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Completed

NCT Number: NCT01986504

The Johns Hopkins Transplant Infectious Diseases Prospective Cohort Study

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Johns Hopkins Hospital

Baltimore, Maryland, 21205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

Primary outcomes

  1. Epidemiology and Outcomes

    Time frame: 6 years

    This protocol will enable the creation of a prospective registry of infectious complications in transplant patients, to be used for research epidemiology and outcomes, and, ultimately, to improve patient care.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2016
First posted
Nov 18, 2013
Registry last updated
Jul 19, 2016

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.

Published trials that share one or more normalized conditions with this study.