Respiratory Viral Infections in Pediatric Transplantation

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Viral Infection; Infection in Solid Organ Transplant Recipients; Complications of Organ Transplant

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.

• Study Type: Observational
• Enrollment (Actual): 2669

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cohort Population; Pediatric SOT/HSCT recipients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of respiratory viral infection	Pediatric SOT/HSCT recipients who do not develop respiratory viral infection within 1 year following transplant	1 year post transplant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality of respiratory viral infection	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.	3 months after respiratory viral infection

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Factors associated with all-cause mortality of respiratory viral infection	This 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	3 months after respiratory viral infection

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Baylor College of Medicine; Children's Hospital of Philadelphia; Albert Einstein College of Medicine; University of Pittsburgh; University of Washington; St. Jude Children's Research Hospital; University of Cincinnati

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: September 29, 2014
• First Submitted That Met QC Criteria: October 8, 2014
• First Posted (Estimate): October 9, 2014

Study Record Updates

• Last Update Posted (Estimate): December 16, 2015
• Last Update Submitted That Met QC Criteria: December 14, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Virus Diseases
• Other Study ID Numbers: Pro00056727