Respiratory Viral Infections in Pediatric Transplantation

NCT02260596 | Completed DMC

• 1 other identifier: Pro00056727
• Study Type: observational
• Target: 2,669
• Locations: 1 country
• Sites: 1

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.

Conditions

Infection in Solid Organ Transplant Recipients; Complications of Organ Transplant; Respiratory Viral Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• All-cause mortality of respiratory viral infection

  3 months after respiratory viral infection

Other Outcomes (1)

• Factors associated with all-cause mortality of respiratory viral infection

  3 months after respiratory viral infection

Study Arms (1)

Cohort Population

Pediatric SOT/HSCT recipients

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

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

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

Location

Study Officials

• William J Steinbach, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2014
• First Posted: October 9, 2014
• Study Start: September 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: August 1, 2015
• Last Updated: December 16, 2015

Record last verified: 2015-07

Locations

US (1)