Respiratory Viral Infections in Pediatric Transplantation
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease, Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | Any - 18 |
| Updated: | 4/21/2016 |
| Start Date: | September 2014 |
| End Date: | August 2015 |
A Multicenter Consortium to Define the Epidemiology and Outcomes of Respiratory Viral Infections in Pediatric Transplant Recipients
A retrospective cohort of solid organ transplant (SOT) and hematopoietic stem cell
transplant (HSCT) recipients will be assembled to determine the incidence of respiratory
viral infections diagnosed during an inpatient admission in the first year post-transplant.
A sub-cohort of patients that develop a respiratory viral infection within one year of
transplantation will be leveraged to investigate factors associated with mortality in the
three months after respiratory viral infection.
transplant (HSCT) recipients will be assembled to determine the incidence of respiratory
viral infections diagnosed during an inpatient admission in the first year post-transplant.
A sub-cohort of patients that develop a respiratory viral infection within one year of
transplantation will be leveraged to investigate factors associated with mortality in the
three months after respiratory viral infection.
The purpose of the study is to 1) Determine the incidence of respiratory viral infections
diagnosed during the first year post SOT and HSCT; 2a) Determine the all-cause mortality
within 3 months of a respiratory viral infection diagnosed during an inpatient admission in
the first year post SOT and HSCT; 2b) Determine the proportion of deaths within 3 months of
a respiratory viral infection diagnosed during an inpatient admission deemed to be directly
attributable to that infection; and 3) To identify factors known at time of onset of the
inpatient respiratory viral infection that are associated with all-cause mortality. The
study cohort will consist of any SOT or HSCT recipient ≤18 years of age that received their
transplant between January 1st, 2010 and June 30th, 2013. Th cohort will determine the
incidence of respiratory viral infections diagnosed during an inpatient admission in the
first year post-transplant. A sub-cohort of patients that develop a respiratory viral
infection within one year of transplantation will be leveraged to investigate factors
associated with mortality in the 3 months after respiratory viral infection. Baseline and
demographic characteristics will be summarized by standard descriptive summaries.
Categorical variables will be summarized by frequencies while continuous variables will be
summarized using mean, standard deviation and/or median, twenty-fifth and seventy-fifth
percentiles, minimum, and maximum. This is a minimal risk study using data that will be
collected retrospectively from medical charts. The only potential risk would be loss of
confidentiality.
diagnosed during the first year post SOT and HSCT; 2a) Determine the all-cause mortality
within 3 months of a respiratory viral infection diagnosed during an inpatient admission in
the first year post SOT and HSCT; 2b) Determine the proportion of deaths within 3 months of
a respiratory viral infection diagnosed during an inpatient admission deemed to be directly
attributable to that infection; and 3) To identify factors known at time of onset of the
inpatient respiratory viral infection that are associated with all-cause mortality. The
study cohort will consist of any SOT or HSCT recipient ≤18 years of age that received their
transplant between January 1st, 2010 and June 30th, 2013. Th cohort will determine the
incidence of respiratory viral infections diagnosed during an inpatient admission in the
first year post-transplant. A sub-cohort of patients that develop a respiratory viral
infection within one year of transplantation will be leveraged to investigate factors
associated with mortality in the 3 months after respiratory viral infection. Baseline and
demographic characteristics will be summarized by standard descriptive summaries.
Categorical variables will be summarized by frequencies while continuous variables will be
summarized using mean, standard deviation and/or median, twenty-fifth and seventy-fifth
percentiles, minimum, and maximum. This is a minimal risk study using data that will be
collected retrospectively from medical charts. The only potential risk would be loss of
confidentiality.
Inclusion Criteria:
- Males or females age 0 to <18 years at the time of HSCT or SOT
- Transplantation occurred between January 1st, 2010 and June 30th, 2013.
Exclusion Criteria:
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