Undiagnosed Hepatitis C Infection in an Urban Hospital

Hepatitis C Clinical Trial

Official title:

Incidence of Undiagnosed Hepatitis C Infection in an Urban Hospital

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01957085
• Other study ID #: Undiagnosed Hepatitis C
• Status: Completed
• Start date: June 2014
• Est. completion date: January 2016

Study information

• Verified date: April 2020
• Source: Temple University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The Centers for Disease Control and Prevention estimates that there are approximately 3.2 million people in the United States infected with hepatitis C and a significant percentage of these patients are unaware of their diagnosis. This study will attempt to determine the point prevalence of undiagnosed hepatitis C infection in an urban hospital population. All patients admitted to the hospital on two separate days will have hepatitis C testing done on leftover serum and plasma that was collected as part of routine inpatient lab work. Our primary goal is to determine the number of undiagnosed hepatitis C infected patients in our hospitalized population. We will also compare these rates to specific demographic characteristics, such as age, race, gender, zip code and type of insurance to see if any associations exist between these demographics and undiagnosed hepatitis C infection.

Description:

De-identified study of Hepatitis C infection point prevalence in the inpatient setting of an inner city hospital.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 366
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient admitted to Temple University Hospital on either of the study dates

Exclusion Criteria:

• Patients admitted on both study dates will only be counted once

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Other:
• observation only
This is an observational only, nonintervention study. There will be no patient contact. This was a de-identified point prevalence study of hepatitis C infection in hospitalized patients in an inner city hospital.

Locations

Country	Name	City	State
United States	Temple University Hospital	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Temple University	Janssen Services, LLC

Country where clinical trial is conducted

United States, 

References & Publications (3)

Brady KA, Weiner M, Turner BJ. Undiagnosed hepatitis C on the general medicine and trauma services of two urban hospitals. J Infect. 2009 Jul;59(1):62-9. doi: 10.1016/j.jinf.2009.04.008. Epub 2009 May 3. — View Citation

Ly KN, Xing J, Klevens RM, Jiles RB, Ward JW, Holmberg SD. The increasing burden of mortality from viral hepatitis in the United States between 1999 and 2007. Ann Intern Med. 2012 Feb 21;156(4):271-8. doi: 10.7326/0003-4819-156-4-201202210-00004. Erratum in: Ann Intern Med. 2012 Jun 5;156(11):840. — View Citation

Seamon MJ, Ginwalla R, Kulp H, Patel J, Pathak AS, Santora TA, Gaughan JP, Goldberg AJ, Tedaldi EM. HIV and hepatitis in an urban penetrating trauma population: unrecognized and untreated. J Trauma. 2011 Aug;71(2):306-10; discussion 311. doi: 10.1097/TA.0b013e31822178bd. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Evaluable Participants Age 50 or Older and Point Prevalence of Hepatitis C Viremia	Association between point prevalence of hepatitis C viremia and evaluable participants age 50 or older.	Single 24 hour period
Other	Number of Evaluable Patients With Hepatitis C Viremia by Gender	Association between the incidence of hepatitis C infection and gender.	Single 24 hour period
Other	Number of Patients With Hepatitis C Viremia by Race and Ethnicity	Association between the incidence of hepatitis C infection by race and ethnicity	Single 24 hour period
Other	Association Between Evaluable Viremic Patients and Length of Stay in the Hospital	Association between hepatitis C infection and the patient's length of stay in the hospital.	Single 24 hour period
Other	Number of Evaluable Patients by Prior Visits to the Health System	Number of evaluable patients with at least one prior health system visit in the past 3 years by hepatitis C viremia	Single 24 hour period
Primary	Point Prevalence of Hepatitis C Infection	The point prevalence of hepatitis C infection in our hospitalized patients will be measured on a single day. All leftover plasma/serum samples will be de-identified and tested for hepatitis C antibody and if antibody positive will be tested for hepatitis C polymerase chain reaction. Results reported as percentage of subjects who are viremic.	Single 24 hour period