Resistant Bacterial Infections in the Early Post LDLT Period

• Sponsor: Ain Shams University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02777632
• Collaborator: (none)
• Enrollment: 45
• Duration (Months): 22

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Transplantation Infection	Procedure: Living donor liver transplantation

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 Design

• Study Type: Observational
• Actual Enrollment: 45 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Resistant Bacterial Infections in the Early Post LDLT Period
• Study Start Date: Jan 1, 2014
• Actual Primary Completion Date: Nov 1, 2015
• Actual Study Completion Date: Nov 1, 2015

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Determine the types of early bacterial infections following LDLT, recurrent and resistant infections all were confirmed by cultures. [Within the first 90 days after the operation]

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

2. Assessment of risk factors for occurrence of recurrent bacterial infections [The first 3 months following LDLT]

   Independent risk factors for infections

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Ain Shams University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yasmine Mahmoud Aly Massoud, Lecturer of Tropical medicine, Ain Shams University
• ClinicalTrials.gov Identifier: NCT02777632
• Other Study ID Numbers: 2652010
• First Posted: May 19, 2016
• Last Update Posted: Feb 6, 2017
• Last Verified: Feb 1, 2017

• Additional relevant MeSH terms: Infections; Communicable Diseases; Bacterial Infections

Study Results

No Results Posted as of Feb 6, 2017