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Pathogen Identification in Pediatric Hematopoietic Stem Cell Transplant Patients With Suspected Lower Respiratory Tract Infection

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ClinicalTrials.gov Identifier: NCT02926612
Recruitment Status : Recruiting
First Posted : October 6, 2016
Last Update Posted : August 31, 2018
Sponsor:
Collaborator:
St. Baldrick's Foundation
Information provided by (Responsible Party):
Pediatric Blood and Marrow Transplant Foundation, Inc.

Study Description
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Brief Summary:
This is a multicenter prospective collection of leftover respiratory tract secretions, paired blood and NP swabs, and clinical circumstances from pediatric HCT patients, followed by next generation genomic sequencing, transcriptome analysis, protein biomarker measurement, and statistical modeling.

Condition or disease Intervention/treatment
Lower Respiratory Tract Infections Other: Next Generation Genomic Sequencing

Detailed Description:
This study is a multicenter cross-sectional observational analysis of unused lower respiratory tract secretions collected from children with a history of HCT who are undergoing evaluation for pulmonary complications. Patients will be screened and enrolled by study coordinators at each site, who will collect and submit biospecimens as well as patient characteristics and clinical outcomes. Metagenomic NGS will be performed on these biospecimens in an attempt to identify microbial pathogens and markers of host response to infection, including immune activation, inflammation, and cell damage. This study will then correlate these results with patient characteristics, clinical microbiology test results, and clinical outcomes in order to evaluate the utility of metagenomics NGS in improving the diagnosis of LRTI in our pediatric HCT population.
Study Design
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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pathogen Identification in Pediatric Hematopoietic Stem Cell Transplant Patients With Suspected Lower Respiratory Tract Infection
Study Start Date : June 2016
Estimated Primary Completion Date : December 2019
Groups and Cohorts
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Group/Cohort Intervention/treatment
HCT recipients ages ≤21 years
HCT recipients ages ≤21 years for whom lower respiratory secretions are being collected for direct patient care.
 Other: Next Generation Genomic Sequencing
DNA and RNA are extracted from biospecimens, amplified, sequenced, and then compared to known microbe databases, allowing for quantitative identification of non-host organisms


Outcome Measures
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Primary Outcome Measures :
  1. Evaluate and quantify the utility of NGS in improving the diagnosis of LRTI in pediatric HCT patients. [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Evaluate the utility of human gene expression profiling in improving our understanding of host-microbe interactions in infectious and alloreactive pulmonary inflammation. [ Time Frame: 3 years ]

Eligibility Criteria
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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HCT recipients ages ≤21 years for whom lower respiratory secretions are being collected for direct patient care.
Criteria

Inclusion Criteria:

  • Patients will be ≤21 years of age with a history of HCT of any type at any point in the past, and are planned to undergo clinically-indicated collection of any lower respiratory specimen, including but not limited to bronchoalveolar lavage (either via a plugged telescoping catheter such as a CombiCath, or with fiberoptic bronchoscopy) and tracheal aspirate.
  • For the purposes of this study, induced or spontaneous sputum is not considered a lower respiratory tract specimen.
  • Patients may have any underlying indication for clinical testing of lower respiratory secretions, including but not limited to suspected infection, non-infectious inflammation, obstructive or restrictive lung disease, pulmonary edema, pleural effusions, alveolar hemorrhage, aspiration, or pulmonary vascular disease.
  • Patients who have not undergone HCT but plan to undergo HCT in the future, hereafter referred to as pre-HCT patients, may also be enrolled.
  • Pre-HCT patients must have intention to undergo stem cell transplantation in the future and include but are not limited to patients with primary immunodeficiency, patients with malignancy undergoing induction or consolidation chemotherapy, and HCT patients with selected cell sources who are undergoing pre-transplant conditioning but have not yet received their cellular infusion.

Exclusion Criteria:

  • Patients will not be >21 years of age.
  • Patients who do not have a clinical indication for obtaining lower respiratory secretions for testing as part of their direct patient care will be excluded.
  • Patients who do not have sufficient respiratory secretions remaining after collection and aliquoting for indicated clinical tests ordered by the treating clinician will also be excluded.
  • Patients who undergo lower respiratory testing solely to evaluate for relapsed malignancy will be excluded.
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT02926612


Contacts
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Contact: Matthew Zinter, MD 415-683-9666 matt.zinter@ucsf.edu

Locations
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United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Matt S. Zinter, MD    415-683-9666    matt.zinter@ucsf.edu   
Contact: Kevin Magruder    415-476-3834    kevin.magruder@ucsf.edu   
Sponsors and Collaborators
Pediatric Blood and Marrow Transplant Foundation, Inc.
St. Baldrick's Foundation
Investigators
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Principal Investigator: Matthew Zinter, MD University of California, San Francisco
More Information
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Responsible Party: Pediatric Blood and Marrow Transplant Foundation, Inc.
ClinicalTrials.gov Identifier: NCT02926612    
Other Study ID Numbers: SUP1601
First Posted: October 6, 2016    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Individual patient results will be available to the patient site, but it is undecided whether or not to make these results available to everyone.
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Respiratory Tract Infections
Respiratory Tract Diseases