Trial Outcomes & Findings for Human Microbiome and Healthcare Associated Infections - Nursing Home Dwelling Older Veterans (NCT NCT04218799)

Last Updated: 2023-06-06

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

19 participants

Primary outcome timeframe

8 weeks

Results posted on

2023-06-06

Participant Flow

11 participants were S. aureus negative in the nose at enrollment and were withdrawn from the study as the use of mupirocin was not clinically indicated. 1 participant was discharged from the nursing home prior to receiving mupirocin.

Participant milestones

Participant milestones
Measure	Intranasal Mupirocin and Topical Chlorhexidine 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.
Overall Study STARTED	7
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Human Microbiome and Healthcare Associated Infections - Nursing Home Dwelling Older Veterans

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intranasal Mupirocin and Topical Chlorhexidine n=7 Participants 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.
Age, Continuous	71.0 years STANDARD_DEVIATION 14.4 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 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	1 Participants n=5 Participants
Race (NIH/OMB) White	5 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	7 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

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=7 Participants 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.
Change in the Abundance of Staphylococcus Aureus in the Nose After Decolonization	-4174 fg/uL Standard Deviation 11003

PRIMARY outcome

Timeframe: 8 weeks

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=7 Participants 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.
Change in the Abundance of Staphylococcus Aureus in the Throat After Decolonization	-3395 fg/uL Standard Deviation 8954

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

University of Maryland School of Medicine

Phone: 410 706 0062

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place