NCT02777632

Brief Summary

The purpose of this work was to study the incidence, types, risk factors and causative organisms of bacterial infections in HCV Egyptian patients following Liver Transplantation. Moreover, to identify the emerging resistant strains and their proper antimicrobial therapy

Trial Health

100
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2014

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 19, 2016

Completed
Last Updated

February 6, 2017

Status Verified

February 1, 2017

Enrollment Period

1.8 years

First QC Date

May 17, 2016

Last Update Submit

February 2, 2017

Conditions

Transplantation Infection

Outcome Measures

Primary Outcomes (2)

  • Determine the types of early bacterial infections following LDLT, recurrent and resistant infections all were confirmed by cultures.

    Bile, abdominal drains, blood stream infection, urinary tract infection or chest infection.

    Within the first 90 days after the operation

  • Assessment of risk factors for occurrence of recurrent bacterial infections

    Independent risk factors for infections

    The first 3 months following LDLT

Study Arms (2)

HCV patients following living donor liver transplantation

single infection episode group

Procedure: Living donor liver transplantation

patients following living donor liver transplantation

recurrent Infections episode group

Procedure: Living donor liver transplantation

Interventions

Living donor liver transplantationPROCEDURE
HCV patients following living donor liver transplantationpatients following living donor liver transplantation

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

HCV patients who underwent living donor liver transplantation at Ain Shams Center for Organ Transplantation.

You may qualify if:

  • Egyptian nationality.
  • Accepting participation in the current study and signing a written consent form
  • Age between 18-60 Years, including males and females.

You may not qualify if:

  • Patients who refused to be enrolled in the study.
  • Patients with other etiologies for end-stage liver disease (HBV, PBC…)
  • Patients with preoperative infections, infections within 48 h after transplantation or early post-operative death

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Yasmine M Massoud, MD

    Faculty of Medicine, Ain Shams University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Tropical medicine

Study Record Dates

First Submitted

May 17, 2016

First Posted

May 19, 2016

Study Start

January 1, 2014

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

February 6, 2017

Record last verified: 2017-02