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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorBoston Children's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients with CDC-defined secondary bloodstream infections

Trial population

Children with CLABSI

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

60 Participants
are grouped into 2 trial groups
Group A: Subject with suspected MBI
Group B: Subjects without suspected MBI

Trial outcomes

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.

Time frame
Up to 2 years

Secondary outcomes

1

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.

Time frame
Up to 2 years

Other outcomes

Sponsors and contacts

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