Ignite Creation Date:
2024-05-06 @ 9:51 AM
Last Modification Date:
2024-10-26 @ 12:21 PM
Study NCT ID:
NCT03098485
Status:
COMPLETED
Last Update Posted:
2022-11-10
First Post:
2017-01-11
Brief Title:
Healthy Patients Effect of Antibiotics
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
Prospective Study Characterizing Fecal Microbiome Disruptions During and After Receipt of Antimicrobials
Status:
COMPLETED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 ie 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 persons microbiome may reduce hisher colonization resistance resistance to colonization with pathogenic microorganisms and make himher 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
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
Detailed Description:
Each year antimicrobial resistance causes over two million infections and 23000 deaths in the US alone representing a critical global public health issue Some of the most feared multidrug resistant organisms MDROs include Clostridium difficile carbapenem-resistant Enterobacteriaceae CRE extended spectrum beta-lactamase producing Enterobacteriaceae ESBL MDRO Acinetobacter and MDRO Pseudomonas aeruginosa there are few antimicrobials effective against these MDROs and available antimicrobials often have rate-limiting toxicities The major risk factor for MDRO colonization and subsequent MDRO infections is exposure to antimicrobials The use of antimicrobials has been associated with an altered and often less diverse composition of the fecal microbiome and expansion of the resistome A healthy microbiome provides colonization resistance against potentially pathogenic bacteria antimicrobials disrupt this protective community providing selective pressure that favors MDRO colonization persistence and transmission to others
Methods to proactively prevent MDRO colonization rather than reliance on reactive approaches to this problem are urgently needed Antimicrobial stewardship is a key component of MDRO prevention efforts however there is no method to determine which antimicrobials cause the greatest degree of microbiome disruption A better understanding of exactly how antimicrobials alter the microbiome is necessary to optimally guide future MDRO prevention efforts and antimicrobial stewardship The development of microbiome disruption indices MDIs would help characterize the risk associated with specific antimicrobials and can be used during antimicrobial development patient monitoring while on antimicrobials and to facilitate infection prevention efforts to contain MDRO spread Additionally MDIs can be used as an alert when microbiome disruptions reach a critical level and MDRO colonization is imminent At that point interventions to restore the microbiome could be implemented
Community-acquired pneumonia CAP is one of the leading causes of death in the United States with an estimated 900000 cases each year in adults age 65 and older Large amounts of antimicrobials are used in treating patients with CAP because the disease is relatively common A better understanding of the effect of CAP antimicrobial treatment on the microbiome could result in improved treatment options for patients with CAP and protect CAP patients from colonization or infection with MDROs
Methods to proactively prevent MDRO colonization rather than reliance on reactive approaches to this problem are urgently needed Antimicrobial stewardship is a key component of MDRO prevention efforts however there is no method to determine which antimicrobials cause the greatest degree of microbiome disruption A better understanding of exactly how antimicrobials alter the microbiome is necessary to optimally guide future MDRO prevention efforts and antimicrobial stewardship The development of microbiome disruption indices MDIs would help characterize the risk associated with specific antimicrobials and can be used during antimicrobial development patient monitoring while on antimicrobials and to facilitate infection prevention efforts to contain MDRO spread Additionally MDIs can be used as an alert when microbiome disruptions reach a critical level and MDRO colonization is imminent At that point interventions to restore the microbiome could be implemented
Community-acquired pneumonia CAP is one of the leading causes of death in the United States with an estimated 900000 cases each year in adults age 65 and older Large amounts of antimicrobials are used in treating patients with CAP because the disease is relatively common A better understanding of the effect of CAP antimicrobial treatment on the microbiome could result in improved treatment options for patients with CAP and protect CAP patients from colonization or infection with MDROs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None