Laboratory-confirmed Bloodstream InfectionNCT02271243
Using Microbial Genomics to Elucidate the Source of Central-line Associated Bloodstream Infections
An observational study of Laboratory-confirmed Bloodstream Infection and Central Line-associated Bloodstream Infections, run by Boston Children's Hospital at 1 site in United States.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Laboratory-confirmed Bloodstream Infection, Central Line-associated Bloodstream Infections, Mucosal Barrier Injury
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Children with CLABSI
Who may be able to join
- 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
Who cannot join
- Patients with CDC-defined secondary bloodstream infections
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Gregory Priebe, MD, 617-355-7327, Gregory.Priebe@childrens.harvard.edu
Thomas Sandora, MD,MPH, 617-355-3858, Thomas.Sandora@childrens.harvard.edu
About this study
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.
Read the 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.
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Subject with suspected MBI | Not described | |
| Subjects without suspected MBI | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2014 (estimated)
- Study startNov 2014
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laboratory-confirmed Bloodstream InfectionStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gregory Priebe, Boston Children's Hospital
- Investigators
- Gregory Priebe, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02271243
- Sponsor's protocol ID
- P00012105
- Status last verified
- May 2026
- First submitted
- 17 Oct 2014
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Microbial Genomics to Elucidate the Source of Central-line Associated Bloodstream Infections
- ClinicalTrials.gov ID
- NCT02271243
- Acronym / sponsor ID
- P00012105
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- Nov 2014 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 22 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subject with suspected MBI | – | – |
| Subjects without suspected MBI | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Children with CLABSI
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Patients with CDC-defined secondary bloodstream infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Levels of biomarkers of MBI in the blood and stool (citrulline in blood, calprotectin in stool)
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gregory Priebe, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Laboratory-confirmed Bloodstream Infection and Central Line-associated Bloodstream Infections, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel Bernier, MPH (857-218-5348, Rachel.Bernier@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phylogenetic relationships (on SNP scale) of bacteria isolated from different body sites (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.