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| Name | Class |
|---|---|
| Infectious Diseases Clinical Research Program | OTHER |
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
| US Military HIV Research Program | NETWORK |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
| |
| No MRSA colonization | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Naval Medical Center San Diego/Infectious Disease Division | San Diego | California | 92134-1201 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23603632 | Background | 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. | |
| 22033452 |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 2, 2014 |
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|
| Placebo | Drug | Some randomized patients will receive a placebo nasal ointment (white petroleum) and a placebo body soap with no antimicrobial activity for seven days. |
|
This outcome measure was not analyzed/reported due to resource limitations. |
| 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. | at time of positive MRSA results |
| Walter Reed National Military Medical Center |
| Bethesda |
| Maryland |
| 20889 |
| United States |
| San Antonio Military Medical Center (BAMC/WHMC) | San Antonio | Texas | 78236-9908 | United States |
| Naval Medical Center Portsmouth | Portsmouth | Virginia | 23708-2197 | United States |
| 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. |
| 26018036 | Result | 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. |
| 26380335 | Result | 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. |
| FG001 | 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. |
| FG002 | No MRSA Colonization | Patients who did not have any MRSA colonization. |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | No MRSA Colonization | Patients who did not have any MRSA colonization. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Current CD4 count | Median | Inter-Quartile Range | cells/mm3 |
| |||||||||||||||
| CD4 by category | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Only 80% of the 49 initial randomizations had 6-month colonization data and were analyzed. | Posted | Count of Participants | Participants | 6 months |
|
|
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| 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. | 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. | Posted | Count of Participants | Participants | Every 6 months |
| |||||||||||||||||||||||||||||||||||
| 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. | As requested, the number of participants was set to zero since this analysis was not conducted. | Posted | At time of infection |
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| 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. | As requested, the number of participants was set to zero since this analysis was not conducted. | Posted | at time of positive MRSA results |
|
2 years following enrollment into the study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 21 | 1 | 21 | 0 | 21 |
| EG001 | 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. | 0 | 28 | 0 | 28 | 0 | 28 |
| EG002 | No MRSA Colonization | Patients who did not have any MRSA colonization. | 0 | 501 | 0 | 501 | 0 | 501 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization for gastroparesis | Gastrointestinal disorders | Non-systematic Assessment |
|
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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.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Brian Agan, Deputy Science Director | Infectious Disease Clinical Research Program, USUHS and HJF | 301-816-8446 | bagan@idcrp.org |
| Nov 21, 2017 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D013203 | Staphylococcal Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D016712 | Mupirocin |
| D006582 | Hexachlorophene |
| D014260 | Triclosan |
| ID | Term |
|---|---|
| D004852 | Epoxy Compounds |
| D004988 | Ethers, Cyclic |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D002733 | Chlorophenols |
| D002722 | Chlorobenzenes |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D010647 | Phenyl Ethers |
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| Male |
|
| African-American |
|
| Other |
|
| 350-499 cells/mm3 |
|
| >/= 500 cells/mm3 |
|
| No MRSA Colonization |
Patients who did not have any MRSA colonization. |
|
|
Patients who did not have any MRSA colonization. |
|
Patients who did not have any MRSA colonization. |
|