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To Compare the Efficacy of Carbepenem Versus Carbepenem Plus GM-CSF in Difficult To Treat Spontaneous Bacterial Peritonitis

Primary Purpose

Spontaneous Bacterial Peritonitis

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Carbepenem
Albumin
GMCSF (of Granulocyte-Monocyte Colony-Stimulating Factor) .
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 - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age more than 18 years

  2. Patients of decompensated liver cirrhosis who present with- Spontaneous bacterial peritonitis (Presence of more than 250 neutrophils per cc of ascetic fluid, in the absence of a surgical abdomen, in the presence of decompensated cirrhosis and portal hypertension) that is not responding to initial therapy- DTT-SBP:

    • Hospital acquired - New onset SBP (Spontaneous bacterial peritonitis) after 48 h of hospitalization.
    • Recurrent SBP - One or more prior episode(s) of SBP in year.
    • Antibiotic resistant - Resistance to 3rd Gen Cephalosporin in last 3 m.
    • Antibiotic non-response -Non-response to 3rd Gen Cephalosporin, sepsis on 3rd Gen Cephalosporin.

Exclusion Criteria:

  1. < 18 years.
  2. Advanced HCC (HepatoCellular Carcinoma)
  3. Post liver transplant
  4. HIV + ve, Immunosuppressive therapy
  5. Pregnancy
  6. Domiciliary treatment
  7. No consent

Sites / Locations

  • Institute of Liver and Biliary Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Carbepenem+albumin+GMCSF.

Carbepenem+albumin

Arm Description

Outcomes

Primary Outcome Measures

Total no of patients cured from SBP (Spontaneous Bacterial Peritonitis)

Secondary Outcome Measures

Survival at week 2
Survival at week 4
Survival at week 12
Total number of patients develop variceal bleed.
Total number of patients develop non-SBP (Spontaneous Bacterial Peritonitis) infections within 1 wk of enrolment.
Total number of patients develop HE (Hepatic Encephalopathy).
Total number of patients develop AKI (Acute kidney Injury).

Full Information

First Posted
May 22, 2015
Last Updated
November 2, 2017
Sponsor
Institute of Liver and Biliary Sciences, India
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1. Study Identification

Unique Protocol Identification Number
NCT02468089
Brief Title
To Compare the Efficacy of Carbepenem Versus Carbepenem Plus GM-CSF in Difficult To Treat Spontaneous Bacterial Peritonitis
Official Title
A Randomized Study to Compare the Efficacy of Carbepenem Versus Carbepenem Plus GM-CSF in Difficult To Treat Spontaneous Bacterial Peritonitis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
May 1, 2015 (Actual)
Primary Completion Date
August 31, 2017 (Actual)
Study Completion Date
August 31, 2017 (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
A Minimum of 150 consecutive patients of decompensated cirrhosis of any etiology, presenting to the Institute of Liver and Biliary Sciences hospital with a diagnosis of difficult to treat SBP will be included and randomized into two treatment groups. Group A - Carbepenem+albumin Group B - Carbepenem+albumin+GMCSF.

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
146 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Carbepenem+albumin+GMCSF.
Arm Type
Experimental
Arm Title
Carbepenem+albumin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Carbepenem
Intervention Type
Drug
Intervention Name(s)
Albumin
Intervention Type
Drug
Intervention Name(s)
GMCSF (of Granulocyte-Monocyte Colony-Stimulating Factor) .
Primary Outcome Measure Information:
Title
Total no of patients cured from SBP (Spontaneous Bacterial Peritonitis)
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Survival at week 2
Time Frame
week 2
Title
Survival at week 4
Time Frame
week 4
Title
Survival at week 12
Time Frame
week 12
Title
Total number of patients develop variceal bleed.
Time Frame
1 week
Title
Total number of patients develop non-SBP (Spontaneous Bacterial Peritonitis) infections within 1 wk of enrolment.
Time Frame
1 week
Title
Total number of patients develop HE (Hepatic Encephalopathy).
Time Frame
1 week
Title
Total number of patients develop AKI (Acute kidney Injury).
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age more than 18 years Patients of decompensated liver cirrhosis who present with- Spontaneous bacterial peritonitis (Presence of more than 250 neutrophils per cc of ascetic fluid, in the absence of a surgical abdomen, in the presence of decompensated cirrhosis and portal hypertension) that is not responding to initial therapy- DTT-SBP: Hospital acquired - New onset SBP (Spontaneous bacterial peritonitis) after 48 h of hospitalization. Recurrent SBP - One or more prior episode(s) of SBP in year. Antibiotic resistant - Resistance to 3rd Gen Cephalosporin in last 3 m. Antibiotic non-response -Non-response to 3rd Gen Cephalosporin, sepsis on 3rd Gen Cephalosporin. Exclusion Criteria: < 18 years. Advanced HCC (HepatoCellular Carcinoma) Post liver transplant HIV + ve, Immunosuppressive therapy Pregnancy Domiciliary treatment No consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vikash Prakash, MD
Organizational Affiliation
Institute of Liver and Biliary Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Liver and Biliary Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India

12. IPD Sharing Statement

Learn more about this trial

To Compare the Efficacy of Carbepenem Versus Carbepenem Plus GM-CSF in Difficult To Treat Spontaneous Bacterial Peritonitis

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