ID

46170

Descripción

Principal Investigator: Gregory Storch, MD, National Institute for Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA MeSH: Fever of Unknown Origin,Viruses https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000264 Definition of the human microbiome is an important scientific priority. This study will expand the scope of the investigation to include viruses, which account for a substantial proportion of infectious disease morbidity and mortality, especially in children. The long-term goal of this project is to describe the human virome in children and to investigate its relevance to febrile illnesses in children. The project will also seek to understand the relationship of the immune system to the composition of the virome. Thus, the project's specific aims are 1) To elucidate the spectrum of viruses that can be detected using non-biased, high throughput sequencing on samples of blood, respiratory, and gastrointestinal secretions from healthy children and to use this information as a basis for understanding the role of viruses in acute febrile illnesses without an obvious source, and 2) to investigate the effect of various forms of immunosuppression on the spectrum of viruses detected in children, and to use this information as a basis for understanding the role of viruses in acute febrile illnesses occurring in these children. Our preliminary studies show that diverse viruses can be detected in children having undiagnosed fever. To carry out the specific aims, well children will be enrolled prior to having elective surgery, and febrile otherwise well children will be enrolled from the Emergency Department at St. Louis Children's Hospital. Immunocompromised children will be recruited from hematopoietic stem cell and solid organ transplant clinics, the HIV/AIDS clinic, and the rheumatology/immunology clinic from the same hospital. Children with fever will have samples obtained at the time of the febrile illness and at 1 and 6-month follow-up visits. Selected samples from each study group will be analyzed at the Genome Center at Washington University (GCWU) using next generation 454 high throughput sequencing to detect and sequence all viral sequences present. We anticipate detecting and sequencing a broad range of viruses, including previously unrecognized agents. A variety of techniques will be used to investigate the significance of viruses detected. Virus-specific PCR assays will be used to determine the frequency and extent of viruses detected by sequencing, using the full range of samples collected. Host response to the detected viruses will be investigated using serologic analysis, cytokine profiling, and microarrays to characterize host gene expression. These studies will take advantage of follow-up samples to compare the acute response with the response in the convalescent period. This study will draw upon the expertise and technological assets of one of the world's most powerful sequencing centers to provide the research community with a comprehensive sequence data base of the viruses that are present in children, which can be used to improve our understanding of the causes of febrile illnesses in young children, many of which are currently undiagnosed.

Link

dbGaP study=phs000264

Palabras clave

Versiones (3)
  1. 14/7/22 14/7/22 - Dr. Christian Niklas
  2. 12/10/22 12/10/22 - Adrian Schulz
  3. 29/1/25 29/1/25 - Akane Nishihara
Titular de derechos de autor

Gregory Storch, MD, National Institute for Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA

Subido en

29 de enero de 2025

DOI

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Licencia

Creative Commons BY 4.0
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dbGaP phs000264 The Human Virome and Febrile Illness in Children

Inglés

Eligibility Criteria

5 formularios  
Inclusion and exclusion criteria
Descripción

Inclusion and exclusion criteria

*Inclusion criteria will be listed separately for each group of subjects:*
Descripción

Inclusion criteria listed below

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1512693
Febrile otherwise-well children: Fever greater than 38°C, age 2-36 months
Descripción

Fever greater than 38 degree Celsius, age 2-36 months

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [2,1]
C0001779
UMLS CUI [3,1]
C1512693
Afebrile well children: Age 2-36 months
Descripción

Afebrile well children: Age 2-36 months

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [2,1]
C1512693
Febrile immunocompromised children: Fever greater than 38°C, and a) child with solid organ or hematopoietic stem cell transplant, or b) child followed in immunology/rheumatology clinic with congenital immunodeficiency or being treated with an immunosuppressive medication, or c) child with HIV with CD4 percentage less than 15%.
Descripción

