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NCT04222699 · ClinicalTrials.gov registry record · Phase 4
Cultures Before and After Decolonization in Community Dwelling Adults With Current S. Aureus Colonization
A Phase 4 study of Human Microbiome, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 4
- Development phase
- 58
- Enrollment target
- 1
- Study location
NCT04222699: Completed Phase 4 study of Human Microbiome, sponsored by VA Office of Research and Development.
NCT04222699 is a Phase 4 study of Human Microbiome that has completed, run by VA Office of Research and Development. The registered enrollment target is 58 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04222699, a Phase 4 study of Human Microbiome, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 58 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Change in the abundance of Staphylococcus aureus in the nose from immediately before mupirocin administration to 8 weeks after mupirocin administration.
Conditions Studied
Interventions
- DRUG Mupirocin calcium ointment, 2%
- DRUG Topical Chlorhexidine, 4%
Study Locations (1)
Maryland
- Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2012-09-18 |
| Est. Completion | 2014-11-18 |
| Phase | Phase 4 |
What the finished NCT04222699 record still lists
NCT04222699 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Human Microbiome appearing as the primary indexed condition, and to 2 interventions - of which Mupirocin calcium ointment, 2% is the first listed.
NCT04222699 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04222699 about?
NCT04222699 is a clinical study titled "Cultures Before and After Decolonization in Community Dwelling Adults With Current S. Aureus Colonization". 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...
What is the current status of trial NCT04222699?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 58 participants. The study started on 2012-09-18. Estimated completion is 2014-11-18.
What conditions does trial NCT04222699 study?
This clinical trial studies the following conditions: Human Microbiome.
What interventions are being tested in trial NCT04222699?
The interventions under investigation include: Mupirocin calcium ointment, 2% (DRUG), Topical Chlorhexidine, 4% (DRUG).
Who is sponsoring clinical trial NCT04222699?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04222699 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04222699's enrollment target sits among peer trials
58 1205th of 2000 higher than 793 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
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Source ClinicalTrials.gov registry export · 2026-08-08
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