Antibiotic-resistant Bacterial Infection of Hepatic Patients

February 25, 2019 updated by: Karema Azoz Mostafa, Assiut University

Patterns of Antibiotic Resistant Bacterial Infections in Liver Intensive Care Unit

the investigators want to identify the microbial profile, antibiotic resistant bacteria in hepatic patients with infections in Liver ICU, and explore risk factors and outcomes in those patients with antibiotic resistant bacteria.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Bacterial infection signifies major clinical challenge in cirrhotic patients where about 35% of these patients acquire hospital-acquired infections compared with 5% of other hospital in-patients without cirrhosis.It is associated with a mortality rate of 38% with a four-fold increase compared to individuals without cirrhosis.

Cirrhotic patients have a high risk for antimicrobial resistance because of chronic use of prescribed antibiotics like quinolones in secondary prophylaxis for spontaneous bacterial peritonitis. In addition, undergoing invasive procedures and recurrent hospital admissions encourage both increased occurrence of antimicrobial resistance and the spread of resistant pathogens in these patients.

Epidemiology, risk factors and clinical outcomes of MDR infections have raised a special attention in cirrhosis. Some studies reported bacterial resistance in about 50% of examined patients and it is associated with treatment failure, septic shock and hospital mortality especially in nosocomial and healthcare related infections

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients diagnosed to have ESLD admitted to EL-Rajhi liver hsopital (Assiut university hopsitals) diagnosed to have infection at admission or develop infection during hospitalization

Description

Inclusion Criteria:

  • Patients with ESLD at Liver ICU. All patients have the diagnostic criteria for liver cirrhosis by clinical, biochemical, and ultrasonography findings. The severity of liver cirrhosis will be assessed according to the Child-Pugh classification and model for end-stage liver disease (MELD) score.
  • These patients are diagnosed as having infection at admission or acquire infection during hospitalization.

Exclusion Criteria:

  • Age ≤ 18 years

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of different bacterial causing infections in hepatic patients
Time Frame: baseline
Bacteriological cultures will be performed with VITEK 2 COMPACT-15 automated system (bioMerieux Inc, Mercy L'etoil, Fransa).
baseline
To detect antibiotic resistant bacteria among these patients.
Time Frame: baseline
molecular detection of genes responsible for antibiotic resistance using PCR for isolates bacteria
baseline

Collaborators and Investigators

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

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

May 1, 2019

Primary Completion (Anticipated)

May 1, 2020

Study Completion (Anticipated)

July 1, 2020

Study Registration Dates

First Submitted

February 25, 2019

First Submitted That Met QC Criteria

February 25, 2019

First Posted (Actual)

February 27, 2019

Study Record Updates

Last Update Posted (Actual)

February 27, 2019

Last Update Submitted That Met QC Criteria

February 25, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • bacterial resistence

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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