Antibiotic-resistant Bacterial Infection of Hepatic Patients

• Conditions: Antibiotic Resistant Infection; Liver Cirrhoses

• Registration Number: NCT03855709
• Lead Sponsor: Assiut University

Brief Summary

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.

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 Timeline

• Status Verified: 2019-02
• Study First Submitted: 2019-02-25
• Study First Submitted QC: 2019-02-25
• Last Update Submitted: 2019-02-25
• Study First Posted: 2019-02-27
• Last Update Posted: 2019-02-27
• Study Start: 2019-05
• Primary Completion: 2020-05
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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