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

Phase 2

Terminated

• Conditions: Cirrhosis; Nosocomial Spontaneous Bacterial Peritonitis; Ascites
• Interventions: Drug: Daptomycin + Meropenem; Drug: Ceftazidime

• Registration Number: NCT01455246
• Lead Sponsor: University of Padova

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2011-10-13
• Study First Submitted QC: 2011-10-17
• Study First Posted: 2011-10-19
• Primary Completion: 2014-04
• Study Completion: 2014-07
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-11
• Last Update Posted: 2014-10-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 32

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 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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Daptomycin + Meropenem	Daptomycin + Meropenem	30 patients with cirrhosis and nosocomial SBP
Ceftazidime	Ceftazidime	30 patients with cirrhosis and nosocomial SBP

Primary Outcome Measures

Name	Time	Method
The primary end-point of the study is the response to therapy	48 hours and seven days	The response to therapy is defined as the reduction of polymorphonuclear leukocytes (PMN) count in ascitic fluid more than 25 % from baseline after 48 hours and as a PMN count in ascitic fluid less then 250/mm³ after seven days.

Secondary Outcome Measures

Name	Time	Method
Mortality during hospitalization	participants will be followed for the duration of hospital stay, an expected average of 6 weeks
30 days mortality	30 days
90 days mortality	90 days

Trial Locations

Locations (1)

Dept. of Clinical and Experimental Medicine, University of Padova; 🇮🇹 Padova, PD, Italy