 49 initial randomizations had 6-month colonization data and were analyzed.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 2 years following enrollment into the study. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mupirocin/Hexachlorophene Group	1 of 21 (4.8%)	0 of 21 (0%)	0 of 21
Placebo Group	0 of 28 (0%)	0 of 28 (0%)	0 of 28
No MRSA Colonization	0 of 501 (0%)	0 of 501 (0%)	0 of 501

Limitations and caveats (from the sponsor): Low rates of MRSA infections and SSTI during follow-up. Mostly males. Data for counts by arm other than nares for Outcome #2 are estimates from proportions and overall sample as these data were not available when record completed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 23603632Vyas KJ, Shadyab AH, Lin CD, Crum-Cianflone NF. Trends and factors associated with initial and recurrent methicillin-resistant Staphylococcus aureus (MRSA) skin and soft-tissue infections among HIV-infected persons: an 18-year study. J Int Assoc Provid AIDS Care. 2014 May-Jun;13(3):206-13. doi: 10.1177/2325957412473780. Epub 2013 Apr 19.
Results publication: PubMed 22033452Crum-Cianflone NF, Shadyab AH, Weintrob A, Hospenthal DR, Lalani T, Collins G, Mask A, Mende K, Brodine SK, Agan BK; Infectious Disease Clinical Research Program HIV Working Group. Association of methicillin-resistant Staphylococcus aureus (MRSA) colonization with high-risk sexual behaviors in persons infected with human immunodeficiency virus (HIV). Medicine (Baltimore). 2011 Nov;90(6):379-389. doi: 10.1097/MD.0b013e318238dc2c.
Results publication: PubMed 26018036Weintrob A, Bebu I, Agan B, Diem A, Johnson E, Lalani T, Wang X, Bavaro M, Ellis M, Mende K, Crum-Cianflone N. Randomized, Double-Blind, Placebo-Controlled Study on Decolonization Procedures for Methicillin-Resistant Staphylococcus aureus (MRSA) among HIV-Infected Adults. PLoS One. 2015 May 27;10(5):e0128071. doi: 10.1371/journal.pone.0128071. eCollection 2015.
Results publication: PubMed 26380335Crum-Cianflone NF, Wang X, Weintrob A, Lalani T, Bavaro M, Okulicz JF, Mende K, Ellis M, Agan BK. Specific Behaviors Predict Staphylococcus aureus Colonization and Skin and Soft Tissue Infections Among Human Immunodeficiency Virus-Infected Persons. Open Forum Infect Dis. 2015 Mar 6;2(2):ofv034. doi: 10.1093/ofid/ofv034. eCollection 2015 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.

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 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 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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. Some participants in this study may receive a placebo. 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 16 Aug 2018). 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?

The Presence of MRSA on Repeated Swabs to Assess the Efficacy of These Medications on Clearing MRSA Colonization (time frame: 6 months). 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 NCT00631566, which also lists 4 linked publications.

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 3 Mar 2023; AzTrials last refreshed its copy on 6 Nov 2026.