Comparison of the Efficacy of Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) and Norfloxacin in Secondary Prophylaxis for Spontaneous Bacterial Peritonitis

Institute of Liver and Biliary Sciences, India120 enrolled

Overview

-Consecutive patients of decompensated cirrhosis of any etiology, presenting to the Institute of Liver and Biliary Sciences hospital with spontaneous bacterial peritonitis will be evaluated

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

120

Conditions

Spontaneous Bacterial Peritonitis

Interventions

GMCSFDRUG

GMCSF 1.5mcg/Kg

NorfloxacinDRUG

Tablet Norfloxacin 400 mg

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18 - 70years * Patients of decompensated liver cirrhosis who present with spontaneous bacterial peritonitis (Presence of more than 250 neutrophils per cc of ascitic fluid, in the absence of a surgical abdomen, in the presence of decompensated cirrhosis and portal hypertension) that has responded to standard medical care. Exclusion Criteria: * Allergic to quinolones * Advanced HCC (Hepatocellular Carcinoma) * Post liver transplant * HIV (Human Immunodeficiency Virus) positive patients * Patients on immunosuppressive therapy * Pregnancy * Acute Liver Failure * History of hematological malignancy or bone marrow transplantation * No informed consent

Locations (1)

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, India

Outcomes

Primary Outcomes

Spontaneous Bacterial Peritonitis on secondary prophylaxis in both groups

Spontaneous Bacterial Peritonitis is defined as Polymorphonuclear count \> 250 in ascitic fluid

Time frame: 6 Month

Secondary Outcomes

Survival in both groups after development of SBP (Spontaneous Bacterial Peritonitis ).

Spontaneous Bacterial Peritonitis is defined as Polymorphonuclear count \> 250 in ascitic fluid.

Time frame: 4 weeks

Survival in both groups after development of SBP (Spontaneous Bacterial Peritonitis ).

Spontaneous Bacterial Peritonitis is defined as Polymorphonuclear count \> 250 in ascitic fluid.

Time frame: 12 weeks

Survival in both groups after development of SBP (Spontaneous Bacterial Peritonitis ).

Spontaneous Bacterial Peritonitis is defined as Polymorphonuclear count \> 250 in ascitic fluid.

Time frame: 24 weeks

Survival in both groups after development of SBP (Spontaneous Bacterial Peritonitis ).

Spontaneous Bacterial Peritonitis is defined as Polymorphonuclear count \> 250 in ascitic fluid.

Time frame: 48 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.