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

A Randomized, Comparative Open Label Study of Imipenem Versus Cefepime in Spontaneous Bacterial Peritonitis and to Evaluate the Risk Factors for Treatment Failure.

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).

Study Overview

• Status: Completed
• Conditions: Spontaneous Bacterial Peritonitis
• Intervention / Treatment: Drug: Imipenem + Albumin; Drug: cefepime + Albumin

Detailed Description

Baseline evaluation:

Baseline clinical, laboratory and disease severity parameters will be evaluated for each study patient.

1. Etiology of cirrhosis.
2. Severity of liver disease. CTP (Child-Turcotte-Pugh) score MELD (Model for End-stage Liver Disease) score MELD (Model for End-stage Liver Disease)-Na score IMSAA score
3. Decompensations/complications of CLD (Chronic Liver Disease) UGI bleed, Hepatic encephalopathy, AKI (Acute Kidney Injury) etc.
4. Laboratory investigations:

Serum electrolytes Liver function tests Kidney function tests Pro calcitonin USG/CT abdomen Complete blood counts Coagulation parameters Ascitic fluid analysis- TLC, DLC, Protein, sugar, culture, SAAG. Chest X ray PA view HBsAg and Anti-HCV and other etiological workup as available.

• Study Type: Interventional
• Enrollment (Actual): 175
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110070
      • Institute of Liver & Biliary Sciences (ILBS)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cefepime + Albumin; cefepime 1g iv 8 hourly + Albumin will be given for 2 days.	Drug: Imipenem + Albumin; Imipenem + Albumin will be given for 2 days.
Active Comparator: Imipenem + Albumin; Imipenem 1g iv 8 hourly + Albumin will be given for 2 days.	Drug: cefepime + Albumin; cefepime + Albumin will be given for 2 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary outcome of the study is the Response to treatment in each intervention group. Response is defined as 25% reduction in ANC (Absolute Neutrophil Count) from baseline.	2 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Survival	15 days,1 month and 3 months

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India
• Investigators: Principal Investigator: Dr Ankur Jindal, MD, Institute of Liver & Biliary Sciences (ILBS)

Publications and helpful links

General Publications

• Jindal A, Kumar M, Bhadoria AS, Maiwall R, Sarin SK. A randomized open label study of 'imipenem vs. cefepime' in spontaneous bacterial peritonitis. Liver Int. 2016 May;36(5):677-87. doi: 10.1111/liv.12985. Epub 2015 Nov 21.

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: December 6, 2012
• First Submitted That Met QC Criteria: May 9, 2013
• First Posted (Estimate): May 14, 2013

Study Record Updates

• Last Update Posted (Estimate): November 22, 2016
• Last Update Submitted That Met QC Criteria: November 21, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Peritoneal Diseases; Intraabdominal Infections; Peritonitis; Anti-Infective Agents; Anti-Bacterial Agents; Imipenem; Cefepime
• Other Study ID Numbers: ILBS- SBP-01