Invasive CandidiasisBIOPICNCT02220790
BIOPIC: Fungal Biomarkers for Diagnosis and Response to Therapy for Pediatric Candidemia
An observational study of Invasive Candidiasis, run by Duke University at 22 sites in 4 countries.
Trial summary
The purpose of the study is to 1) define the operating characteristics of fungal biomarker assays in pediatric patients at high-risk for developing invasive candidiasis, 2) determine the change in fungal biomarker assay results in children who develop invasive candidiasis, and 3) create a biobank of blood samples from… Read more about this study
- Who is it for?
- Ages 120 days to 18 years
- Conditions the study is for
- Invasive Candidiasis
- How many people
- 515 participants
- Where
- 22 sitesin 4 countries
- Study dates
- Jan 2015to 8 Oct 2020
- How long will I take part?
- 30 Days
- 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 120 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: This study will create an international multi-center cohort of children with new clinical concern for infection while in the hospital.
Who may be able to join
- Males or females age > 120 days and <18 years
- Have at least one of the following conditions:
- admitted to a non-neonatal ICU with any underlying disease
- being transferred imminently to a non-neonatal ICU with any underlying disease
- have gastro-intestinal insufficiency (eg. chronic short-gut syndrome) and admitted to anywhere in the hospital
- have a hematological malignancy (limited to AML, ALL, non-Hodgkin's lymphoma and myelodysplastic syndrome) and admitted to anywhere to the hospital
Show all 15Show fewer
- have a solid tumor malignancy and admitted to anywhere in the hospital
- have a solid organ transplant and be admitted to anywhere in the hospital
- have a hemopoietic stem cell or bone marrow transplant and be admitted to anywhere in the hospital
- have aplastic anemia and be admitted to anywhere in the hospital
- Have ≥ 1 central catheter (arterial or venous)
- Have ≥ 1 blood culture drawn for clinical concern of infection at time of enrollment
- Clinician initiates and/or changes any systemic antimicrobial therapy at time of enrollment
- Parental/guardian permission (informed consent) and, if appropriate, child assent.
- For Aim 2: Each of the above AND a positive blood culture or sterile site culture for Candida spp. that turns positive between day 0 and day +14.
Who cannot join
- Diagnosis of an invasive fungal disease within the 30 days prior to the blood culture drawn of clinical concern of infection.
- Previous inclusion in this study
- Weight < 4 kg (Due to constraints of no more than 3 ml/kg of blood to be drawn over an 8 week period). Subjects that fall below 4 kg during the study period that blood draws are occurring will not have more than 0.75 ml/kg of blood drawn each time.
- Patient receiving empiric anti-fungal therapy for prolonged neutropenia or fever that was started prior to the time of blood culture
- If blood cultures obtained and anti-infectives are added/changed only as part of a local protocol and not dictated by clinical concern of infection
Trial locations and contacts
22 sites in 4 countries.
22 sites in 4 countries
United States19 sites
Dell Children's Medical Center
Austin, Texas
Boston Children's Hospital
Boston, Massachusetts
Ann and Robert Lurie Children's Hospital of Chicago
Chicago, Illinois
Cincinnati Children's Medical Center
Cincinnati, Ohio
Cleveland Clinic Children's
Cleveland, Ohio
Duke University
Durham, North Carolina, 27710
Texas Children's Hospital
Houston, Texas
Children's Mercy
Kansas City, Missouri
Arkansas Children's Hospital
Little Rock, Arkansas
St Jude Children's Research Hospital
Memphis, Tennessee
Medical College of Wisconsin
Milwaukee, Wisconsin
Cohen Children's Medical Center of New York
New Hyde Park, New York
New York-Presbyterian Phyllis and David Komansky Center for Children's Health
New York, New York
Children's Hospital of Orange County
Orange, California
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania
Rady Children's Hospital
San Diego, California
UCSF Benioff Children's Hospital
San Francisco, California
All Children's Hospital
St. Petersburg, Florida
Greece1 site
3rd Department Pediatrics Aristole University School of Medicine, Hippokration Hospital
Thessaloniki
Saudi Arabia1 site
King Faisal Specialist Hospital and Research Center
Riyadh
About this study
Official title: Fungal Biomarkers for Diagnosis and Response to Therapy for Pediatric
The purpose of the study is to 1) define the operating characteristics of fungal biomarker assays in pediatric patients at high-risk for developing invasive candidiasis, 2) determine the change in fungal biomarker assay results in children who develop invasive candidiasis, and 3) create a biobank of blood samples from pediatric patients at high-risk for invasive candidiasis and those with invasive candidiasis for future testing of fungal biomarker assays and development of new fungal biomarker assays. The study will assemble a prospective cohort of pediatric patients at high-risk for developing invasive candidiasis. Blood samples for biomarker testing will be obtained at the time a patient has a clinical indication for blood culture attainment. Additional blood sampling will be performed on the sub-set of patients that are found to have invasive candidiasis. The sensitivity, specificity, PPV, and NPV of biomarker assays will be determined for each biomarker assay. No PHI will be stored in the database and limits on blood draws (3 ml/kg in an 8 week period) will be adhered to.
