Lower Respiratory Tract InfectionsNCT02926612
Pathogen Identification in Pediatric Hematopoietic Stem Cell Transplant Patients With Suspected Lower Respiratory Tract Infection
An observational study of Lower Respiratory Tract Infections, run by Pediatric Blood and Marrow Transplant Foundation, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Lower Respiratory Tract Infections
- What is being tested?
- Next Generation Genomic Sequencing
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: HCT recipients ages ≤21 years for whom lower respiratory secretions are being collected for direct patient care.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
Matt S. Zinter, MD, 415-683-9666, matt.zinter@ucsf.edu
Kevin Magruder, 415-476-3834, kevin.magruder@ucsf.edu
About this study
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.
Read the 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.
- Conditions
- Lower Respiratory Tract Infections
- Being tested
- Next Generation Genomic Sequencing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Next Generation Genomic SequencingOther
DNA and RNA are extracted from biospecimens, amplified, sequenced, and then compared to known microbe databases, allowing for quantitative identification of non-host organisms
| Study group | Role | What they receive |
|---|---|---|
| HCT recipients ages ≤21 years | HCT recipients ages ≤21 years for whom lower respiratory secretions are being collected for direct patient care. Receives: Other: Next Generation Genomic Sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate and quantify the utility of NGS in improving the diagnosis of LRTI in pediatric HCT patients.
Measured: 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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Respiratory Tract InfectionsStudies of the same condition, open and under way.
- 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pediatric Blood and Marrow Transplant Foundation, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- St. Baldrick's Foundation
- Responsible party
- Sponsor
- Investigators
- Matthew Zinter, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02926612
- Sponsor's protocol ID
- SUP1601
- Status last verified
- Aug 2018
- First submitted
- 4 Oct 2016
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: Individual patient results will be available to the patient site, but it is undecided whether or not to make these results available to everyone.
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathogen Identification in Pediatric Hematopoietic Stem Cell Transplant Patients With Suspected Lower Respiratory Tract Infection
- ClinicalTrials.gov ID
- NCT02926612
- Acronym / sponsor ID
- SUP1601
- Conditions
- Lower Respiratory Tract Infections
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Pediatric Blood and Marrow Transplant Foundation, Inc.University, hospital or other
- Collaborators
- St. Baldrick's Foundation
- Study start
- Jun 2016
- Primary completion
- Dec 2019 (estimated)
- First posted
- 6 Oct 2016 (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.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HCT recipients ages ≤21 years | – | Other: Next Generation Genomic SequencingHCT recipients ages ≤21 years for whom lower respiratory secretions are being collected for direct patient care. |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- HCT recipients ages ≤21 years for whom lower respiratory secretions are being collected for direct patient care.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Next Generation Genomic SequencingDNA and RNA are extracted from biospecimens, amplified, sequenced, and then compared to known microbe databases, allowing for quantitative identification of non-host organisms | Other | HCT recipients ages ≤21 years |
Primary outcome
Evaluate and quantify the utility of NGS in improving the diagnosis of LRTI in pediatric HCT patients.
Time frame: 3 years
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
- Individual participant dataSharing planned: Undecided. Individual patient results will be available to the patient site, but it is undecided whether or not to make these results available to everyone.
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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. This study is not recruiting at the moment.
Matthew Zinter, MD principal investigator
University of California, San Francisco
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 Lower Respiratory Tract Infections, run by Pediatric Blood and Marrow Transplant Foundation, Inc. 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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 31 Aug 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matthew Zinter, MD (415-683-9666, matt.zinter@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate and quantify the utility of NGS in improving the diagnosis of LRTI in pediatric HCT patients. (time frame: 3 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 31 Aug 2018; AzTrials last refreshed its copy on 6 Nov 2026.