Imipenem Versus Cefepime in Spontaneous Bacterial Peritonitis and to Evaluate the Risk Factors for Treatment Failure

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

1. All consecutive patients with Cirrhosis and ascites admitted to ILBS (Institute of Liver & Biliary Sciences) will be evaluated for the presence of SBP (Spontaneous Bacterial Peritonitis) by ascitic fluid examination at admission.

2. SBP (Spontaneous Bacterial Peritonitis) will be diagnosed in the presence of absolute neutrophil count (ANC >250/mm3) with/without positive ascitic fluid culture and Patients with SBP (Spontaneous Bacterial Peritonitis) included in the study will be randomized to receive cefepime or imipenem.

3. However, other SBP (Spontaneous Bacterial Peritonitis) patients not included for randomization will be given empirical therapy with 3rd generation cephalosporin (ceftriaxone).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Liver and Biliary Sciences, India
• Treatments: Cefepime; Cephalosporins; Imipenem

Criteria

Inclusion Criteria:

• Cirrhotic Patients with SBP (Spontaneous Bacterial Peritonitis) having any of the following risk factors would be considered as 'Difficult to Treat SBP' and would be included -

1. Nosocomial SBP: occurence of SBP (Spontaneous Bacterial Peritonitis) after 48 hours of hospital admission, or

2. Prior ascitic fluid infection with 3rd generation cephalosporin resistant organism, or

3. No response to treatment with 3rd generation cephalosporins after 48 hours.

Exclusion Criteria:

1. Age less than 18 years.

2. Cirrhotics with SBP (Spontaneous Bacterial Peritonitis) managed as outpatients.

3. Post liver transplant, HIV patients.

4. Patients on systemic chemotherapy, immunosuppressant drugs.

5. Growth of bacteria resistant to intervention drugs in ascitic fluid culture.