The Johns Hopkins Transplant Infectious Diseases Prospective Cohort Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01986504|
Recruitment Status : Completed
First Posted : November 18, 2013
Last Update Posted : July 19, 2016
|Condition or disease|
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.
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||1058 participants|
|Target Follow-Up Duration:||5 Years|
|Official Title:||The Johns Hopkins Transplant Infectious Diseases Prospective Cohort Study|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2016|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01986504
|United States, Maryland|
|Johns Hopkins Hospital|
|Baltimore, Maryland, United States, 21205|