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Infant Antibiotic Resistance and Implications for Therapeutic Decision-making

Sponsor
University Hospitals Cleveland Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT01781182
Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
352
Enrollment
1
Location
48.9
Actual Duration (Months)
7.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Escalating resistance to antibiotics among disease-causing community bacteria increasingly threatens our ability to treat patients' infections. At the level of the physician-patient encounter, incentives at the patient level often take priority to society; this is often the case with antibiotic prescribing. Each patient level antibiotic treatment decision is based on how we value potential outcomes, including short-term benefits and risks and longer-term risks, including those related to future bacterial resistance to antibiotics. Unfortunately, antibiotics are often prescribed for illnesses unlikely to have a bacterial etiology; even a very small likelihood of benefit seems to outweigh an increased risk of future antibiotic resistance. While short-term effects of antibiotics on colonization with resistant bacteria have been demonstrated, the overall implications of each treatment for future individual, family and societal-level resistance remain difficult to quantify, and are often steeply discounted or ignored during decision-making. Knowledge regarding the longer-term effects of personal and household antibiotic use could better quantify these future resistance-related risks, and help guide antibiotic decision-making for physicians and patients.

Infants are born with sterile nasopharyngeal and gastrointestinal tracts and yet, during the 1st year of life, become important reservoirs of resistant organisms; this creates an opportunity to study colonization and resistance starting from a microbiological tabula rasa. In this proposal, we will use an observational cohort to following newborns' antibiotic exposure and longitudinal colonization with specific bacterial pathogens and related antibiotic resistance in the 1st year of life. Our hypothesis is that during the 1st year of life, infants with personal and household antibiotic exposure will have greater colonization with resistan organisms than infants without antibiotic exposure. This project will help us understand the development of bacteria that are resistant to antibiotics within the community, and help to inform judicious decision-making regarding antibiotic prescribing.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    352 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Infant Antibiotic Resistance and Implications for Therapeutic Decision-making
    Actual Study Start Date :
    Feb 1, 2013
    Actual Primary Completion Date :
    Mar 1, 2017
    Actual Study Completion Date :
    Mar 1, 2017

    Outcome Measures

    Primary Outcome Measures

    1. Colonization with resistant organism of interest [First 12 months of life]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 18 Months
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Infant in regular nursery at University Hospitals CWRU

    • Mother has legal custody

    • Mother is >=18 years old

    • Mother's and baby's physicians have granted permission for possible enrollment

    • Mother speaks, reads and understands the English language

    Exclusion Criteria:
    • Does not fit inclusion criteria

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospitals Case Medical Center Cleveland Ohio United States 44106

    Sponsors and Collaborators

    • University Hospitals Cleveland Medical Center
    • National Institute of Allergy and Infectious Diseases (NIAID)

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sharon Meropol, MD, PhD, Assistant Professor of Pediatrics and Epidemiology and Biostatistics9, University Hospitals Cleveland Medical Center
    ClinicalTrials.gov Identifier:
    NCT01781182
    Other Study ID Numbers:
    • 1K23AI097284-01A1
    • 1K23AI097284-01A1
    First Posted:
    Jan 31, 2013
    Last Update Posted:
    May 3, 2017
    Last Verified:
    May 1, 2017
    Additional relevant MeSH terms:
    Mycoses
    Bacterial Infections
    Bacterial Infections and Mycoses

    Study Results

    No Results Posted as of May 3, 2017