Pulmonary Invasive Fungal InfectionsDOMINICNCT03827694
Non-Invasive Diagnosis of Pediatric Pulmonary Invasive Mold Infections
An observational study of Pulmonary Invasive Fungal Infections and Pulmonary Invasive Aspergillosis, run by Arkansas Children's Hospital Research Institute at 33 sites in 2 countries.
Trial summary
This study will establish a non-invasive diagnostic approach and evaluate clinical outcomes for children at high-risk for pulmonary invasive fungal infection (PIFI). Read more about this study
- Who is it for?
- Ages 120 days to 21 years
- Conditions the study is for
- Pulmonary Invasive Fungal Infections, Pulmonary Invasive Aspergillosis
- What is being tested?
- Non-Invasive Testing for PIFI
- How many people
- 400 participants
- Where
- 33 sitesin 2 countries
- Study dates
- 30 Oct 2018to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 120 days to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients receiving care at a participating study site
Who may be able to join
- Males or females age > 120 days and < 22 years at any participating site
- Have at least one of the following conditions associated with a known high incidence of IFI: hematopoietic stem cell transplantation (HSCT), aplastic anemia, bone marrow failure, primary or acquired immune deficiency, or malignancy
- New (last 96 hours) radiographic evidence of at least one of the following: at least one nodular lesion greater than or equal to 5 mm in size, a wedge-shaped and segmental or lobar consolidation, a cavitary lesion, a lesion with a halo sign, a lesion with a reverse halo sign, or a lesion with an air crescent sign
- Prolonged neutropenia (absolute neutrophil count < 500 cells/µl for a period of ≥ 5 consecutive days) in 30 days prior to and including the day of qualifying chest MRI or CT scan date OR currently receiving systemic therapy for acute or chronic graft-versus-host disease (GVHD) OR presence of neutrophil dysfunction because of underlying acquired or primary immune deficiency (e.g. chronic granulomatous disease) on the date of the qualifying chest MRI or CT scan
- Subject consent or parental/guardian permission (informed consent) and if appropriate, child assent
Who cannot join
- Weight <3 kg, so as to not exceed 3 ml/kg in a single blood draw
- Previous inclusion in this study
Trial locations and contacts
33 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
33 sites in 2 countries
United States32 sites, 27 recruiting
- Recruiting
Emory University-Children's Healthcare of Atlanta (CHOA)
Atlanta, Georgia, 30322
- Recruiting
Ascension Seton Medical Center
Austin, Texas, 78705
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02241
- Recruiting
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
- Recruiting
University of Chicago Medicine, Comer Children's
Chicago, Illinois, 60637
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
- Withdrawn
Cleveland Clinic
Cleveland, Ohio, 44195
- Recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43205-2664
- Recruiting
University of Texas Southwest Medical Center (UTSW)
Dallas, Texas, 75390
- Active, not recruiting
Duke University Medical Center
Durham, North Carolina, 27710
- Recruiting
MD Anderson
Houston, Texas, 77030
- Recruiting
Indiana University School of Medicine
Indianapolis, Indiana, 46202
- Recruiting
Children's Mercy
Kansas City, Missouri, 64108
- Recruiting
Rady Children's Hospital, UCSD
La Jolla, California, 92093
- Recruiting
Arkansas Children's Research Institute
Little Rock, Arkansas, 72202
- Recruiting
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
- Active, not recruiting
University of Minnesota Medical School
Minneapolis, Minnesota, 55455
- Recruiting
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232
- Recruiting
Yale University
New Haven, Connecticut, 06520
- Recruiting
Weil Cornell Medical College
New York, New York, 10021
- Recruiting
Children's Omaha
Omaha, Nebraska, 68114
- Recruiting
Children's Hospital of Orange County
Orange, California, 92868
- Recruiting
Lucile Packard Children's Hospital, Stanford University
Palo Alto, California, 94305
- Recruiting
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19146
- Recruiting
Oregon Health and Science University
Portland, Oregon, 97239
- Recruiting
Children's Minnesota
Saint Paul, Minnesota, 55102
- Withdrawn
University of California San Francisco, Benioff Children's Hospital
San Francisco, California, 94143
- Recruiting
Seattle Children's Research Institute
Seattle, Washington, 98105
- Recruiting
The Washington University
St Louis, Missouri, 63110
- Active, not recruiting
All Children's Research Institute
St. Petersburg, Florida, 33701
- Recruiting
Children's National Hospital
Washington D.C., District of Columbia, 20010-2916
Canada1 site, 1 recruiting
- Recruiting
The Hospital for Sick Children
Toronto, Ontario, M5G 1E8
About this study
This study will establish a non-invasive diagnostic approach and evaluate clinical outcomes for children at high-risk for pulmonary invasive fungal infection (PIFI).
