Resistant Bacterial Infections in the Early Post LDLT Period

February 2, 2017 updated by: Yasmine Mahmoud Aly Massoud, Ain Shams University
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This prospective descriptive study has been done at Tropical Medicine department in the period between January 2014 to November 2015.

After the approval of the scientific and ethical committee of Ain Shams University Hospital, Patients with HCV positive end stage liver disease (ESLD) eligible for liver transplantation Ain Shams Center for Organ Transplant (ASCOT); Ain Shams University, (fulfilling the inclusion criteria) were included in the current study. Forty five patients were recruited and each one was followed-up during a period of 3 months following transplantation.

Included patients were divided into 2 groups:

Group 1 included patients who had a postoperative single episode of infection. Group 2 included those patients who had more than 1 episode of postoperative bacterial infection whom were further evaluated for the presence of emerging strains and/or antibiotic resistance.

Study Type

Observational

Enrollment (Actual)

45

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine the types of early bacterial infections following LDLT, recurrent and resistant infections all were confirmed by cultures.
Time Frame: Within the first 90 days after the operation
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
Time Frame: The first 3 months following LDLT
Independent risk factors for infections
The first 3 months following LDLT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: Yasmine M Massoud, MD, Faculty of Medicine, Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

May 17, 2016

First Submitted That Met QC Criteria

May 17, 2016

First Posted (Estimate)

May 19, 2016

Study Record Updates

Last Update Posted (Estimate)

February 6, 2017

Last Update Submitted That Met QC Criteria

February 2, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2652010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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