NCT Number: NCT02777632
Resistant Bacterial Infections in the Early Post LDLT Period
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
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Conditions
Age range
18 year–60 year
Sex eligibility
All sexes
Study type
Observational
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
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.
-
Assessment of risk factors for occurrence of recurrent bacterial infections
Time frame: The first 3 months following LDLT
Independent risk factors for infections
Sponsors and collaborators
Lead sponsor
Ain Shams University
Other
Registry information
Important dates
- Study start
- 2014
- Primary completion
- 2015
- Study completion
- 2015
- First posted
- May 19, 2016
- Registry last updated
- Feb 6, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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