Daptomycin + Meropenem Versus Ceftazidime in the Treatment of Nosocomial Spontaneous Bacterial Peritonitis

Last updated: October 11, 2014
Sponsor: University of Padova
Overall Status: Terminated

Phase

2/3

Condition

Liver Disorders

Liver Disease

Intra-abdominal Infections

Treatment

N/A

Clinical Study ID

NCT01455246
2059P
2010-019625-34
  • Ages 18-75
  • All Genders

Study Summary

Nosocomial spontaneous bacterial peritonitis (SBP) is frequently caused by multi drug resistant bacteria. Standard treatment of SBP could be ineffective. The aim of the study is to compare daptomycin + meropenem vs ceftazidime in the treatment of nosocomial SBP.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with liver cirrhosis and ascites

  • Meets all criteria for nosocomial SBP as outlined below

  • Ascitic fluid polymorphonuclear cells count >250/mm3

  • Onset of signs and symptoms of infection after 72 hours of hospitalization

Exclusion

Exclusion Criteria:

  • Hepatocellular carcinoma beyond the Milan criteria

  • Abdominal surgery within 4 weeks

  • Evidence of secondary peritonitis, pancreatitis or peritoneal carcinomatosis

  • Significant heart or respiratory failure

  • Allergy to ceftazidime, meropenem or daptomycin

Study Design

Total Participants: 32
Study Start date:
October 01, 2010
Estimated Completion Date:
July 31, 2014

Study Description

Spontaneous bacterial peritonitis (SBP) is a well known complication in patients with liver cirrhosis and ascites. Nosocomial SBP is defined as SBP that occurs after 48 hours of hospitalization. It has been shown that patients with nosocomial SBP have a worse prognosis than patients with community-acquired SBP. It has also been shown that nosocomial SBP is frequently caused by multi drug resistant bacteria such as extended-spectrum-beta-lactamase (ESBL) producing enterobacteria or meticillin - resistant staphylococcus aureus. Currently the empirical treatment of SBP is the use of third generation cephalosporins or amoxicillin/clavulanic acid. In patients affected by nosocomial SBP these treatment could be ineffective. Up to now an empirical approach with a broader spectrum strategy (such as an association between meropenem and daptomycin) has never been compared to standard therapy in the treatment of nosocomial SBP. Thus, the aim of the study is to compare daptomycin + meropenem vs ceftazidime in the treatment of nosocomial SBP in patients with cirrhosis.

Connect with a study center

  • Dept. of Clinical and Experimental Medicine, University of Padova

    Padova, PD 35128
    Italy

    Site Not Available

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