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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02271243
Recruitment Status : Recruiting
First Posted : October 22, 2014
Last Update Posted : March 9, 2022
Information provided by (Responsible Party):
Gregory Priebe, Boston Children's Hospital

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
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.

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Study Type : Observational
Estimated 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 : November 2014
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Subject with suspected MBI
Subjects without suspected MBI

Primary Outcome Measures :
  1. Phylogenetic relationships (on SNP scale) of bacteria isolated from different body sites [ Time Frame: 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 :
  1. Levels of biomarkers of MBI in the blood and stool (citrulline in blood, calprotectin in stool) [ Time Frame: Up to 2 years ]
    Low citrulline and high calprotectin indicate GI tract mucosal barrier injury.

Biospecimen Retention:   Samples Without DNA
Bacteria growing from swab of oral cavity, sputum, skin, stool, and blood; stool and plasma samples.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children with CLABSI

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02271243

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Contact: Brooke Sens 617-919-6311

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United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Gregory Priebe, MD    617-355-7327   
Contact: Thomas Sandora, MD,MPH    617-355-3858   
Principal Investigator: Gregory Priebe, MD         
Sub-Investigator: Thomas Sandora, MD, PhD         
Sub-Investigator: Jennifer Blumenthal, MD         
Sub-Investigator: Alexander McAdam, MD         
Sponsors and Collaborators
Boston Children's Hospital
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Principal Investigator: Gregory Priebe, MD Boston Children's Hospital
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Responsible Party: Gregory Priebe, Staff Physician Critical Care & Infectious Disease, Boston Children's Hospital Identifier: NCT02271243    
Other Study ID Numbers: P00012105
First Posted: October 22, 2014    Key Record Dates
Last Update Posted: March 9, 2022
Last Verified: March 2022
Keywords provided by Gregory Priebe, Boston Children's Hospital:
Central line-associated bloodstream infections
mucosal barrier injury
laboratory-confirmed bloodstream infection
Additional relevant MeSH terms:
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Communicable Diseases
Disease Attributes
Pathologic Processes
Systemic Inflammatory Response Syndrome