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Respiratory Viral Infections in Pediatric Transplantation

A Multicenter Consortium to Define the Epidemiology and Outcomes of Respiratory Viral Infections in Pediatric Transplant Recipients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02260596
Enrollment
2669
Registered
2014-10-09
Start date
2014-09-30
Completion date
2015-08-31
Last updated
2015-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complications of Organ Transplant, Infection in Solid Organ Transplant Recipients, Respiratory Viral Infection

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

University of Washington
CollaboratorOTHER
Children's Hospital of Philadelphia
CollaboratorOTHER
Albert Einstein College of Medicine
CollaboratorOTHER
Baylor College of Medicine
CollaboratorOTHER
St. Jude Children's Research Hospital
CollaboratorOTHER
University of Cincinnati
CollaboratorOTHER
University of Pittsburgh
CollaboratorOTHER
Duke University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

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

* None

Design outcomes

Primary

MeasureTime frameDescription
Incidence of respiratory viral infection1 year post transplantPediatric SOT/HSCT recipients who do not develop respiratory viral infection within 1 year following transplant

Secondary

MeasureTime frameDescription
All-cause mortality of respiratory viral infection3 months after respiratory viral infectionDetermine 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.

Other

MeasureTime frameDescription
Factors associated with all-cause mortality of respiratory viral infection3 months after respiratory viral infectionThis tertiary aim will include just those patients that had an inpatient respiratory viral infection. The analysis will explore the association of factors known at time of onset of the respiratory viral infection with 3 month all-cause mortality

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026