Infant Antibiotic Resistance and Implications for Therapeutic Decision-making

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2013 by University Hospital Case Medical Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sharon Meropol, MD, PhD, University Hospital Case Medical Center
ClinicalTrials.gov Identifier:
NCT01781182
First received: January 29, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  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 Hospital Case 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 Without DNA

specific cultured antibiotic resistant organisms of interest


Estimated Enrollment: 300
Study Start Date: February 2013
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   up to 18 Months
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

Contacts
Contact: Sharon B Meropol, MD, PhD 216-844-8260 sharon.meropol@gmail.com

Locations
United States, Ohio
University Hospitals Case Medical Center Not yet recruiting
Cleveland, Ohio, United States, 44106
Contact: Sharon B Meropol, MD, PhD    216-844-8260    sharon.meropol@uhhospitals.org   
Sponsors and Collaborators
University Hospital Case Medical Center
  More Information

No publications provided

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

Additional relevant MeSH terms:
Bacterial Infections

ClinicalTrials.gov processed this record on September 30, 2014