Pathogen Identification in Pediatric Hematopoietic Stem Cell Transplant Patients With Suspected Lower Respiratory Tract Infection
![]() |
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. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02926612 |
Recruitment Status : Unknown
Verified August 2018 by Pediatric Blood and Marrow Transplant Foundation, Inc..
Recruitment status was: Recruiting
First Posted : October 6, 2016
Last Update Posted : August 31, 2018
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
Lower Respiratory Tract Infections | Other: Next Generation Genomic Sequencing |
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 |
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 |
- Evaluate and quantify the utility of NGS in improving the diagnosis of LRTI in pediatric HCT patients. [ Time Frame: 3 years ]
- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | up to 21 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.

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
Contact: Matthew Zinter, MD | 415-683-9666 | matt.zinter@ucsf.edu |
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 |
Principal Investigator: | Matthew Zinter, MD | University of California, San Francisco |
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. |
Infections Communicable Diseases Respiratory Tract Infections |
Disease Attributes Pathologic Processes Respiratory Tract Diseases |