Clinical trial NCT03855709: Antibiotic-resistant Bacterial Infection of Hepatic Patients
Official title: Patterns of Antibiotic Resistant Bacterial Infections in Liver Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Antibiotic Resistant Infection
Liver Cirrhoses
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-02-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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

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

Primary outcomes:
measure: Detection of different bacterial causing infections in hepatic patients
timeFrame: baseline
measure: To detect antibiotic resistant bacteria among these patients.
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Fernandez 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, Gines 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.
citation: Fernandez J, Navasa M, Gomez J, Colmenero J, Vila J, Arroyo V, Rodes J. Bacterial infections in cirrhosis: epidemiological changes with invasive procedures and norfloxacin prophylaxis. Hepatology. 2002 Jan;35(1):140-8. doi: 10.1053/jhep.2002.30082.
citation: 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.
citation: 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.
citation: 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. No abstract available.
citation: 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. No abstract available.