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Status unknownNCT03855709Updated Feb 27, 2019

Antibiotic-resistant Bacterial Infection of Hepatic Patients

An observational study in Antibiotic Resistant Infection and Liver Cirrhoses, sponsored by Assiut University. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-27.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Feb 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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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Conditions studied

  • Antibiotic Resistant Infection
  • Liver Cirrhoses
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In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's planned enrollment of 200 is below the median of 240 across 2,136 observational studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  • Age ≤ 18 years
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testmicrobiological 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

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What researchers measure

Primary outcomes

  1. 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).

    Time frame: baseline

  2. To detect antibiotic resistant bacteria among these patients.

    molecular detection of genes responsible for antibiotic resistance using PCR for isolates bacteria

    Time frame: baseline

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 22183941 ↗
  • 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. PubMed 11786970 ↗
  • 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. PubMed 20558165 ↗
  • 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. PubMed 25996499 ↗
  • 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. PubMed 22230869 ↗
  • 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. PubMed 28404125 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03855709
Lead sponsor
Assiut University
Responsible party
Karema Azoz Mostafa (Specialist, Assiut University) — Principal investigator
First posted
Feb 27, 2019
Start date
May 2019 (estimated)
Primary completion
May 2020 (estimated)
Completion
Jul 2020 (estimated)
Last update
Feb 27, 2019

Study contacts

Karema Azoz Mostafa
Contact
karimaazoz89@gmail.com
+201018494961
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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