TerminatedPhase 2/3

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

Stopped: Decision of independent monitoring committee after interim analysis: Risk of failure significantly higher in ceftazidime group.

Italy32 participantsStarted 2010-10

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

The primary end-point of the study is the response to therapy

Timeframe: 48 hours and seven days

Trial details

NCT IDNCT01455246

SponsorUniversity of Padova

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-04

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