Using Microbial Genomics to Elucidate the Source of Central-line Associated Bloodstream Infections
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ClinicalTrials.gov Identifier: NCT02271243 |
Recruitment Status :
Recruiting
First Posted : October 22, 2014
Last Update Posted : January 10, 2024
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Condition or disease |
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Laboratory-confirmed Bloodstream Infection Central Line-associated Bloodstream Infections Mucosal Barrier Injury |
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 2024 |
Estimated Study Completion Date : | December 2025 |
Group/Cohort |
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Subject with suspected MBI |
Subjects without suspected MBI |
- 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.
- 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
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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 |
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
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 ClinicalTrials.gov identifier (NCT number): NCT02271243
Contact: Rachel Bernier, MPH | 857-218-5348 | Rachel.Bernier@childrens.harvard.edu |
United States, Massachusetts | |
Boston Children's Hospital | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Contact: Gregory Priebe, MD 617-355-7327 Gregory.Priebe@childrens.harvard.edu | |
Contact: Thomas Sandora, MD,MPH 617-355-3858 Thomas.Sandora@childrens.harvard.edu | |
Principal Investigator: Gregory Priebe, MD | |
Sub-Investigator: Thomas Sandora, MD, PhD | |
Sub-Investigator: Jennifer Blumenthal, MD | |
Sub-Investigator: Alexander McAdam, MD |
Principal Investigator: | Gregory Priebe, MD | Boston Children's Hospital |
Responsible Party: | Gregory Priebe, Staff Physician Critical Care & Infectious Disease, Boston Children's Hospital |
ClinicalTrials.gov Identifier: | NCT02271243 |
Other Study ID Numbers: |
P00012105 |
First Posted: | October 22, 2014 Key Record Dates |
Last Update Posted: | January 10, 2024 |
Last Verified: | January 2024 |
Central line-associated bloodstream infections mucosal barrier injury laboratory-confirmed bloodstream infection |
Infections Communicable Diseases Sepsis Disease Attributes |
Pathologic Processes Systemic Inflammatory Response Syndrome Inflammation |