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

Primary Purpose

Spontaneous Bacterial Peritonitis

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
cefepime + Albumin
Imipenem + Albumin
Sponsored by
Institute of Liver and Biliary Sciences, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spontaneous Bacterial Peritonitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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 -

  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.

Sites / Locations

  • Institute of Liver & Biliary Sciences (ILBS)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

cefepime + Albumin

Imipenem + Albumin

Arm Description

cefepime 1g iv 8 hourly + Albumin will be given for 2 days.

Imipenem 1g iv 8 hourly + Albumin will be given for 2 days.

Outcomes

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.

Secondary Outcome Measures

Survival

Full Information

First Posted
December 6, 2012
Last Updated
November 21, 2016
Sponsor
Institute of Liver and Biliary Sciences, India
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1. Study Identification

Unique Protocol Identification Number
NCT01852630
Brief Title
Imipenem Versus Cefepime in Spontaneous Bacterial Peritonitis and to Evaluate the Risk Factors for Treatment Failure
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 Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Liver and Biliary Sciences, India

4. Oversight

Data Monitoring Committee
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spontaneous Bacterial Peritonitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
175 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cefepime + Albumin
Arm Type
Experimental
Arm Description
cefepime 1g iv 8 hourly + Albumin will be given for 2 days.
Arm Title
Imipenem + Albumin
Arm Type
Active Comparator
Arm Description
Imipenem 1g iv 8 hourly + Albumin will be given for 2 days.
Intervention Type
Drug
Intervention Name(s)
cefepime + Albumin
Intervention Description
cefepime + Albumin will be given for 2 days
Intervention Type
Drug
Intervention Name(s)
Imipenem + Albumin
Intervention Description
Imipenem + Albumin will be given for 2 days.
Primary Outcome Measure Information:
Title
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.
Time Frame
2 days
Secondary Outcome Measure Information:
Title
Survival
Time Frame
15 days,1 month and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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 - 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Ankur Jindal, MD
Organizational Affiliation
Institute of Liver & Biliary Sciences (ILBS)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Liver & Biliary Sciences (ILBS)
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
26474358
Citation
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.
Results Reference
derived

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

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