Infant Antibiotic Resistance and Implications for Therapeutic Decision-making

Bacterial Infections and Mycoses Clinical Trial

Official title:

Infant Antibiotic Resistance and Implications for Therapeutic Decision-making

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01781182
• Other study ID #: 1K23AI097284-01A1
• Secondary ID: 1K23AI097284-01A
• Status: Completed
• Phase: N/A
• First received: January 29, 2013
• Last updated: May 2, 2017
• Start date: February 2013
• Est. completion date: March 2017

Study information

• Verified date: May 2017
• Source: University Hospitals Cleveland Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 352
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Months

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Infections
• Bacterial Infections and Mycoses
• Mycoses

Locations

Country	Name	City	State
United States	University Hospitals Case Medical Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Colonization with resistant organism of interest		First 12 months of life