NCT02826447

Brief Summary

This project is a prospective observational cohort study to quantify the risk of acquiring Hepatitis C virus (HCV) infection for patients and healthcare workers in Ain Shams University Teaching Hospital, Cairo, Egypt through: 1) identifying typical patient trajectories within the hospital; and 2) assessing the ward-specific risk based on the type and number of procedures performed and the prevalence of HCV viremia in patients within each ward.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
550

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed
8 months until next milestone

Study Start

First participant enrolled

February 21, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

April 10, 2017

Status Verified

April 1, 2017

Enrollment Period

1.1 years

First QC Date

June 30, 2016

Last Update Submit

April 7, 2017

Conditions

Outcome Measures

Primary Outcomes (2)

  • Per-day risk of HCV acquisition for a hospitalized patient

    Per-day risk of HCV acquisition for a hospitalized patient

    1 day

  • Per-week risk of HCV acquisition for a healthcare worker through occupational blood exposure

    Per-week risk of HCV acquisition for a healthcare worker through occupational blood exposure

    1 week

Secondary Outcomes (1)

  • Estimation of the number of HCV acquisitions among patients and HCWs prevented over a 1-year period following the implementation of various control strategies, using a mathematical modeling approach

    1 year

Study Arms (2)

Patients

500 patients who are going to be hospitalized for at least 24 hours at Ain Shams University Teaching Hospital in the following departments: surgery, internal medicine, gynecology/obstetrics and toxicology.

Healthcare workers

50 healthcare workers working at Ain Shams University Teaching Hospital in the following departments: surgery, internal medicine, gynecology/obstetrics and toxicology.

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

500 patients staying at least 24 hours in one of the following departments of the Ain Shams University Teaching Hospital: surgery, internal medicine, gynecology/obstetrics and toxicology. 50 healthcare workers working in one of departments cited above.

You may qualify if:

  • Aged 21 years or older
  • Staying in the hospital more than 24 hours
  • Provided a written informed consent to participate
  • Aged 21 or older
  • Provided a written informed consent to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University Teaching Hospital

Cairo, Egypt

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample (5mL)

Study Officials

  • Laura Temime, Professor

    Conservatoire national des Arts et Métiers

    PRINCIPAL INVESTIGATOR
  • Wagida Anwar, Professor

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Temime, Professor

CONTACT

Wagida Anwar, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Weeks
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2016

First Posted

July 11, 2016

Study Start

February 21, 2017

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

April 10, 2017

Record last verified: 2017-04

Locations