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

NCT02271243 | Unknown

• 1 other identifier: P00012105
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Laboratory-confirmed Bloodstream Infection; Central Line-associated Bloodstream Infections; Mucosal Barrier Injury

Keywords

Central line-associated bloodstream infections; mucosal barrier injury; laboratory-confirmed bloodstream infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Levels of biomarkers of MBI in the blood and stool (citrulline in blood, calprotectin in stool)

  Up to 2 years

Study Arms (2)

Subject with suspected MBI

Subjects without suspected MBI

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Children with CLABSI

You may qualify if:

• 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

You may not qualify if:

• Patients with CDC-defined secondary bloodstream infections

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Bacteria growing from swab of oral cavity, sputum, skin, stool, and blood; stool and plasma samples.

Study Officials

• Gregory Priebe, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Bernier, MPH

CONTACT

857-218-5348; Rachel.Bernier@childrens.harvard.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician Critical Care & Infectious Disease

Study Record Dates

• First Submitted: October 17, 2014
• First Posted: October 22, 2014
• Study Start: November 1, 2014
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: January 10, 2024

Record last verified: 2024-01

Locations

US (1)