HIV Infections, Staphylococcal Infections
Conditions
Keywords
HIV, Methicillin-resistant Staphylococcus aureus (MRSA), HIV and Staphylococcus aureus infection
Brief summary
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.
Interventions
DRUGMupirocin (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.
DRUGPlacebo
Some randomized patients will receive a placebo nasal ointment (white petroleum) and a placebo body soap with no antimicrobial activity for seven days.
Sponsors
Infectious Diseases Clinical Research Program
National Institute of Allergy and Infectious Diseases (NIAID)
US Military HIV Research Program
Henry M. Jackson Foundation for the Advancement of Military Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Presence of MRSA on Repeated Swabs to Assess the Efficacy of These Medications on Clearing MRSA Colonization | 6 months | MRSA colonization at 6-months post-randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Every 6 months | — |
| To Evaluate the Change in CD4 Counts and HIV Viral Loads During the Time of a MRSA or Soft Tissue Infection. | At time of infection | This outcome measure was not analyzed/reported due to resource limitations. |
| To Characterize the Molecular Characteristics and the Antimicrobial Sensitivities of MRSA Isolates in This Population. | at time of positive MRSA results | This outcome measure was not analyzed/reported due to resource limitation. |
Countries
United States
Participant flow
Recruitment details
HIV-infected adults from four US Military HIV clinics were prospectively enrolled during routine visits. Enrollment occurred between May 2007 and May 2010 and follow-up visits were conducted until August 2012.
Participants by arm
| Arm | Count |
|---|---|
| Mupirocin/Hexachlorophene Group Participants with MRSA colonization who were randomized to receive:
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. | 21 |
| Placebo Group Participants with MRSA colonization who were randomized to receive:
Placebo: Some randomized patients will receive a placebo nasal ointment (white petroleum) and a placebo body soap with no antimicrobial activity for seven days. | 28 |
| No MRSA Colonization Patients who did not have any MRSA colonization. | 501 |
| Total | 550 |
Baseline characteristics
| Characteristic | Total | Mupirocin/Hexachlorophene Group | No MRSA Colonization | Placebo Group |
|---|---|---|---|---|
| Age, Continuous | 42 years | 41 years | 42 years | 46 years |
| CD4 by category 350-499 cells/mm3 | 133 Participants | 4 Participants | 117 Participants | 12 Participants |
| CD4 by category <350 cells/mm3 | 102 Participants | 7 Participants | 93 Participants | 2 Participants |
| CD4 by category >/= 500 cells/mm3 | 314 Participants | 10 Participants | 290 Participants | 14 Participants |
| Current CD4 count | 529 cells/mm3 | 494 cells/mm3 | 534 cells/mm3 | 500 cells/mm3 |
| Race/Ethnicity, Customized African-American | 196 Participants | 10 Participants | 174 Participants | 12 Participants |
| Race/Ethnicity, Customized Caucasian | 311 Participants | 9 Participants | 287 Participants | 15 Participants |
| Race/Ethnicity, Customized Other | 43 Participants | 2 Participants | 40 Participants | 1 Participants |
| Region of Enrollment United States | 550 participants | 21 participants | 501 participants | 28 participants |
| Sex: Female, Male Female | 37 Participants | 1 Participants | 36 Participants | 0 Participants |
| Sex: Female, Male Male | 513 Participants | 20 Participants | 465 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 28 | 0 / 501 |
| other Total, other adverse events | 0 / 21 | 0 / 28 | 0 / 501 |
| serious Total, serious adverse events | 1 / 21 | 0 / 28 | 0 / 501 |
Outcome results
Primary
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
Time frame: 6 months
Population: Only 80% of the 49 initial randomizations had 6-month colonization data and were analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mupirocin/Hexachlorophene Group | The Presence of MRSA on Repeated Swabs to Assess the Efficacy of These Medications on Clearing MRSA Colonization | 12 Participants |
| Placebo Group | The Presence of MRSA on Repeated Swabs to Assess the Efficacy of These Medications on Clearing MRSA Colonization | 14 Participants |
| No MRSA Colonization | The Presence of MRSA on Repeated Swabs to Assess the Efficacy of These Medications on Clearing MRSA Colonization | 0 Participants |
Secondary
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.
Time frame: at time of positive MRSA results
Population: As requested, the number of participants was set to zero since this analysis was not conducted.
Secondary
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
Population: Due to small numbers, the colonization in the sites other than nares, the counts were not further identified between the treatment group and the placebo group.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mupirocin/Hexachlorophene Group | 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. | Groin | NA Participants |
| Mupirocin/Hexachlorophene Group | 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. | Perirectal | NA Participants |
| Mupirocin/Hexachlorophene Group | 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. | Nares | 17 Participants |
| Mupirocin/Hexachlorophene Group | 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. | Throat | NA Participants |
| Mupirocin/Hexachlorophene Group | 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. | Axilla | NA Participants |
| Placebo Group | 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. | Perirectal | NA Participants |
| Placebo Group | 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. | Nares | 18 Participants |
| Placebo Group | 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. | Throat | NA Participants |
| Placebo Group | 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. | Groin | NA Participants |
| Placebo Group | 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. | Axilla | NA Participants |
| No MRSA Colonization | 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. | Axilla | 0 Participants |
| No MRSA Colonization | 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. | Groin | 0 Participants |
| No MRSA Colonization | 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. | Nares | 0 Participants |
| No MRSA Colonization | 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. | Perirectal | 0 Participants |
| No MRSA Colonization | 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. | Throat | 0 Participants |
Secondary
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.
Time frame: At time of infection
Population: As requested, the number of participants was set to zero since this analysis was not conducted.