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NCT03098485 · ClinicalTrials.gov registry record · NA
Healthy Patients & Effect of Antibiotics
A NA study of Microbiota and Anti-bacterial Agents, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT03098485 is a NA study of Microbiota and Anti-bacterial Agents that has completed, run by Washington University School of Medicine. The registered enrollment target is 20 participants, below the 138-participant average among 10 other Microbiota trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03098485, a NA study of Microbiota and Anti-bacterial Agents, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
The objective of this study is to evaluate the impact of antimicrobial (antibiotic) exposures on the microbiome in healthy adults, specifically during and after usual courses of the antimicrobials used to treat community acquired pneumonia (CAP). Pneumonia is a lung infection, and community-acquired pneumonia is pneumonia that develops outside of a healthcare facility (i.e., in the community). A microbiome is a the community of microorganisms living in a particular location, such as the gut or the mouth. Disruptions to a person's microbiome may reduce his/her "colonization resistance" (resistance to colonization with pathogenic microorganisms) and make him/her more susceptible to multidrug resistant organism (MDRO) colonization and infection. To study changes in the microbiome, the investigators will recruit 20 healthy adult volunteers and obtain fecal, salivary, skin, and urine specimens at multiple time points before, during, and after administration of antimicrobials. Participants will be randomized to one of 4 antimicrobial regimens, all of which are FDA-approved for treatment of community-acquired pneumonia. Stool specimens will be analyzed via stool culture and genetic sequencing, and all remaining specimens will be frozen and used to create a biospecimen repository for future analysis. The rationale for using healthy volunteers (instead of patients already prescribed antibiotics by their physicians) is because the human microbiome is very complex and can be affected by a variety of medical conditions and other medications. In addition, the presence or absence of patient-specific factors means people with infections may not be prescribed the specific courses of antibiotics the investigators are trying to study. Studying the effect of antibiotics on healthy volunteers will provide baseline data that are more applicable to the population at large.
Conditions Studied
Interventions
- DRUG Azithromycin
- DRUG Levofloxacin
- DRUG Cefpodoxime
Study Locations (1)
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2017-01 |
| Est. Completion | 2022-08-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03098485
The ClinicalTrials.gov registry entry for NCT03098485 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 138-participant average among 10 other Microbiota trials with a reported enrollment target (86% lower). The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Microbiota appearing as the primary indexed condition, and to 3 interventions - of which Azithromycin is the first listed.
NCT03098485 reports 1 study location spanning 1 distinct geographic area - top geographies include Missouri.
Frequently Asked Questions
What is clinical trial NCT03098485 about?
NCT03098485 is a clinical study titled "Healthy Patients & Effect of Antibiotics". The objective of this study is to evaluate the impact of antimicrobial (antibiotic) exposures on the microbiome in healthy adults, specifically during and after usual courses of the antimicrobials used to treat community acquired pneumonia (CAP). Pneumonia is a lung infection, and community-acquired...
What is the current status of trial NCT03098485?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2017-01. Estimated completion is 2022-08-30.
What conditions does trial NCT03098485 study?
This clinical trial studies the following conditions: Microbiota, Anti-bacterial Agents.
What interventions are being tested in trial NCT03098485?
The interventions under investigation include: Azithromycin (DRUG), Levofloxacin (DRUG), Cefpodoxime (DRUG).
Who is sponsoring clinical trial NCT03098485?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03098485 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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