Read the detailed description
This study will create an international multi-center cohort of children with new clinical concern for infection while in the hospital. Sites used are part of the International Pediatric Fungal Network (ipfn.org). The study plans to prospectively enroll pediatric patients at high-risk of developing invasive candidiasis over a four year period. The study duration per subject will be up to 14 days for blood collection and 30 days for data collection from the medical record.
For the first aim, this study will assemble a prospective cohort of pediatric patients at high-risk for developing invasive candidiasis. Blood samples for biomarker testing will be obtained within 24-hours of a patient having a clinical indication for blood culture attainment. To accomplish the second aim, additional blood sampling will be performed in the sub-set of patients that are found to have invasive candidiasis. For the third aim, remnant blood samples following biomarker testing from all consenting participants will be stored in a biobank. This biobank will be used to examine future, currently undeveloped, biomarker assays in an effort to further reduce the time to diagnosis of invasive candidiasis.
- Conditions
- Invasive Candidiasis
- Keywords
- IPFN, Pediatric, Fungal, Biomarker Assays, Candida, Pediatric ICU patient
- Medical subject headings
- Candidiasis, Invasive, Torulopsis
What is being measured
The primary outcome is the main question the study is designed to answer.
NPV, PPV, sensitivity, specificity, and threshold for positive result of fungal biomarker assays
Operating characteristics of fungal biomarker assays in pediatric patients at high-risk for developing invasive candidiasis
Measured: 1 day
Secondary outcomes (1)
change in fungal biomarker assay results
Measure the change in fungal biomarker assay results in those children who developed invasive candidiasis in order to monitor their response to therapy
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2014 (estimated)
- Study startJan 2015
- Primary completion8 Oct 2020
- Study completion8 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Invasive CandidiasisStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- 515 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Philadelphia
- Responsible party
- Sponsor
- Investigators
- William J Steinbach, MD, Principal investigator, Duke UniversityBrian T Fisher, DO, MPH, MSCE, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02220790
- Sponsor's protocol ID
- Pro00056090
- Acronym
- BIOPIC
- Status last verified
- Aug 2020
- First submitted
- 15 Aug 2014
- Last updated
- 28 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fisher BT, Boge CLK, Xiao R, Shuster S, Chin-Quee D, Allen J, Shaheen S, Hayden R, Suganda S, Zaoutis TE, Chang YC, Yin DE, Huppler AR, Danziger-Isakov L, Muller WJ, Roilides E, Romero J, Sue PK, Berman D, Wattier RL, Halasa N, Pong A, Maron G, Soler-Palacin P, Hutto SC, Gonzalez BE, Salvatore CM, Rajan S, Green M, Doby Knackstedt E, Hauger SB, Steinbach WJ. Multicenter Prospective Study of Biomarkers for Diagnosis of Invasive Candidiasis in Children and Adolescents. Clin Infect Dis. 2022 Aug 25;75(2):248-259. doi: 10.1093/cid/ciab928.
PubMed 35134165
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fungal Biomarkers for Diagnosis and Response to Therapy for Pediatric
- ClinicalTrials.gov ID
- NCT02220790
- Acronym / sponsor ID
- BIOPIC / Pro00056090
- Conditions
- Invasive Candidiasis
- Keywords
- IPFN, Pediatric, Fungal, Biomarker Assays, Candida, Pediatric ICU patient
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 515 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Children's Hospital of Philadelphia
- Study start
- Jan 2015
- Primary completion
- 8 Oct 2020 (actual)
- Study completion
- 8 Oct 2020 (actual)
- First posted
- 20 Aug 2014 (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.
The purpose of the study is to 1) define the operating characteristics of fungal biomarker assays in pediatric patients at high-risk for developing invasive candidiasis, 2) determine the change in fungal biomarker assay results in children who develop invasive candidiasis, and 3) create a biobank of blood samples from pediatric patients at high-risk for invasive candidiasis and those with invasive candidiasis for future testing of fungal biomarker assays and development of new fungal biomarker assays. The study will assemble a prospective cohort of pediatric patients at high-risk for developing invasive candidiasis. Blood samples for biomarker testing will be obtained at the time a patient has a clinical indication for blood culture attainment. Additional blood sampling will be performed on the sub-set of patients that are found to have invasive candidiasis. The sensitivity, specificity, PPV, and NPV of biomarker assays will be determined for each biomarker assay. No PHI will be stored in the database and limits on blood draws (3 ml/kg in an 8 week period) will be adhered to.
