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

November 2, 2017 updated by: Institute of Liver and Biliary Sciences, India

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

146

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Delhi
      • New Delhi, Delhi, India, 110070
        • Institute of liver and Biliary Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Carbepenem+albumin+GMCSF.
Drug: Carbepenem
Drug: Albumin
Drug: GMCSF (of Granulocyte-Monocyte Colony-Stimulating Factor) .
Active Comparator: Carbepenem+albumin
Drug: Carbepenem
Drug: Albumin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total no of patients cured from SBP (Spontaneous Bacterial Peritonitis)
Time Frame: 1 week
1 week

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Liver and Biliary Sciences, India

Investigators

  • Principal Investigator: Vikash Prakash, MD, Institute of liver and Biliary Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2015

Primary Completion (Actual)

August 31, 2017

Study Completion (Actual)

August 31, 2017

Study Registration Dates

First Submitted

May 22, 2015

First Submitted That Met QC Criteria

June 5, 2015

First Posted (Estimate)

June 10, 2015

Study Record Updates

Last Update Posted (Actual)

November 6, 2017

Last Update Submitted That Met QC Criteria

November 2, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ILBS-SBP-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Spontaneous Bacterial Peritonitis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Oman

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe