Trial Outcomes & Findings for Prospective Study of Methicillin-Resistant Staphylococcus Aureus (MRSA) Among HIV-Infected Persons (NCT NCT00631566)
NCT ID: NCT00631566
Last Updated: 2023-03-03
Results Overview
MRSA colonization at 6-months post-randomization
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
550 participants
Primary outcome timeframe
6 months
Results posted on
2023-03-03
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
No MRSA Colonization
Patients who did not have any MRSA colonization.
|
|---|---|---|---|
|
Overall Study
STARTED
|
21
|
28
|
501
|
|
Overall Study
COMPLETED
|
19
|
24
|
501
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prospective Study of Methicillin-Resistant Staphylococcus Aureus (MRSA) Among HIV-Infected Persons
Baseline characteristics by cohort
| Measure |
Mupirocin/Hexachlorophene Group
n=21 Participants
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.
|
Placebo Group
n=28 Participants
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.
|
No MRSA Colonization
n=501 Participants
Patients who did not have any MRSA colonization.
|
Total
n=550 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
41 years
n=5 Participants
|
46 years
n=7 Participants
|
42 years
n=5 Participants
|
42 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
465 Participants
n=5 Participants
|
513 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
9 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
287 Participants
n=5 Participants
|
311 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
African-American
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
174 Participants
n=5 Participants
|
196 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
28 participants
n=7 Participants
|
501 participants
n=5 Participants
|
550 participants
n=4 Participants
|
|
Current CD4 count
|
494 cells/mm3
n=5 Participants
|
500 cells/mm3
n=7 Participants
|
534 cells/mm3
n=5 Participants
|
529 cells/mm3
n=4 Participants
|
|
CD4 by category
<350 cells/mm3
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
102 Participants
n=4 Participants
|
|
CD4 by category
350-499 cells/mm3
|
4 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
133 Participants
n=4 Participants
|
|
CD4 by category
>/= 500 cells/mm3
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
290 Participants
n=5 Participants
|
314 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Only 80% of the 49 initial randomizations had 6-month colonization data and were analyzed.
MRSA colonization at 6-months post-randomization
Outcome measures
| Measure |
Mupirocin/Hexachlorophene Group
n=18 Participants
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.
|
Placebo Group
n=21 Participants
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.
|
No MRSA Colonization
n=501 Participants
Patients who did not have any MRSA colonization.
|
|---|---|---|---|
|
The Presence of MRSA on Repeated Swabs to Assess the Efficacy of These Medications on Clearing MRSA Colonization
|
12 Participants
|
14 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Every 6 monthsPopulation: 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.
Outcome measures
| Measure |
Mupirocin/Hexachlorophene Group
n=21 Participants
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.
|
Placebo Group
n=28 Participants
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.
|
No MRSA Colonization
n=501 Participants
Patients who did not have any 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
|
17 Participants
|
18 Participants
|
0 Participants
|
|
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
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.
|
NA Participants
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.
|
0 Participants
|
|
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
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.
|
NA Participants
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.
|
0 Participants
|
|
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
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.
|
NA Participants
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.
|
0 Participants
|
|
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
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.
|
NA Participants
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.
|
0 Participants
|
SECONDARY outcome
Timeframe: At time of infectionPopulation: As requested, the number of participants was set to zero since this analysis was not conducted.
This outcome measure was not analyzed/reported due to resource limitations.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: at time of positive MRSA resultsPopulation: As requested, the number of participants was set to zero since this analysis was not conducted.
This outcome measure was not analyzed/reported due to resource limitation.
Outcome measures
Outcome data not reported
Adverse Events
Mupirocin/Hexachlorophene Group
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No MRSA Colonization
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mupirocin/Hexachlorophene Group
n=21 participants at risk
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.
|
Placebo Group
n=28 participants at risk
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.
|
No MRSA Colonization
n=501 participants at risk
Patients who did not have any MRSA colonization.
|
|---|---|---|---|
|
Gastrointestinal disorders
Hospitalization for gastroparesis
|
4.8%
1/21 • Number of events 1 • 2 years following enrollment into the study
|
0.00%
0/28 • 2 years following enrollment into the study
|
0.00%
0/501 • 2 years following enrollment into the study
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Brian Agan, Deputy Science Director
Infectious Disease Clinical Research Program, USUHS and HJF
Phone: 301-816-8446
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place