Febrile immunocompromised children

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [1,2]
C0730400
UMLS CUI [1,3]
C0029216
UMLS CUI [2,1]
C0015967
UMLS CUI [2,2]
C0018956
UMLS CUI [2,3]
C0029216
UMLS CUI [3,1]
C0015967
UMLS CUI [3,2]
C1522577
UMLS CUI [3,3]
C0152036
UMLS CUI [3,4]
C0035452
UMLS CUI [3,5]
C0853602
UMLS CUI [4,1]
C0015967
UMLS CUI [4,2]
C1522577
UMLS CUI [4,3]
C0152036
UMLS CUI [4,4]
C0035452
UMLS CUI [4,5]
C0021079
UMLS CUI [5,1]
C0015967
UMLS CUI [5,2]
C0019682
UMLS CUI [5,3]
C0039215
UMLS CUI [5,4]
C0439165
UMLS CUI [6,1]
C1512693
Transplant recipients: Child with sold organ or hematopoietic stem cell transplant Transplant donor: Individual whose organ is being used for transplantation into a child. This can include living or cadaver donors.
Descripción

Transplant recipients or Transplant donors

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1709854
UMLS CUI [1,2]
C0029216
UMLS CUI [1,3]
C0730400
UMLS CUI [2,1]
C1709854
UMLS CUI [2,2]
C0029216
UMLS CUI [2,3]
C0472699
UMLS CUI [3,1]
C0029216
UMLS CUI [3,2]
C0029206
UMLS CUI [3,3]
C0348050
UMLS CUI [4,1]
C0029216
UMLS CUI [4,2]
C0029206
UMLS CUI [4,3]
C0524354
UMLS CUI [5,1]
C1512693
*Exclusion criteria are listed separately for each group of subjects:*
Descripción

Exclusion criteria listed below

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0680251
Febrile otherwise-well children: Presence of an immunosuppressive underlying disease, a disease requiring immunosuppressive treatment, other serious chronic disease, indwelling intravascular catheter, Inability to obtain consent
Descripción

Febrile otherwise-well children

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0008059
UMLS CUI [1,3]
C0015967
UMLS CUI [1,4]
C0277554
UMLS CUI [1,5]
C4048329
UMLS CUI [2,1]
C0680251
UMLS CUI [2,2]
C0008059
UMLS CUI [2,3]
C0015967
UMLS CUI [2,4]
C0021079
UMLS CUI [2,5]
C3146298
UMLS CUI [2,6]
C0012634
UMLS CUI [3,1]
C0680251
UMLS CUI [3,2]
C0008059
UMLS CUI [3,3]
C0015967
UMLS CUI [3,4]
C0205404
UMLS CUI [3,5]
C0008679
UMLS CUI [4,1]
C0680251
UMLS CUI [4,2]
C0008059
UMLS CUI [4,3]
C0015967
UMLS CUI [4,4]
C0439848
UMLS CUI [4,5]
C0442123
UMLS CUI [4,6]
C0085590
UMLS CUI [5,1]
C0680251
UMLS CUI [5,2]
C0008059
UMLS CUI [5,3]
C0015967
UMLS CUI [5,4]
C0021430
UMLS CUI [5,5]
C1299582
Afebrile well children: Any acute illness, Inability to obtain consent
Descripción

Afebrile well children: Any acute illness, Inability to obtain consent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0008059
UMLS CUI [1,2]
C0680251
UMLS CUI [1,3]
C0001314
UMLS CUI [2,1]
C0008059
UMLS CUI [2,2]
C0680251
UMLS CUI [2,3]
C0021430
UMLS CUI [2,4]
C1299582
Febrile immunocompromised children: Inability to obtain consent
Descripción

Febrile immunocompromised children: Inability to obtain consent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0008059
UMLS CUI [1,3]
C0015967
UMLS CUI [1,4]
C0085393
UMLS CUI [1,5]
C0021430
UMLS CUI [1,6]
C1299582
Afebrile immunocompromised children: Inability to obtain consent
Descripción

Afebrile immunocompromised children: Inability to obtain consent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0085393
UMLS CUI [1,2]
C0008059
UMLS CUI [1,3]
C0021430
UMLS CUI [1,4]
C1299582
Transplant recipients: Inability to obtain consent
Descripción

