Respiratory Viral Infections in Pediatric Transplantation

Completed

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

• Registration Number: NCT02260596
• Lead Sponsor: Duke University

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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-29
• Study First Submitted QC: 2014-10-08
• Study First Posted: 2014-10-09
• Status Verified: 2015-07
• Primary Completion: 2015-07
• Study Completion: 2015-08
• Last Update Submitted: 2015-12-14
• Last Update Posted: 2015-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2669

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.

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Exclusion Criteria

• None

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of respiratory viral infection	1 year post transplant	Pediatric SOT/HSCT recipients who do not develop respiratory viral infection within 1 year following transplant

Secondary Outcome Measures

Name	Time	Method
All-cause mortality of respiratory viral infection	3 months after 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.

Trial Locations

Locations (1)

Duke University; 🇺🇸 Durham, North Carolina, United States