Cultures Before and After Decolonization in Community Dwelling Adults With Current S. Aureus Colo… (NCT04222699) | Clinical Trial Compass
CompletedPhase 4
Cultures Before and After Decolonization in Community Dwelling Adults With Current S. Aureus Colonization
United States58 participantsStarted 2012-09-18
Plain-language summary
The investigators propose to study the microbiome of the nose, throat and three skin sites in a population without current exposure to the healthcare environment: 80 community dwelling adults. We will characterize the microbial communities in these body sites (nose, throat, perirectal and three skin sites) over time using culture-independent techniques. The investigators will then "decolonize" the subjects. Subjects will receive intranasal mupirocin and topical chlorhexidine. The investigators will then compare the microbial communities at baseline and after decolonization within individuals. Our overall hypothesis is that the microbial composition of these sites and the response to decolonization is influenced by the healthcare environment and that decolonization leads to re-colonization with an increasing proportion of Gram-negative bacilli.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Veteran living in the greater Baltimore, MD area
* Adults \>= 18 years of age
* Living independently
* Willing and able to provide anterior nares, skin, throat, and perirectal specimens over an 18 week time period.
* Willing and able to administer intranasal mupirocin and topical chlorhexidine over a five day period
* Capable of understanding and complying with the entire study protocol.
* Provided signed and dated informed consent
Exclusion Criteria:
* Use of anticancer chemotherapy or radiation therapy (cytotoxic) within the past 6 months
* History of HIV infection with most recent CD4 of \<200
* Immunosuppression medications within the past 3 months
* Use of systemic antibacterial or antifungal agents in the past 3 months
* Use of nasal steroids currently or in the past 3 months
* Use of nasal antimicrobial ointment in the past 3 months
* Any current indwelling percutaneous medical device or urinary catheter
* Acute care hospitalization in the past 3 months
* Planned surgery or hospitalization during the study period
* History of an allergic reaction to chlorhexidine or mupirocin
* Oral temperature of \>100 F at enrollment visit
* BMI \<18 or \>35 at enrollment visit
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in the Abundance of Staphylococcus Aureus in the Nose After Decolonization
Timeframe: 8 weeks
2
Change in the Abundance of Staphylococcus Aureus in the Throat After Decolonization
Timeframe: 8 weeks
3
Change in the Abundance of Gram Negative Bacteria on the Subclavian Skin After Decolonization
Timeframe: 12 months
4
Change in the Abundance of Gram Negative Bacteria on the Femoral Skin After Decolonization