Ignite Creation Date:
2025-12-24 @ 4:03 PM
Ignite Modification Date:
2025-12-28 @ 4:39 PM
Study NCT ID:
NCT00631566
Status:
COMPLETED
Last Update Posted:
2023-03-03
First Post:
2008-02-27
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Prospective Study of Methicillin-Resistant Staphylococcus Aureus (MRSA) Among HIV-Infected Persons
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D013203', 'term': 'Staphylococcal Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016712', 'term': 'Mupirocin'}, {'id': 'D006582', 'term': 'Hexachlorophene'}, {'id': 'D014260', 'term': 'Triclosan'}], 'ancestors': [{'id': 'D004852', 'term': 'Epoxy Compounds'}, {'id': 'D004988', 'term': 'Ethers, Cyclic'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D002733', 'term': 'Chlorophenols'}, {'id': 'D002722', 'term': 'Chlorobenzenes'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D010647', 'term': 'Phenyl Ethers'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bagan@idcrp.org', 'phone': '301-816-8446', 'title': 'Dr. Brian Agan, Deputy Science Director', 'organization': 'Infectious Disease Clinical Research Program, USUHS and HJF'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': '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.'}}, 'adverseEventsModule': {'timeFrame': '2 years following enrollment into the study', 'eventGroups': [{'id': 'EG000', 'title': 'Mupirocin/Hexachlorophene Group', 'description': 'Participants with MRSA colonization who were randomized to receive:\n\nMupirocin (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).\n\npHisoHex, brand of hexachlorophene detergent cleanser, is an antibacterial sudsing emulsion for topical administration.\n\nSome randomized patients will receive mupirocin (Bactroban) nasal ointment plus hexachlorophene (pHisoHex) body washes for seven days.', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo Group', 'description': 'Participants with MRSA colonization who were randomized to receive:\n\nPlacebo: Some randomized patients will receive a placebo nasal ointment (white petroleum) and a placebo body soap with no antimicrobial activity for seven days.', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 0, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'No MRSA Colonization', 'description': 'Patients who did not have any MRSA colonization.', 'otherNumAtRisk': 501, 'deathsNumAtRisk': 501, 'otherNumAffected': 0, 'seriousNumAtRisk': 501, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Hospitalization for gastroparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 501, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Presence of MRSA on Repeated Swabs to Assess the Efficacy of These Medications on Clearing MRSA Colonization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '501', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Mupirocin/Hexachlorophene Group', 'description': 'Participants with MRSA colonization who were randomized to receive:\n\nMupirocin (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).\n\npHisoHex, brand of hexachlorophene detergent cleanser, is an antibacterial sudsing emulsion for topical administration.\n\nSome randomized patients will receive mupirocin (Bactroban) nasal ointment plus hexachlorophene (pHisoHex) body washes for seven days.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Participants with MRSA colonization who were randomized to receive:\n\nPlacebo: Some randomized patients will receive a placebo nasal ointment (white petroleum) and a placebo body soap with no antimicrobial activity for seven days.'}, {'id': 'OG002', 'title': 'No MRSA Colonization', 'description': 'Patients who did not have any MRSA colonization.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'MRSA colonization at 6-months post-randomization', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 80% of the 49 initial randomizations had 6-month colonization data and were analyzed.'}, {'type': 'SECONDARY', 'title': '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.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '501', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Mupirocin/Hexachlorophene Group', 'description': 'Participants with MRSA colonization who were randomized to receive:\n\nMupirocin (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).\n\npHisoHex, brand of hexachlorophene detergent cleanser, is an antibacterial sudsing emulsion for topical administration.\n\nSome randomized patients will receive mupirocin (Bactroban) nasal ointment plus hexachlorophene (pHisoHex) body washes for seven days.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Participants with MRSA colonization who were randomized to receive:\n\nPlacebo: Some randomized patients will receive a placebo nasal ointment (white petroleum) and a placebo body soap with no antimicrobial activity for seven days.'}, {'id': 'OG002', 'title': 'No MRSA Colonization', 'description': 'Patients who did not have any MRSA colonization.'}], 'classes': [{'title': 'Nares', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Throat', 'categories': [{'measurements': [{'value': 'NA', 'comment': '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.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': '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.', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Perirectal', 'categories': [{'measurements': [{'value': 'NA', 'comment': '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.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': '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.', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Groin', 'categories': [{'measurements': [{'value': 'NA', 'comment': '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.