- Being tested
- Non-Invasive Testing for PIFI
- Medical subject headings
- Invasive Pulmonary Aspergillosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Invasive Testing for PIFIDiagnostic test
galactomannan assay, fungal PCRs, cell-free next-generation DNA/RNA sequencing, RNAseq
| Study group | Role | What they receive |
|---|---|---|
| Patients with possible PIFI | Not described Receives: Diagnostic Test: Non-Invasive Testing for PIFI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Likelihood ratio of the galactomannan assay to return a positive result among subjects determined to have PIFI
Measured: Baseline
Likelihood ratio of galactomannan assay to return a negative result among subjects determined not to have PIFI
Measured: Baseline
Likelihood ratio of fungal PCRs (Aspergillus PCR, Mucorales PCR) to return a positive result among subjects determined to have PIFI
Measured: Baseline
Likelihood ratio of fungal PCRs (Aspergillus PCR, Mucorales PCR) to return a negative result among subjects determined not to have PIFI
Measured: Baseline
Likelihood ratio of cell-free next generation DNA/RNA sequencing identifying a fungal pathogen to return a positive result among subjects determined to have PIFI
Measured: Baseline
Likelihood ratio of cell-free next generation DNA/RNA sequencing identifying a fungal pathogen to return a negative result among subjects determined not to have PIFI
Measured: Baseline
Likelihood ratio of molecular RNAseq platform assessing host immune response to return a positive result among subjects determined to have PIFI
Measured: Baseline
Likelihood ratio of molecular RNAseq platform assessing host immune response to return a negative result among subjects determined not to have PIFI
Measured: Baseline
Secondary outcomes (1)
Composite outcome score between patients with possible pulmonary invasive fungal infection managed with empirical antifungal therapy versus an invasive diagnostic procedure
Outcome score inclusive of outcomes and adverse events. Comprehensive clinical outcome score from most to least desirable are score of 1 (survival, improvement in pulmonary nodules, no adverse events related to anti-fungal therapy or invasive diagnostic intervention) to score of 7 (death)
Measured: 49 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start30 Oct 2018
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Invasive Fungal 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Philadelphia, National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Sponsor
- Investigators
- William Steinbach, Principal investigator, University of ArkansasBrian Fisher, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03827694
- Sponsor's protocol ID
- Pro00094558
- Other IDs
- R01AI139032
- Acronym
- DOMINIC
- Status last verified
- Sep 2024
- First submitted
- 31 Jan 2019
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Diagnosis of Pediatric Pulmonary Invasive Mold Infections
- ClinicalTrials.gov ID
- NCT03827694
- Acronym / sponsor ID
- DOMINIC / Pro00094558
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Children's Hospital of Philadelphia, National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 30 Oct 2018 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Feb 2019 (actual)
- 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 study will establish a non-invasive diagnostic approach and evaluate clinical outcomes for children at high-risk for pulmonary invasive fungal infection (PIFI).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with possible PIFI | – | Diagnostic Test: Non-Invasive Testing for PIFI |
Who may qualify
- Ages
- 120 days to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients receiving care at a participating study site
Key inclusion criteria (5 listed)
- Males or females age > 120 days and < 22 years at any participating site
- Have at least one of the following conditions associated with a known high incidence of IFI: hematopoietic stem cell transplantation (HSCT), aplastic anemia, bone marrow failure, primary or acquired immune deficiency, or malignancy
- New (last 96 hours) radiographic evidence of at least one of the following: at least one nodular lesion greater than or equal to 5 mm in size, a wedge-shaped and segmental or lobar consolidation, a cavitary lesion, a lesion with a halo sign, a lesion with a reverse halo sign, or a lesion with an air crescent sign
- Prolonged neutropenia (absolute neutrophil count < 500 cells/µl for a period of ≥ 5 consecutive days) in 30 days prior to and including the day of qualifying chest MRI or CT scan date OR currently receiving systemic therapy for acute or chronic graft-versus-host disease (GVHD) OR presence of neutrophil dysfunction because of underlying acquired or primary immune deficiency (e.g. chronic granulomatous disease) on the date of the qualifying chest MRI or CT scan
- Subject consent or parental/guardian permission (informed consent) and if appropriate, child assent
Key exclusion criteria (2 listed)
- Weight <3 kg, so as to not exceed 3 ml/kg in a single blood draw
- Previous inclusion in this study
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 |
|---|---|---|
| Non-Invasive Testing for PIFIgalactomannan assay, fungal PCRs, cell-free next-generation DNA/RNA sequencing, RNAseq | Diagnostic test | Patients with possible PIFI |
Primary outcome
Likelihood ratio of the galactomannan assay to return a positive result among subjects determined to have PIFI
Time frame: Baseline
Likelihood ratio of galactomannan assay to return a negative result among subjects determined not to have PIFI
Time frame: Baseline
Likelihood ratio of fungal PCRs (Aspergillus PCR, Mucorales PCR) to return a positive result among subjects determined to have PIFI
Time frame: Baseline
Likelihood ratio of fungal PCRs (Aspergillus PCR, Mucorales PCR) to return a negative result among subjects determined not to have PIFI
Time frame: Baseline
Likelihood ratio of cell-free next generation DNA/RNA sequencing identifying a fungal pathogen to return a positive result among subjects determined to have PIFI
Time frame: Baseline
Likelihood ratio of cell-free next generation DNA/RNA sequencing identifying a fungal pathogen to return a negative result among subjects determined not to have PIFI
Time frame: Baseline
Likelihood ratio of molecular RNAseq platform assessing host immune response to return a positive result among subjects determined to have PIFI
Time frame: Baseline
Likelihood ratio of molecular RNAseq platform assessing host immune response to return a negative result among subjects determined not to have PIFI
Time frame: Baseline
1 secondary outcome
Composite outcome score between patients with possible pulmonary invasive fungal infection managed with empirical antifungal therapy versus an invasive diagnostic procedure
Time frame: 49 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
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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.
William Steinbach principal investigator
University of Arkansas
Brian Fisher principal investigator
Children's Hospital of Philadelphia
33 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Invasive Fungal Infections and Pulmonary Invasive Aspergillosis, run by Arkansas Children's Hospital Research Institute at 33 sites in 2 countries.
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 2 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: looking for participants now, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States, Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact PFN Central Coordinator (501-364-3057, PFNClinical@uams.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Likelihood ratio of the galactomannan assay to return a positive result among subjects determined to have PIFI (time frame: Baseline). The study lists 8 primary outcomes in all. 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 25 Sep 2024.