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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

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.

Condition or disease Intervention/treatment
Antibiotic Resistant Infection Liver Cirrhoses Diagnostic Test: microbiological culture and sensetivity

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

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Patterns of Antibiotic Resistant Bacterial Infections in Liver Intensive Care Unit
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

Intervention Details:
  • 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

Primary Outcome Measures :
  1. 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).

  2. To detect antibiotic resistant bacteria among these patients. [ Time Frame: baseline ]
    molecular detection of genes responsible for antibiotic resistance using PCR for isolates bacteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03855709

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Contact: Karema Azoz Mostafa +201018494961

Sponsors and Collaborators
Assiut University


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Responsible Party: Karema Azoz Mostafa, Specialist, Assiut University Identifier: NCT03855709    
Other Study ID Numbers: bacterial resistence
First Posted: February 27, 2019    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Communicable Diseases
Bacterial Infections
Liver Cirrhosis
Liver Diseases
Digestive System Diseases
Anti-Bacterial Agents
Anti-Infective Agents