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': '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.', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Axilla', 'categories': [{'measurements': [{'value': 'NA', 'comment': '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.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': '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.', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Every 6 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'To Evaluate the Change in CD4 Counts and HIV Viral Loads During the Time of a MRSA or Soft Tissue Infection.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Mupirocin/Hexachlorophene Group', 'description': 'Participants with MRSA colonization who were randomized to receive:\n\nMupirocin (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).\n\npHisoHex, brand of hexachlorophene detergent cleanser, is an antibacterial sudsing emulsion for topical administration.\n\nSome randomized patients will receive mupirocin (Bactroban) nasal ointment plus hexachlorophene (pHisoHex) body washes for seven days.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Participants with MRSA colonization who were randomized to receive:\n\nPlacebo: Some randomized patients will receive a placebo nasal ointment (white petroleum) and a placebo body soap with no antimicrobial activity for seven days.'}, {'id': 'OG002', 'title': 'No MRSA Colonization', 'description': 'Patients who did not have any MRSA colonization.'}], 'timeFrame': 'At time of infection', 'description': 'This outcome measure was not analyzed/reported due to resource limitations.', 'reportingStatus': 'POSTED', 'populationDescription': 'As requested, the number of participants was set to zero since this analysis was not conducted.'}, {'type': 'SECONDARY', 'title': 'To Characterize the Molecular Characteristics and the Antimicrobial Sensitivities of MRSA Isolates in This Population.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Mupirocin/Hexachlorophene Group', 'description': 'Participants with MRSA colonization who were randomized to receive:\n\nMupirocin (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).\n\npHisoHex, brand of hexachlorophene detergent cleanser, is an antibacterial sudsing emulsion for topical administration.\n\nSome randomized patients will receive mupirocin (Bactroban) nasal ointment plus hexachlorophene (pHisoHex) body washes for seven days.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Participants with MRSA colonization who were randomized to receive:\n\nPlacebo: Some randomized patients will receive a placebo nasal ointment (white petroleum) and a placebo body soap with no antimicrobial activity for seven days.'}, {'id': 'OG002', 'title': 'No MRSA Colonization', 'description': 'Patients who did not have any MRSA colonization.'}], 'timeFrame': 'at time of positive MRSA results', 'description': 'This outcome measure was not analyzed/reported due to resource limitation.', 'reportingStatus': 'POSTED', 'populationDescription': 'As requested, the number of participants was set to zero since this analysis was not conducted.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Mupirocin/Hexachlorophene Group', 'description': 'Participants with MRSA colonization who were randomized to receive:\n\nMupirocin (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).\n\npHisoHex, brand of hexachlorophene detergent cleanser, is an antibacterial sudsing emulsion for topical administration.\n\nSome randomized patients will receive mupirocin (Bactroban) nasal ointment plus hexachlorophene (pHisoHex) body washes for seven days.'}, {'id': 'FG001', 'title': 'Placebo Group', 'description': 'Participants with MRSA colonization who were randomized to receive:\n\nPlacebo: Some randomized patients will receive a placebo nasal ointment (white petroleum) and a placebo body soap with no antimicrobial activity for seven days.'}, {'id': 'FG002', 'title': 'No MRSA Colonization', 'description': 'Patients who did not have any MRSA colonization.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '501'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '501'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '501', 'groupId': 'BG002'}, {'value': '550', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Mupirocin/Hexachlorophene Group', 'description': 'Participants with MRSA colonization who were randomized to receive:\n\nMupirocin (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).\n\npHisoHex, brand of hexachlorophene detergent cleanser, is an antibacterial sudsing emulsion for topical administration.\n\nSome randomized patients will receive mupirocin (Bactroban) nasal ointment plus hexachlorophene (pHisoHex) body washes for seven days.'}, {'id': 'BG001', 'title': 'Placebo Group', 'description': 'Participants with MRSA colonization who were randomized to receive:\n\nPlacebo: Some randomized patients will receive a placebo nasal ointment (white petroleum) and a placebo body soap with no antimicrobial activity for seven days.'}, {'id': 'BG002', 'title': 'No MRSA Colonization', 'description': 'Patients who did not have any MRSA colonization.