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

NCT02926612 | Unknown DMC

• 1 other identifier: SUP1601
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Respiratory Tract Infections

Outcome Measures

Primary Outcomes (1)

• Evaluate and quantify the utility of NGS in improving the diagnosis of LRTI in pediatric HCT patients.

  3 years

Secondary Outcomes (1)

• Evaluate the utility of human gene expression profiling in improving our understanding of host-microbe interactions in infectious and alloreactive pulmonary inflammation.

  3 years

Study Arms (1)

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

Interventions

Next Generation Genomic Sequencing OTHER

DNA and RNA are extracted from biospecimens, amplified, sequenced, and then compared to known microbe databases, allowing for quantitative identification of non-host organisms

HCT recipients ages ≤21 years

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

HCT recipients ages ≤21 years for whom lower respiratory secretions are being collected for direct patient care.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pediatric Blood and Marrow Transplant Foundation, Inc.: lead
• St. Baldrick's Foundation: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

Study Officials

• Matthew Zinter, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew Zinter, MD

CONTACT

415-683-9666; matt.zinter@ucsf.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2016
• First Posted: October 6, 2016
• Study Start: June 1, 2016
• Primary Completion: December 1, 2019
• Last Updated: August 31, 2018

Record last verified: 2018-08

Locations

US (1)