Trial Outcomes & Findings for Cultures Before and After Decolonization in Community Dwelling Adults With Current S. Aureus Colonization (NCT NCT04222699)

Last Updated: 2020-04-14

Results Overview

Change in the abundance of Staphylococcus aureus in the nose from immediately before mupirocin administration to 8 weeks after mupirocin administration.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

58 participants

Primary outcome timeframe

8 weeks

Results posted on

2020-04-14

Participant Flow

30 participants were S. aureus negative in the nose at enrollment and were withdrawn from the study as the use of mupirocin was not clinically indicated.

Participant milestones

Participant milestones
Measure	Intranasal Mupirocin and Topical Chlorhexidine Antimicrobial antiseptic skin cleanser (4% chlorhexidine) for daily use on Day 1, 3 and 5 of Week 8 of the study. BACTROBAN NASAL ointment (mupirocin calcium ointment, 2%) for use intranasally twice-daily on Day 1, 2, 3, 4 and 5 of Week 8 of the study. Mupirocin calcium ointment, 2%: Mupirocin nasal ointment is used to treat or prevent infections in the nose due to certain strains of Staphylococcus aureus bacteria. This medicine works by killing bacteria or preventing their growth. Topical Chlorhexidine, 4%: Chlorhexidine is an antiseptic that fights bacteria. Topical chlorhexidine is used to clean the skin to prevent infection that may be caused by surgery, injection, or skin injury.
Overall Study STARTED	28
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Intranasal Mupirocin and Topical Chlorhexidine Antimicrobial antiseptic skin cleanser (4% chlorhexidine) for daily use on Day 1, 3 and 5 of Week 8 of the study. BACTROBAN NASAL ointment (mupirocin calcium ointment, 2%) for use intranasally twice-daily on Day 1, 2, 3, 4 and 5 of Week 8 of the study. Mupirocin calcium ointment, 2%: Mupirocin nasal ointment is used to treat or prevent infections in the nose due to certain strains of Staphylococcus aureus bacteria. This medicine works by killing bacteria or preventing their growth. Topical Chlorhexidine, 4%: Chlorhexidine is an antiseptic that fights bacteria. Topical chlorhexidine is used to clean the skin to prevent infection that may be caused by surgery, injection, or skin injury.
Overall Study Lost to Follow-up	2

Baseline Characteristics

Cultures Before and After Decolonization in Community Dwelling Adults With Current S. Aureus Colonization

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intranasal Mupirocin and Topical Chlorhexidine n=28 Participants Antimicrobial antiseptic skin cleanser (4% chlorhexidine) for daily use on Day 1, 3 and 5 of Week 8 of the study. BACTROBAN NASAL ointment (mupirocin calcium ointment, 2%) for use intranasally twice-daily on Day 1, 2, 3, 4 and 5 of Week 8 of the study. Mupirocin calcium ointment, 2%: Mupirocin nasal ointment is used to treat or prevent infections in the nose due to certain strains of Staphylococcus aureus bacteria. This medicine works by killing bacteria or preventing their growth. Topical Chlorhexidine, 4%: Chlorhexidine is an antiseptic that fights bacteria. Topical chlorhexidine is used to clean the skin to prevent infection that may be caused by surgery, injection, or skin injury.
Age, Continuous	50.5 years STANDARD_DEVIATION 17.4 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	17 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	28 Participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: Out of the 28 participants assigned to this group, 2 were lost to follow-up and 1 had an insufficient amount of sample collected and could not be included in the analysis.

Change in the abundance of Staphylococcus aureus in the nose from immediately before mupirocin administration to 8 weeks after mupirocin administration.

Outcome measures

Outcome measures
Measure	Intranasal Mupirocin and Topical Chlorhexidine n=25 Participants Antimicrobial antiseptic skin cleanser (4% chlorhexidine) for daily use on Day 1, 3 and 5 of Week 8 of the study. BACTROBAN NASAL ointment (mupirocin calcium ointment, 2%) for use intranasally twice-daily on Day 1, 2, 3, 4 and 5 of Week 8 of the study. Mupirocin calcium ointment, 2%: Mupirocin nasal ointment is used to treat or prevent infections in the nose due to certain strains of Staphylococcus aureus bacteria. This medicine works by killing bacteria or preventing their growth. Topical Chlorhexidine, 4%: Chlorhexidine is an antiseptic that fights bacteria. Topical chlorhexidine is used to clean the skin to prevent infection that may be caused by surgery, injection, or skin injury.
Change in the Abundance of Staphylococcus Aureus in the Nose After Decolonization	-781 fg/uL Standard Deviation 3681

PRIMARY outcome

Timeframe: 8 weeks

Population: Out of the 28 participants assigned to this group, 2 were lost to follow-up and 1 had an insufficient amount of sample collected and could not be included in the analysis.

Change in the abundance of Staphylococcus aureus in the throat from immediately before mupirocin administration to 8 weeks after mupirocin administration.

Outcome measures

Outcome measures
Measure	Intranasal Mupirocin and Topical Chlorhexidine n=25 Participants Antimicrobial antiseptic skin cleanser (4% chlorhexidine) for daily use on Day 1, 3 and 5 of Week 8 of the study. BACTROBAN NASAL ointment (mupirocin calcium ointment, 2%) for use intranasally twice-daily on Day 1, 2, 3, 4 and 5 of Week 8 of the study. Mupirocin calcium ointment, 2%: Mupirocin nasal ointment is used to treat or prevent infections in the nose due to certain strains of Staphylococcus aureus bacteria. This medicine works by killing bacteria or preventing their growth. Topical Chlorhexidine, 4%: Chlorhexidine is an antiseptic that fights bacteria. Topical chlorhexidine is used to clean the skin to prevent infection that may be caused by surgery, injection, or skin injury.
Change in the Abundance of Staphylococcus Aureus in the Throat After Decolonization	-321 fg/uL Standard Deviation 7053

PRIMARY outcome

Timeframe: 12 months

Population: Subclavian skin samples deteriorated prior to sample analysis and cannot be used.

Quantitative PCR using 16S rRNA is used to quantify the total bacterial load of Gram negative bacteria on the subclavian skin before and after decolonization.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 12 months

Population: Femoral skin samples deteriorated prior to sample analysis and cannot be used.

Quantitative PCR using 16S rRNA is used to quantify the total bacterial load of Gram negative bacteria on the femoral skin before and after decolonization.

Outcome measures

Outcome data not reported

Adverse Events

Intranasal Mupirocin and Topical Chlorhexidine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Mary-Claire Roghmann

VA Maryland Healthcare System

Phone: 410 706 0062

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place