Detailed description
This study will create an international multi-center cohort of children with new clinical concern for infection while in the hospital. Sites used are part of the International Pediatric Fungal Network (ipfn.org). The study plans to prospectively enroll pediatric patients at high-risk of developing invasive candidiasis over a four year period. The study duration per subject will be up to 14 days for blood collection and 30 days for data collection from the medical record.
For the first aim, this study will assemble a prospective cohort of pediatric patients at high-risk for developing invasive candidiasis. Blood samples for biomarker testing will be obtained within 24-hours of a patient having a clinical indication for blood culture attainment. To accomplish the second aim, additional blood sampling will be performed in the sub-set of patients that are found to have invasive candidiasis. For the third aim, remnant blood samples following biomarker testing from all consenting participants will be stored in a biobank. This biobank will be used to examine future, currently undeveloped, biomarker assays in an effort to further reduce the time to diagnosis of invasive candidiasis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
Who may qualify
- Ages
- 120 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- This study will create an international multi-center cohort of children with new clinical concern for infection while in the hospital.
Key inclusion criteria (15 listed)
- Males or females age > 120 days and <18 years
- Have at least one of the following conditions:
- Have ≥ 1 central catheter (arterial or venous)
- Have ≥ 1 blood culture drawn for clinical concern of infection at time of enrollment
- Clinician initiates and/or changes any systemic antimicrobial therapy at time of enrollment
Key exclusion criteria (5 listed)
- Diagnosis of an invasive fungal disease within the 30 days prior to the blood culture drawn of clinical concern of infection.
- Previous inclusion in this study
- Weight < 4 kg (Due to constraints of no more than 3 ml/kg of blood to be drawn over an 8 week period). Subjects that fall below 4 kg during the study period that blood draws are occurring will not have more than 0.75 ml/kg of blood drawn each time.
- Patient receiving empiric anti-fungal therapy for prolonged neutropenia or fever that was started prior to the time of blood culture
- If blood cultures obtained and anti-infectives are added/changed only as part of a local protocol and not dictated by clinical concern of infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
NPV, PPV, sensitivity, specificity, and threshold for positive result of fungal biomarker assays
Time frame: 1 day
Operating characteristics of fungal biomarker assays in pediatric patients at high-risk for developing invasive candidiasis
1 secondary outcome
change in fungal biomarker assay results
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2022.
- Results publication: PubMed 35134165Fisher BT, Boge CLK, Xiao R, Shuster S, Chin-Quee D, Allen J, Shaheen S, Hayden R, Suganda S, Zaoutis TE, Chang YC, Yin DE, Huppler AR, Danziger-Isakov L, Muller WJ, Roilides E, Romero J, Sue PK, Berman D, Wattier RL, Halasa N, Pong A, Maron G, Soler-Palacin P, Hutto SC, Gonzalez BE, Salvatore CM, Rajan S, Green M, Doby Knackstedt E, Hauger SB, Steinbach WJ. Multicenter Prospective Study of Biomarkers for Diagnosis of Invasive Candidiasis in Children and Adolescents. Clin Infect Dis. 2022 Aug 25;75(2):248-259. doi: 10.1093/cid/ciab928.
Related trials for Invasive Candidiasis
RecruitingObservational study
Natural History of Individuals With Immune System Problems That Lead to Fungal Infections
Chronic Mucocutaneous Candidiasis, Invasive Aspergillosis
RecruitingObservational study
Middle East Study of Infections in Patients With Hematological Malignancies
Hematological Malignancy, Hematopoetic Stem Cell Transplantation
Recruiting
Comparison of Uncomplicated Candidemia Therapy Duration in Children and Adults
Invasive Candidiasis
RecruitingPhase 3
A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Participants With Candidemia and/or Invasive Candidiasis.
Candidemia, Candidiasis, Invasive
Not yet recruitingPhase 4
Shortening Treatment Duration in Uncomplicated Candidemia: the CanTEN Trial
Candidemia, Invasive Candidiasis
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.
William J Steinbach, MD principal investigator
Duke University
Brian T Fisher, DO, MPH, MSCE principal investigator
Children's Hospital of Philadelphia
22 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Invasive Candidiasis, run by Duke University at 22 sites in 4 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 15 inclusion and 5 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: finished, as of the sponsor's last update on 28 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Greece, Saudi Arabia, Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NPV, PPV, sensitivity, specificity, and threshold for positive result of fungal biomarker assays (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02220790, which also lists 1 linked publication.
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 28 Feb 2022.