Using Microbial Genomics to Elucidate the Source of Central-line Associated Bloodstream Infections

Sponsor

Boston Children's Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT02271243

Collaborator

(none)

Enrollment

Location

109

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Central line-associated bloodstream infections (CLABSIs) are the most common healthcare-associated infection in children and are associated with morbidity and mortality. This study will attempt to identify the source of bloodstream infections (BSIs) in children with CLABSI because we hypothesize that many of the BSIs that are currently classified as CLABSIs are actually laboratory-confirmed bloodstream infections (LCBI) that may be a result of mucosal barrier injury (MBI), also known as MBI-LCBI. In order to study this, we will isolate bacteria from multiple body sites of children that have BSI in order to compare these bacteria to the strain growing in their blood using whole-genome DNA sequencing. We will also evaluate biomarkers of MBI of the respiratory tract and GI tract.

Condition or Disease	Intervention/Treatment	Phase
Laboratory-confirmed Bloodstream Infection Central Line-associated Bloodstream Infections Mucosal Barrier Injury

Detailed Description

This is a prospective cohort pilot study at Boston Children's Hospital (BCH) that will explore the source of presumed CLABSI, which we believe may actually have multiple possible sources including MBI. We plan to enroll all inpatient children at BCH who meet the Centers for Disease Control and Prevention (CDC) definition of MBI-LCBI as well as children who meet the criteria for CLABSI without MBI. For all enrolled patients, we will collect samples from the oral cavity, respiratory tract, skin, and stool. These samples will be cultured in order to see if the same microbial species and strain(s) growing from the blood also grow from these other sites. Cultures will then have isolated colonies selected for whole-genome DNA sequencing to allow assessment of genomic diversity between body sites. Stool and blood samples will be tested for markers of MBI. All patient enrollment and sample collection will be done at BCH.

Study Design

Study Type:

Observational

Anticipated Enrollment :

60 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Using Microbial Genomics to Elucidate the Source of Central-line Associated Bloodstream Infections

Actual Study Start Date :

Nov 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Subject with suspected MBI
Subjects without suspected MBI

Outcome Measures

Primary Outcome Measures

Phylogenetic relationships (on SNP scale) of bacteria isolated from different body sites [Up to 2 years]
Phylogeny will be determined using whole-genome DNA sequences of multiple bacterial colonies that grow from each body site.

Secondary Outcome Measures

Levels of biomarkers of MBI in the blood and stool (citrulline in blood, calprotectin in stool) [Up to 2 years]
Low citrulline and high calprotectin indicate GI tract mucosal barrier injury.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Hospitalized at Boston Children's Hospital
Central venous catheter of any type including peripherally inserted central catheters (PICC) in any location.
Laboratory-confirmed bloodstream infection (LCBI) diagnosed by a clinical blood culture growing certain Gram-negative rods