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Completed

NCT Number: NCT02260596

Respiratory Viral Infections in Pediatric Transplantation

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.

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Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Incidence of respiratory viral infection

    Time frame: 1 year post transplant

    Pediatric SOT/HSCT recipients who do not develop respiratory viral infection within 1 year following transplant

Secondary outcomes

  1. All-cause mortality of respiratory viral infection

    Time frame: 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.

Other outcomes

  1. Factors associated with all-cause mortality of respiratory viral infection

    Time frame: 3 months after 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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 9, 2014
Registry last updated
Dec 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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