Respiratory Viral Infections in Pediatric Transplantation

Respiratory Viral Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02260596
• Other study ID #: Pro00056727
• Status: Completed
• Phase: N/A
• First received: September 29, 2014
• Last updated: December 14, 2015
• Start date: September 2014
• Est. completion date: August 2015

Study information

• Verified date: July 2015
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2669
• Est. completion date: August 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Communicable Diseases
• Complications of Organ Transplant
• Infection
• Infection in Solid Organ Transplant Recipients
• Respiratory Viral Infection
• Virus Diseases

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (8)

Lead Sponsor	Collaborator
Duke University	Albert Einstein College of Medicine of Yeshiva University, Baylor College of Medicine, Children's Hospital of Philadelphia, St. Jude Children's Research Hospital, University of Cincinnati, University of Pittsburgh, University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	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	No
Secondary	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	No