Transplant recipients: Inability to obtain consent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0029216
UMLS CUI [1,2]
C0376387
UMLS CUI [1,3]
C0021430
UMLS CUI [1,4]
C1299582
Afibrile immunocompromised children: Fever greater than 38°C, and a) child with solid organ or hematopoietic stem cell transplant, or b) child followed in immunology/rheumatology clinic with congenital immunodeficiency or being treated with an immunosuppressive medication, or c) child with HIV with CD4 percentage less than 15%.
Descripción

Afibrile immunocompromised children

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0730400
UMLS CUI [1,2]
C0029216
UMLS CUI [2,1]
C0018956
UMLS CUI [2,2]
C0029216
UMLS CUI [3,1]
C1522577
UMLS CUI [3,2]
C0152036
UMLS CUI [3,3]
C0035452
UMLS CUI [3,4]
C0853602
UMLS CUI [4,1]
C1522577
UMLS CUI [4,2]
C0152036
UMLS CUI [4,3]
C0035452
UMLS CUI [4,4]
C0021079
UMLS CUI [5,1]
C0019682
UMLS CUI [5,2]
C0039215
UMLS CUI [5,3]
C0439165
UMLS CUI [6,1]
C1512693
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Similar models

Eligibility Criteria

5 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Inclusion and exclusion criteria
Inclusion criteria listed below
Item
*Inclusion criteria will be listed separately for each group of subjects:*
boolean
C1512693 (UMLS CUI [1,1])
Fever greater than 38 degree Celsius, age 2-36 months
Item
Febrile otherwise-well children: Fever greater than 38°C, age 2-36 months
boolean
C0015967 (UMLS CUI [1,1])
C0001779 (UMLS CUI [2,1])
C1512693 (UMLS CUI [3,1])
Afebrile well children: Age 2-36 months
Item
Afebrile well children: Age 2-36 months
boolean
C0001779 (UMLS CUI [1,1])
C1512693 (UMLS CUI [2,1])
Febrile immunocompromised children
Item
Febrile immunocompromised children: Fever greater than 38°C, and a) child with solid organ or hematopoietic stem cell transplant, or b) child followed in immunology/rheumatology clinic with congenital immunodeficiency or being treated with an immunosuppressive medication, or c) child with HIV with CD4 percentage less than 15%.
boolean
C0015967 (UMLS CUI [1,1])
C0730400 (UMLS CUI [1,2])
C0029216 (UMLS CUI [1,3])
C0015967 (UMLS CUI [2,1])
C0018956 (UMLS CUI [2,2])
C0029216 (UMLS CUI [2,3])
C0015967 (UMLS CUI [3,1])
C1522577 (UMLS CUI [3,2])
C0152036 (UMLS CUI [3,3])
C0035452 (UMLS CUI [3,4])
C0853602 (UMLS CUI [3,5])
C0015967 (UMLS CUI [4,1])
C1522577 (UMLS CUI [4,2])
C0152036 (UMLS CUI [4,3])
C0035452 (UMLS CUI [4,4])
C0021079 (UMLS CUI [4,5])
C0015967 (UMLS CUI [5,1])
C0019682 (UMLS CUI [5,2])
C0039215 (UMLS CUI [5,3])
C0439165 (UMLS CUI [5,4])
C1512693 (UMLS CUI [6,1])
Transplant recipients or Transplant donors
Item
Transplant recipients: Child with sold organ or hematopoietic stem cell transplant Transplant donor: Individual whose organ is being used for transplantation into a child. This can include living or cadaver donors.
boolean
C1709854 (UMLS CUI [1,1])
C0029216 (UMLS CUI [1,2])
C0730400 (UMLS CUI [1,3])
C1709854 (UMLS CUI [2,1])
C0029216 (UMLS CUI [2,2])
C0472699 (UMLS CUI [2,3])
C0029216 (UMLS CUI [3,1])
C0029206 (UMLS CUI [3,2])
C0348050 (UMLS CUI [3,3])
C0029216 (UMLS CUI [4,1])
C0029206 (UMLS CUI [4,2])
C0524354 (UMLS CUI [4,3])
