Antibiotic-resistant Bacterial Infection of Hepatic Patients

Antibiotic Resistant Infection Clinical Trial

Official title:

Patterns of Antibiotic Resistant Bacterial Infections in Liver Intensive Care Unit

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03855709
• Other study ID #: bacterial resistence
• Status: Not yet recruiting
• Start date: May 2019
• Est. completion date: July 2020

Study information

• Verified date: February 2019
• Source: Assiut University
• Contact: Karema Azoz Mostafa
• Phone: +201018494961
• Email: karimaazoz89[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: July 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Antibiotic Resistant Infection
• Bacterial Infections
• Communicable Diseases
• Infection
• Liver Cirrhoses
• Liver Cirrhosis

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View 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. — View 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. — View 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. — View Citation

Outcome

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