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Infant Antibiotic Resistance and Implications for Therapeutic Decision-making

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ClinicalTrials.gov Identifier: NCT01781182
Recruitment Status : Completed
First Posted : January 31, 2013
Last Update Posted : May 3, 2017
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Sharon Meropol, MD, PhD, University Hospitals Cleveland Medical Center

January 29, 2013
January 31, 2013
May 3, 2017
February 2013
March 2017   (Final data collection date for primary outcome measure)
Colonization with resistant organism of interest [ Time Frame: First 12 months of life ]
Same as current
Complete list of historical versions of study NCT01781182 on ClinicalTrials.gov Archive Site
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Infant Antibiotic Resistance and Implications for Therapeutic Decision-making
Infant Antibiotic Resistance and Implications for Therapeutic Decision-making

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:
specific cultured antibiotic resistant organisms of interest Stool specimens Stool DNA
Non-Probability Sample
Newborn infants from the well baby nursery, followed during their first year of life
Bacterial Infections and Mycoses
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
352
300
March 2017
March 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
up to 18 Months   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01781182
1K23AI097284-01A1( U.S. NIH Grant/Contract )
1K23AI097284-01A1 ( U.S. NIH Grant/Contract )
No
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Sharon Meropol, MD, PhD, University Hospitals Cleveland Medical Center
University Hospitals Cleveland Medical Center
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
University Hospitals Cleveland Medical Center
May 2017