Clinical trial NCT02260596: Respiratory Viral Infections in Pediatric Transplantation
Official title: A Multicenter Consortium to Define the Epidemiology and Outcomes of Respiratory Viral Infections in Pediatric Transplant Recipients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infection in Solid Organ Transplant Recipients
Complications of Organ Transplant
Respiratory Viral Infection
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: University of Washington
name: Children's Hospital of Philadelphia
name: Albert Einstein College of Medicine
name: Baylor College of Medicine
name: St. Jude Children's Research Hospital
name: University of Cincinnati
name: University of Pittsburgh
First posted: 2014-10-09
Enrollment: 2669
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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. Participants will have information collected from 30 days prior to transplant until the first of the following: 365 days post receipt of transplant, death, or loss to follow-up. If a patient has more than one viral respiratory infection of the same pathogen during the study period, then only the first infection will be considered unless isolated at least one month after the first positive test and only if after at least two negative tests for that same virus. A patient can contribute more than one viral respiratory infection if they are caused by different viral pathogens.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of respiratory viral infection
timeFrame: 1 year post transplant
Secondary outcomes:
measure: All-cause mortality of respiratory viral infection
timeFrame: 3 months after respiratory viral infection
Other outcomes:
measure: Factors associated with all-cause mortality of respiratory viral infection
timeFrame: 3 months after respiratory viral infection
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: William J Steinbach, MD
role: PRINCIPAL_INVESTIGATOR
References: