Empirical vs 2nd Line Antibiotic Therapy in Health-care Associated Infections in Cirrhosis

NCT01820026 | Unknown Phase 4 DMC

• 1 other identifier: Infection and Cirrhosis
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

Bacterial infections are a frequent complication in liver cirrhosis with a bad prognosis. However, the clinical outcome of cirrhotic patients with serious infections is significantly improved over the last 30 years due to early diagnosis and to the use of a more appropriate antibiotic therapy. As in the general population, empirical treatment should be initiated soon after diagnosis, after making the necessary sampling and should be based on the use of an antibiotic with low toxicity and broad spectrum antibacterial efficacy, taking into account the local epidemiology and prevalence of antibiotic resistance. The third generation cephalosporins are considered the gold standard in the treatment of most infections in cirrhotics due to their effectiveness against enterobacteriaceae and against non-enterococcal streptococci and due to their low toxicity. However, the recommendations for the antibiotic therapy are currently based on results of trials of '80s and '90s, when the proportion of resistant pathogens was lower. Similarly to nosocomial infections, the increasing rate of infections due to multidrug resistant (MDR) bacteria represents the rational for a different choice of empirical antibiotic therapy with a higher resistance barrier. This change in the epidemiology of community acquired infections is mainly due to the increased contacts with healthcare system of these patients and for the larger use of antibiotic prophylaxis. With this regard, it was recently proposed to introduce a third epidemiological class of infection "Health care-associated": Infections occurring in community in patients who have been in contact with the health system shortly before the infection. This epidemiological class of infection should be distinguished from "community-acquired" because they are more similar to"nosocomial" in terms of their sensitivity to antibiotics. Therefore for this class should be taken into consideration the use of a different empirical antibiotic therapy. The investigators aim was to evaluate prospectively the effectiveness of a broad spectrum antibiotic treatment in a cohort of cirrhotic patients with "healthcare-Associated"infections Cirrhotic patients with "Healthcare Associated" admitted to the gastroenterology department of the Policlinico Umberto I and in the Department of Hepatology of the Hospital of Marino will be consecutively enrolled. Randomized controlled trial with randomisation stratified by epidemiological class of infection.

Conditions

Cirrhosis

Keywords

healthcare infection cirrhosis antibiotic

Outcome Measures

Primary Outcomes (1)

• Efficacy of anti-multiresistant empirical antibiotic therapy in healthcare associated infections in cirrhosis

  1 year

Study Arms (2)

Imipenem & Vancomycin & Azithromycin

EXPERIMENTAL

Tienam combined with vancomycin (1g/12 h) for Spontaneous bacterial peritonitis, cholangitis, sepsis without evidence of a source of infections. Tienam combined with vancomycin (1g/12 h)and azythromycin (500 mg/24 h)for pneumonia

Drug: Imipenem; Drug: Vancomycin; Drug: azithromycin

Cefotaxime & Amoxicillin & Azithromycin

ACTIVE COMPARATOR

Cefotaxime IV(2g/12 h): for Spontaneous bacterial peritonitis, cholangitis, sepsis without evidence of specific site of infection Amoxicillin/clavulanic acid (2,2 g/8 h)or Ciprofloxacin (500 mg/12 h: urinary tract infections Amoxicillin/clavulanic acid (2,2 g/8 h)and azithromycin (500 mg/24 h): pneumonia Amoxicillin/clavulanic acid (2,2 g/8 h)for skin or soft tissue infection

Drug: azithromycin; Drug: Cefotaxime; Drug: Amoxicillin

Interventions

Imipenem DRUG

second line therapy

Also known as: Tienam

Imipenem & Vancomycin & Azithromycin

Vancomycin DRUG

Second line therapy

Also known as: Vancocyn

Imipenem & Vancomycin & Azithromycin

azithromycin DRUG

Second line therapy

Also known as: Zithromax

Cefotaxime & Amoxicillin & Azithromycin; Imipenem & Vancomycin & Azithromycin

Cefotaxime DRUG

Standard antibiotic therapy

Cefotaxime & Amoxicillin & Azithromycin

Amoxicillin DRUG

Standard therapy

Also known as: Augmentin

Cefotaxime & Amoxicillin & Azithromycin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• cirrhosis
• healthcare infection
• older than 18 years
• agreement to participate

You may not qualify if:

• HIV
• patients underwent to liver transplantation

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Manuela Merli

Rome, Rome, 00100, Italy

RECRUITING

Related Publications (1)

• Merli M, Lucidi C, Di Gregorio V, Lattanzi B, Giannelli V, Giusto M, Farcomeni A, Ceccarelli G, Falcone M, Riggio O, Venditti M. An empirical broad spectrum antibiotic therapy in health-care-associated infections improves survival in patients with cirrhosis: A randomized trial. Hepatology. 2016 May;63(5):1632-9. doi: 10.1002/hep.28332. Epub 2016 Jan 5.

  PMID: 26529126 DERIVED

MeSH Terms

Conditions

Fibrosis

Interventions

Imipenem; Cilastatin, Imipenem Drug Combination; Vancomycin; Azithromycin; Cefotaxime; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thienamycins; Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cilastatin; Cyclopropanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Drug Combinations; Pharmaceutical Preparations; Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Erythromycin; Macrolides; Polyketides; Lactones; Cephacetrile; Cephalosporins; Thiazines; Sulfur Compounds; Ampicillin; Penicillin G; Penicillins; Clavulanic Acid; Clavulanic Acids

Study Officials

• Manuela Merli, Prof

  Gastroenterology

  PRINCIPAL INVESTIGATOR

• Claudio Puoti, Prof

  Department of Medicine Epatologica Marino Hospital

  STUDY CHAIR

Central Study Contacts

Manuela Merli, Prof

CONTACT

00390649972001; clucidi@hotmail.it

Cristina Lucidi, Dr

CONTACT

00393395263376; clucidi@hotmail.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: October 16, 2012
• First Posted: March 28, 2013
• Study Start: December 1, 2012
• Primary Completion: May 1, 2015
• Study Completion: June 1, 2015
• Last Updated: May 29, 2015

Record last verified: 2015-05

Locations

IT (1)