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Antibiotic-resistant Bacterial Infection of Hepatic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03855709
Recruitment Status : Not yet recruiting
First Posted : February 27, 2019
Last Update Posted : February 27, 2019
Information provided by (Responsible Party):
Karema Azoz Mostafa, Assiut University

Tracking Information
First Submitted Date February 25, 2019
First Posted Date February 27, 2019
Last Update Posted Date February 27, 2019
Estimated Study Start Date May 2019
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 25, 2019)
  • 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).
  • To detect antibiotic resistant bacteria among these patients. [ Time Frame: baseline ]
    molecular detection of genes responsible for antibiotic resistance using PCR for isolates bacteria
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title Antibiotic-resistant Bacterial Infection of Hepatic Patients
Official Title Patterns of Antibiotic Resistant Bacterial Infections in Liver Intensive Care Unit
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
  • Antibiotic Resistant Infection
  • Liver Cirrhoses
Intervention Diagnostic Test: microbiological culture and sensetivity
microbioloical culture will be used to detect microbiological profile in hepatic patients with infections, drug sensitivity to detect resistent bacteria which will be confirmed using PCR detection of resistent gene
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: February 25, 2019)
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2020
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contact: Karema Azoz Mostafa +201018494961
Listed Location Countries Not Provided
Removed Location Countries  
Administrative Information
NCT Number NCT03855709
Other Study ID Numbers bacterial resistence
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Karema Azoz Mostafa, Assiut University
Study Sponsor Assiut University
Collaborators Not Provided
Investigators Not Provided
PRS Account Assiut University
Verification Date February 2019