BIOPIC: Fungal Biomarkers for Diagnosis and Response to Therapy for Pediatric Candidemia (BIOPIC)
|
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: NCT02220790 |
|
Recruitment Status :
Completed
First Posted : August 20, 2014
Last Update Posted : February 28, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease |
|---|
| Invasive Candidiasis |
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 Type : | Observational [Patient Registry] |
| Actual Enrollment : | 515 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 30 Days |
| Official Title: | Fungal Biomarkers for Diagnosis and Response to Therapy for Pediatric |
| Study Start Date : | January 2015 |
| Actual Primary Completion Date : | October 8, 2020 |
| Actual Study Completion Date : | October 8, 2020 |
- 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
- change in fungal biomarker assay results [ Time Frame: 14 days ]Measure the change in fungal biomarker assay results in those children who developed invasive candidiasis in order to monitor their response to therapy
Biospecimen Retention: Samples With DNA
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: | 120 Days to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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
- 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.
Exclusion Criteria:
- 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
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): NCT02220790
Show 22 study locations
| Principal Investigator: | William J Steinbach, MD | Duke University | |
| Principal Investigator: | Brian T Fisher, DO, MPH, MSCE | Children's Hospital of Philadelphia |
Publications of Results:
| Responsible Party: | Duke University |
| ClinicalTrials.gov Identifier: | NCT02220790 |
| Other Study ID Numbers: |
Pro00056090 |
| First Posted: | August 20, 2014 Key Record Dates |
| Last Update Posted: | February 28, 2022 |
| Last Verified: | August 2020 |
|
IPFN Pediatric Fungal |
Biomarker Assays Candida Pediatric ICU patient |
|
Candidiasis Candidiasis, Invasive Mycoses |
Bacterial Infections and Mycoses Infections Invasive Fungal Infections |