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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
Sponsor:
Information provided by (Responsible Party):
Kieren Marr, Johns Hopkins University

Brief Summary:
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.

Condition or disease
Transplantation

Detailed Description:

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 1058 participants
Observational Model: Cohort
Time Perspective: Prospective
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



Primary Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Hematopoietic stem cell (bone marrow) and solid organ transplant patients
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-


Information from the National Library of Medicine

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


Locations
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United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
Additional Information:

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Responsible Party: Kieren Marr, Professor of Medicine, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01986504    
Other Study ID Numbers: NA_00044645
First Posted: November 18, 2013    Key Record Dates
Last Update Posted: July 19, 2016
Last Verified: July 2016
Keywords provided by Kieren Marr, Johns Hopkins University:
Infection
Cohort
Prospective
Epidemiology
Outcome
Additional relevant MeSH terms:
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Communicable Diseases
Infection