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Infant Antibiotic Resistance and Implications for Therapeutic Decision-making

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Sharon Meropol, MD, PhD, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier:
NCT01781182
First received: January 29, 2013
Last updated: October 24, 2016
Last verified: October 2016
  Purpose

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
Bacterial Infections and Mycoses

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Infant Antibiotic Resistance and Implications for Therapeutic Decision-making

Resource links provided by NLM:


Further study details as provided by University Hospitals Cleveland Medical Center:

Primary Outcome Measures:
  • Colonization with resistant organism of interest [ Time Frame: First 12 months of life ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
specific cultured antibiotic resistant organisms of interest Stool specimens Stool DNA

Enrollment: 352
Study Start Date: February 2013
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   up to 18 Months   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Newborn infants from the well baby nursery, followed during their first year of life
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01781182

Locations
United States, Ohio
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)
  More Information

Responsible Party: Sharon Meropol, MD, PhD, Assistant Professor of Pediatrics and Epidemiology and Biostatistics9, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT01781182     History of Changes
Other Study ID Numbers: 1K23AI097284-01A1 
Study First Received: January 29, 2013
Last Updated: October 24, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Mycoses
Bacterial Infections
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on December 08, 2016