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A randomized open label study of ‘imipenem vs. cefepime’ in spontaneous bacterial peritonitis
Author(s) -
Jindal Ankur,
Kumar Manoj,
Bhadoria Ajeet S.,
Maiwall Rakhi,
Sarin Shiv K.
Publication year - 2016
Publication title -
liver international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.873
H-Index - 110
eISSN - 1478-3231
pISSN - 1478-3223
DOI - 10.1111/liv.12985
Subject(s) - medicine , spontaneous bacterial peritonitis , cefepime , septic shock , imipenem , hazard ratio , gastroenterology , randomized controlled trial , peritonitis , sepsis , antibiotics , antibiotic resistance , confidence interval , ascites , microbiology and biotechnology , biology
Background & Aims Spontaneous bacterial peritonitis ( SBP ), in the presence of bacterial resistance or failure of third generation cephalosporins (3rd GC ) has poor outcome. Empirical antibiotic(s) options are limited in these scenarios. Methods Consecutive cirrhotics with SBP because of hospital acquired SBP (>48 h of admission), microbial resistance or non‐response (no resolution of SBP at 48 h) were randomized to Cefepime ( n = 88) or Imipenem ( n = 87) plus standard medical therapy. We assessed for ‘response at 48 h’ (reduction in ascitic fluid absolute neutrophil count ( ANC ) by >25% at 48 h), resolution of SBP (<250 cu/mm ANC at day 5) and their clinical outcome. Results Of 957 paracentesis in 1200 hospitalized cirrhotics, 253 (26.4%) had SBP and 175 (69.6%) were randomized. Baseline parameters were comparable in two groups. Response at 48 h (58.6% vs. 51.7%; P = 0.4) and resolution of SBP in those with response at 48 h were comparable with no difference in mortality at week 2, month 1 and 3. Patients with ‘No response at 48 h’ had higher mortality compared with responders (73.8% vs. 25%; P < 0.001). Resolution of SBP was associated with ‘response at 48 h’ and septic shock, latter being main pre‐terminal event. AKI at enrolment [Hazard ratio ( HR ), 2.6], pneumonia [ HR , 2.9], septic shock [ HR , 2.2] and response at 48 h [ HR , 4.6] predicted poor outcome. Conclusions In hospitalized cirrhotics with SBP and risk factors for treatment failure, cefepime showed comparable efficacy and survival to imipenem. Non‐response to therapy at 48 h is a reliable predictor of treatment failure and mortality. Antibiotic combinations and novel options are needed for these patients.