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

Sponsor

Institute of Liver and Biliary Sciences, India (Other)

Overall Status

Completed

CT.gov ID

NCT01852630

Collaborator

(none)

175

Enrollment

Location

Arms

Duration (Months)

4.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Spontaneous Bacterial Peritonitis	Drug: cefepime + Albumin Drug: Imipenem + Albumin	N/A

Detailed Description

Baseline evaluation:

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

Etiology of cirrhosis.
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
Decompensations/complications of CLD (Chronic Liver Disease) UGI bleed, Hepatic encephalopathy, AKI (Acute Kidney Injury) etc.
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 Design

Study Type:

Interventional

Actual Enrollment :

175 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2012

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Dec 1, 2015

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Survival [15 days,1 month and 3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 -

Nosocomial SBP: occurence of SBP (Spontaneous Bacterial Peritonitis) after 48 hours of hospital admission, or
Prior ascitic fluid infection with 3rd generation cephalosporin resistant organism, or
No response to treatment with 3rd generation cephalosporins after 48 hours.

Exclusion Criteria:

Age less than 18 years.
Cirrhotics with SBP (Spontaneous Bacterial Peritonitis) managed as outpatients.
Post liver transplant, HIV patients.
Patients on systemic chemotherapy, immunosuppressant drugs.
Growth of bacteria resistant to intervention drugs in ascitic fluid culture.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of Liver & Biliary Sciences (ILBS)	New Delhi	Delhi	India	110070

Sponsors and Collaborators

Institute of Liver and Biliary Sciences, India

Investigators

Principal Investigator: Dr Ankur Jindal, MD, Institute of Liver & Biliary Sciences (ILBS)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Institute of Liver and Biliary Sciences, India

ClinicalTrials.gov Identifier:

NCT01852630

Other Study ID Numbers:

ILBS- SBP-01

First Posted:

May 14, 2013

Last Update Posted:

Nov 22, 2016

Last Verified:

Jul 1, 2016

Additional relevant MeSH terms:

Peritonitis

Imipenem

Cefepime

Study Results

No Results Posted as of Nov 22, 2016