The Johns Hopkins Transplant Infectious Diseases Prospective Cohort Study



Status:Completed
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 100
Updated:7/20/2016
Start Date:June 2011
End Date:June 2016

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The Transplant Infectious Diseases Prospective Cohort Study facilitates the prospective
identification and collection of data of infectious disease complications in order to
determine the epidemiology, risk factors, and outcomes of patients who receive solid organ
or stem cell or plastic surgery transplants at Johns Hopkins and other transplant centers.
It is essential for the care and treatment of this population to employ a mechanism for
investigators to centralize these datasets, using standardized definitions of infectious
complications. This protocol outlines the procedures to be utilized in order to
prospectively follow the diagnosis and treatment of infectious complications in transplant
patients.

Patients are approached at their transplant screening visit, if possible, or during their
hospital stay (before or after transplant) in order to introduce the study and obtain
informed consent for participation. A letter to transplant physicians will introduce this
study. Data collection will begin immediately upon consent and continue for up to five
years. The informed consent form specifically requests permission to contact the subject in
the future to verify information or if the subject is lost to follow up by Transplant
services.

The Day of transplant will be considered day 0 for enrollment in this observational study.
Data will be collected on clinical template forms completed by study team members, as
infectious complications become apparent in either outpatient ID clinics or on the inpatient
service. A member of the research team will complete data collection in the registry,
maintained on the REDCap platform. In addition, patient electronic records will be reviewed
every 3 months to identify and record infectious complications, treatments administered, and
outcomes. During these intervals, subjects will be contacted by phone to review the same
outcomes.

Creation of the registry relies on use of standardized definitions to define infections. An
electronic database has been constructed in the REDCap system, documenting subject
demographics, transplant variables, infection variables, treatments administered, and
overall outcomes, during each interim time period.

Inclusion Criteria:

Hematopoietic stem cell (bone marrow) and solid organ transplant patients -

Exclusion Criteria:
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1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
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