C1512693 (UMLS CUI [5,1])
Exclusion criteria listed below
Item
*Exclusion criteria are listed separately for each group of subjects:*
boolean
C0680251 (UMLS CUI [1,1])
Febrile otherwise-well children
Item
Febrile otherwise-well children: Presence of an immunosuppressive underlying disease, a disease requiring immunosuppressive treatment, other serious chronic disease, indwelling intravascular catheter, Inability to obtain consent
boolean
C0680251 (UMLS CUI [1,1])
C0008059 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,3])
C0277554 (UMLS CUI [1,4])
C4048329 (UMLS CUI [1,5])
C0680251 (UMLS CUI [2,1])
C0008059 (UMLS CUI [2,2])
C0015967 (UMLS CUI [2,3])
C0021079 (UMLS CUI [2,4])
C3146298 (UMLS CUI [2,5])
C0012634 (UMLS CUI [2,6])
C0680251 (UMLS CUI [3,1])
C0008059 (UMLS CUI [3,2])
C0015967 (UMLS CUI [3,3])
C0205404 (UMLS CUI [3,4])
C0008679 (UMLS CUI [3,5])
C0680251 (UMLS CUI [4,1])
C0008059 (UMLS CUI [4,2])
C0015967 (UMLS CUI [4,3])
C0439848 (UMLS CUI [4,4])
C0442123 (UMLS CUI [4,5])
C0085590 (UMLS CUI [4,6])
C0680251 (UMLS CUI [5,1])
C0008059 (UMLS CUI [5,2])
C0015967 (UMLS CUI [5,3])
C0021430 (UMLS CUI [5,4])
C1299582 (UMLS CUI [5,5])
Afebrile well children: Any acute illness, Inability to obtain consent
Item
Afebrile well children: Any acute illness, Inability to obtain consent
boolean
C0008059 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
C0001314 (UMLS CUI [1,3])
C0008059 (UMLS CUI [2,1])
C0680251 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C1299582 (UMLS CUI [2,4])
Febrile immunocompromised children: Inability to obtain consent
Item
Febrile immunocompromised children: Inability to obtain consent
boolean
C0680251 (UMLS CUI [1,1])
C0008059 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,3])
C0085393 (UMLS CUI [1,4])
C0021430 (UMLS CUI [1,5])
C1299582 (UMLS CUI [1,6])
Afebrile immunocompromised children: Inability to obtain consent
Item
Afebrile immunocompromised children: Inability to obtain consent
boolean
C0085393 (UMLS CUI [1,1])
C0008059 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C1299582 (UMLS CUI [1,4])
Transplant recipients: Inability to obtain consent
Item
Transplant recipients: Inability to obtain consent
boolean
C0029216 (UMLS CUI [1,1])
C0376387 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C1299582 (UMLS CUI [1,4])
Afibrile immunocompromised children
Item
Afibrile immunocompromised children: Fever greater than 38°C, and a) child with solid organ or hematopoietic stem cell transplant, or b) child followed in immunology/rheumatology clinic with congenital immunodeficiency or being treated with an immunosuppressive medication, or c) child with HIV with CD4 percentage less than 15%.
boolean
C0730400 (UMLS CUI [1,1])
C0029216 (UMLS CUI [1,2])
C0018956 (UMLS CUI [2,1])
C0029216 (UMLS CUI [2,2])
C1522577 (UMLS CUI [3,1])
C0152036 (UMLS CUI [3,2])
C0035452 (UMLS CUI [3,3])
C0853602 (UMLS CUI [3,4])
C1522577 (UMLS CUI [4,1])
C0152036 (UMLS CUI [4,2])
C0035452 (UMLS CUI [4,3])
C0021079 (UMLS CUI [4,4])
C0019682 (UMLS CUI [5,1])
C0039215 (UMLS CUI [5,2])
C0439165 (UMLS CUI [5,3])
C1512693 (UMLS CUI [6,1])
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