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

Central Line-associated Bloodstream Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02271243
• Other study ID #: P00012105
• Status: Recruiting
• Start date: November 2014
• Est. completion date: December 2025

Study information

• Verified date: January 2024
• Source: Boston Children's Hospital
• Contact: Rachel Bernier, MPH
• Phone: 857-218-5348
• Email: Rachel.Bernier[@]childrens.harvard.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Exclusion Criteria:

• Patients with CDC-defined secondary bloodstream infections

Related Conditions & MeSH terms

• Central Line-associated Bloodstream Infections
• Communicable Diseases
• Infections
• Laboratory-confirmed Bloodstream Infection
• Mucosal Barrier Injury
• Sepsis

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phylogenetic relationships (on SNP scale) of bacteria isolated from different body sites	Phylogeny will be determined using whole-genome DNA sequences of multiple bacterial colonies that grow from each body site.	Up to 2 years
Secondary	Levels of biomarkers of MBI in the blood and stool (citrulline in blood, calprotectin in stool)	Low citrulline and high calprotectin indicate GI tract mucosal barrier injury.	Up to 2 years