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N/A N=20 Randomized Double-blind Other

Healthy Patients & Effect of Antibiotics

Microbiota · Anti-bacterial Agents

Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Nov 2022
Primary outcome: Primary: Degree of Microbial Disruption: Number of Patients With Recovery of Bacterial Species Richness at 185 Days Post-antibiotics — 3; 3; 2; 3 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Levofloxacin (Drug); Azithromycin (Drug); Cefpodoxime (Drug)
Age
Adult · 21+ yrs
Sex
All
Sponsor
Washington University School of Medicine
Primary completion
Aug 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Degree of Microbial Disruption: Number of Patients With Recovery of Bacterial Species Richness at 185 Days Post-antibiotics
3; 3; 2; 3
PRIMARY
Degree of Microbial Disruption: Number of Patients With Increase in Antibiotic Resistance Genes at 185 Days Post-antibiotics
4; 5; 5; 4
PRIMARY
Degree of Microbial Disruption: Number of Patients With Continued Microbial Disruption at 185 Days Post-antibiotics
4; 4; 5; 5

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.

Eligibility Criteria

Inclusion Criteria

  • Healthy adults ages 21-60 residing in the St. Louis, Missouri, USA metropolitan area

Exclusion Criteria

  • History of allergic reaction to study antimicrobial(s)
  • Contraindication(s) to study antimicrobial(s)
  • Inability to provide regular stool samples
  • Any non-topical antimicrobial exposure in previous 6 months
  • Tube feeds as primary source of nutrition in previous 6 months
  • Pregnant or risk of becoming pregnant during study period
  • Breastfeeding during study period
  • Gastroenteritis in last 3 months
  • Any non-elective hospitalization in the previous 12 months
  • Incontinent of stool
  • Known colonization with an MDRO
  • Anticipated change in diet or medications during study period
  • Elective surgery during study period
  • History of an intestinal disorder
  • Inability to provide written, informed consent
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03098485). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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