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

NCT ID: NCT02468089

Last Updated: 2017-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-01

Study Completion Date

2017-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Spontaneous Bacterial Peritonitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Carbepenem+albumin+GMCSF.

Group Type EXPERIMENTAL

Carbepenem

Intervention Type DRUG

Albumin

Intervention Type DRUG

GMCSF (of Granulocyte-Monocyte Colony-Stimulating Factor) .

Intervention Type DRUG

Carbepenem+albumin

Group Type ACTIVE_COMPARATOR

Carbepenem

Intervention Type DRUG

Albumin

Intervention Type DRUG

Interventions

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Carbepenem

Intervention Type DRUG

Albumin

Intervention Type DRUG

GMCSF (of Granulocyte-Monocyte Colony-Stimulating Factor) .

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Liver and Biliary Sciences, India

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vikash Prakash, MD

Role: PRINCIPAL_INVESTIGATOR

Institute of Liver and Biliary Sciences

Locations

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Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, India

Site Status

Countries

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India

Other Identifiers

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ILBS-SBP-001

Identifier Type: -

Identifier Source: org_study_id