Recruiting

Observational Study

Sponsor:

Boston Children's Hospital

Code:

NCT02271243

Conditions

Laboratory-confirmed Bloodstream Infection

Central Line-associated Bloodstream Infections

Mucosal Barrier Injury

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT02271243

Start date

Nov, 2014

Status verified date

May, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

Subject with suspected MBI

Subjects without suspected MBI

Primary outcome measure

  • Phylogenetic relationships (on SNP scale) of bacteria isolated from different body sites [ Time Frame: Up to 2 years ]

Central Contacts and Locations

Central contacts

Rachel Bernier, MPH

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

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Gregory Priebe, MD

617-355-7327Gregory.Priebe@childrens.harvard.edu

Thomas Sandora, MD,MPH

617-355-3858Thomas.Sandora@childrens.harvard.edu

Principal Investigator:

Gregory Priebe, MD

More Information

Sponsor

Boston Children's Hospital

Last update posted

May 15, 2026

Last verified

May, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2026-05-15.