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000', 'lowerLimit': '34', 'upperLimit': '47'}, {'value': '46', 'groupId': 'BG001', 'lowerLimit': '38', 'upperLimit': '52'}, {'value': '42', 'groupId': 'BG002', 'lowerLimit': '32', 'upperLimit': '49'}, {'value': '42', 'groupId': 'BG003', 'lowerLimit': '33', 'upperLimit': '49'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '465', 'groupId': 'BG002'}, {'value': '513', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '287', 'groupId': 'BG002'}, {'value': '311', 'groupId': 'BG003'}]}]}, {'title': 'African-American', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '174', 'groupId': 'BG002'}, {'value': '196', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '501', 'groupId': 'BG002'}, {'value': '550', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Current CD4 count', 'classes': [{'categories': [{'measurements': [{'value': '494', 'groupId': 'BG000', 'lowerLimit': '312', 'upperLimit': '695'}, {'value': '500', 'groupId': 'BG001', 'lowerLimit': '424', 'upperLimit': '618'}, {'value': '534', 'groupId': 'BG002', 'lowerLimit': '404', 'upperLimit': '706'}, {'value': '529', 'groupId': 'BG003', 'lowerLimit': '402', 'upperLimit': '704'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'cells/mm3', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'CD4 by category', 'classes': [{'title': '<350 cells/mm3', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}, {'value': '102', 'groupId': 'BG003'}]}]}, {'title': '350-499 cells/mm3', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}, {'value': '133', 'groupId': 'BG003'}]}]}, {'title': '>/= 500 cells/mm3', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '290', 'groupId': 'BG002'}, {'value': '314', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-07-02', 'size': 457516, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2017-11-21T16:52', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 550}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-01', 'studyFirstSubmitDate': '2008-02-27', 'resultsFirstSubmitDate': '2017-11-30', 'studyFirstSubmitQcDate': '2008-03-06', 'lastUpdatePostDateStruct': {'date': '2023-03-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-07-18', 'studyFirstPostDateStruct': {'date': '2008-03-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Presence of MRSA on Repeated Swabs to Assess the Efficacy of These Medications on Clearing MRSA Colonization', 'timeFrame': '6 months', 'description': 'MRSA colonization at 6-months post-randomization'}], 'secondaryOutcomes': [{'measure': '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.', 'timeFrame': 'Every 6 months'}, {'measure': 'To Evaluate the Change in CD4 Counts and HIV Viral Loads During the Time of a MRSA or Soft Tissue Infection.', 'timeFrame': 'At time of infection', 'description': 'This outcome measure was not analyzed/reported due to resource limitations.'}, {'measure': 'To Characterize the Molecular Characteristics and the Antimicrobial Sensitivities of MRSA Isolates in This Population.', 'timeFrame': 'at time of positive MRSA results', 'description': 'This outcome measure was not analyzed/reported due to resource limitation.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIV', 'Methicillin-resistant Staphylococcus aureus (MRSA)', 'HIV and Staphylococcus aureus infection'], 'conditions': ['HIV Infections', 'Staphylococcal Infections']}, 'referencesModule': {'references': [{'pmid': '23603632', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '22033452', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '26018036', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '26380335', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n\nExclusion Criteria:\n\n* Known allergy to mupirocin (Bactroban®) nasal ointment or hexachlorophene (pHisoHex®) soaps or constituents of these products.\n* Age less than 18 years.\n* Inability to remain in the study for the two year duration.\n* Pregnant or breastfeeding females.\n* Females who intend to become pregnant during the two year study time period.\n* Persons who are healthcare providers with direct patient contact.'}, 'identificationModule': {'nctId': 'NCT00631566', 'acronym': 'MRSA', 'briefTitle': 'Prospective Study of Methicillin-Resistant Staphylococcus Aureus (MRSA) Among HIV-Infected Persons', 'organization': {'class': 'OTHER', 'fullName': 'Henry M. Jackson Foundation for the Advancement of Military Medicine'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'IDCRP-003-RV210'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: Mupirocin (Bactroban) 2%; hexachlorophene (pHisoHex) 3%']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Placebo']}, {'type': 'NO_INTERVENTION', 'label': 'No MRSA colonization'}], 'interventions': [{'name': 'Mupirocin (Bactroban) 2%; hexachlorophene (pHisoHex) 3%', 'type': 'DRUG', 'description': '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).\n\npHisoHex, brand of hexachlorophene detergent cleanser, is an antibacterial sudsing emulsion for topical administration.\n\nSome randomized patients will receive mupirocin (Bactroban) nasal ointment plus hexachlorophene (pHisoHex) body washes for seven days.', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Some randomized patients will receive a placebo nasal ointment (white petroleum) and a placebo body soap with no antimicrobial activity for seven days.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92134-1201', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Naval Medical Center San Diego/Infectious Disease Division', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '20889', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'Walter Reed National Military Medical Center', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '78236-9908', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'San Antonio Military Medical Center (BAMC/WHMC)', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '23708-2197', 'city': 'Portsmouth', 'state': 'Virginia', 'country': 'United States', 'facility': 'Naval Medical Center Portsmouth', 'geoPoint': {'lat': 36.83543, 'lon': -76.29827}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henry M. Jackson Foundation for the Advancement of Military Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Infectious Diseases Clinical Research Program', 'class': 'OTHER'}, {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, {'name': 'US Military HIV Research Program', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'SPONSOR'}}}}