Resistant Bacterial Infections in the Early Post LDLT Period

Transplantation Infection Clinical Trial

Official title:

Resistant Bacterial Infections in the Early Post LDLT Period

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02777632
• Other study ID #: 2652010
• Status: Completed
• Phase: N/A
• First received: May 17, 2016
• Last updated: February 2, 2017
• Start date: January 2014
• Est. completion date: November 2015

Study information

• Verified date: February 2017
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Infections
• Communicable Diseases
• Infection
• Transplantation Infection

Intervention

Procedure:
• Living donor liver transplantation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Assessment of risk factors for occurrence of recurrent bacterial infections	Independent risk factors for infections	The first 3 months following LDLT