Antibiotic-resistant Bacterial Infection of Hepatic Patients

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ClinicalTrials.gov Identifier: NCT03855709

Recruitment Status : Unknown

Verified February 2019 by Karema Azoz Mostafa, Assiut University.
Recruitment status was: Not yet recruiting

First Posted : February 27, 2019

Last Update Posted : February 27, 2019

Sponsor:

Information provided by (Responsible Party):

Karema Azoz Mostafa, Assiut University

Study Description

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

Study Design

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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

MedlinePlus Genetics related topics: North American Indian childhood cirrhosis

MedlinePlus related topics: Antibiotics Bacterial Infections

U.S. FDA Resources

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

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

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

Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT03855709

Contacts

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Contact: Karema Azoz Mostafa	+201018494961	karimaazoz89@gmail.com

Sponsors and Collaborators

Assiut University

More Information

Publications:

Fernández J, Acevedo J, Castro M, Garcia O, de Lope CR, Roca D, Pavesi M, Sola E, Moreira L, Silva A, Seva-Pereira T, Corradi F, Mensa J, Ginès P, Arroyo V. Prevalence and risk factors of infections by multiresistant bacteria in cirrhosis: a prospective study. Hepatology. 2012 May;55(5):1551-61. doi: 10.1002/hep.25532. Epub 2012 Apr 4.

Fernández J, Navasa M, Gómez J, Colmenero J, Vila J, Arroyo V, Rodés J. Bacterial infections in cirrhosis: epidemiological changes with invasive procedures and norfloxacin prophylaxis. Hepatology. 2002 Jan;35(1):140-8.

Arvaniti V, D'Amico G, Fede G, Manousou P, Tsochatzis E, Pleguezuelo M, Burroughs AK. Infections in patients with cirrhosis increase mortality four-fold and should be used in determining prognosis. Gastroenterology. 2010 Oct;139(4):1246-56, 1256.e1-5. doi: 10.1053/j.gastro.2010.06.019. Epub 2010 Jun 14.

Merli M, Lucidi C, Di Gregorio V, Falcone M, Giannelli V, Lattanzi B, Giusto M, Ceccarelli G, Farcomeni A, Riggio O, Venditti M. The spread of multi drug resistant infections is leading to an increase in the empirical antibiotic treatment failure in cirrhosis: a prospective survey. PLoS One. 2015 May 21;10(5):e0127448. doi: 10.1371/journal.pone.0127448. eCollection 2015.

Merli M, Lucidi C. Bacterial resistance in cirrhotic patients: an emerging reality. J Hepatol. 2012 Apr;56(4):756-7. doi: 10.1016/j.jhep.2011.12.004. Epub 2012 Jan 8.

Shallcross L, O'Brien A. Antimicrobial resistance in liver disease: better diagnostics are needed. Lancet Gastroenterol Hepatol. 2017 Mar;2(3):151-153. doi: 10.1016/S2468-1253(16)30240-0. Epub 2017 Feb 9.

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Responsible Party:	Karema Azoz Mostafa, Specialist, Assiut University
ClinicalTrials.gov 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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Infections Communicable Diseases Bacterial Infections Liver Cirrhosis Disease Attributes	Pathologic Processes Fibrosis Liver Diseases Digestive System Diseases Bacterial Infections and Mycoses

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