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

University of Padova

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Nosocomial Spontaneous Bacterial Peritonitis; Cirrhosis; Ascites

Treatments: Drug: Daptomycin + Meropenem; Drug: Ceftazidime

Study type: Interventional

Funder types: Other

Identifiers

NCT01455246

2010-019625-34 (EudraCT Number)

2059P

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Daptomycin + Meropenem

Experimental group

Description:

30 patients with cirrhosis and nosocomial SBP

Treatment:

Drug: Daptomycin + Meropenem

Ceftazidime

Active Comparator group

Description:

30 patients with cirrhosis and nosocomial SBP

Treatment:

Drug: Ceftazidime