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

Study Overview
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Brief Summary
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-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

Official Title
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Comparison of the Efficacy of Granulocyte - Macrophage Colony Stimulating Factor (GM-CSF) and Norfloxacin in Secondary Prophylaxis for Spontaneous Bacterial Peritonitis - A Randomised Controlled Trial

Conditions
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Spontaneous Bacterial Peritonitis

Intervention / Treatment
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* Drug: GMCSF
* Drug: Norfloxacin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Norfloxacin with GM-CSF<br>Oral Norfloxacin 400mg daily and GM-CSF (Granulocyte-Macrophage colony-stimulating factor) in a dose of 1.5mcg/kg over 4 hour infusion every 15 days will be given in Group B | Drug: GMCSF<br>* GMCSF 1.5mcg/Kg<br>Drug: Norfloxacin<br>* Tablet Norfloxacin 400 mg<br>|
| Active Comparator: Norfloxacin<br>Patients who fulfil the inclusion criteria will receive oral norfloxacin 400 mg daily as secondary prophylaxis for SBP in Group A. | Drug: Norfloxacin<br>* Tablet Norfloxacin 400 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spontaneous Bacterial Peritonitis on secondary prophylaxis in both groups | Spontaneous Bacterial Peritonitis is defined as Polymorphonuclear count > 250 in ascitic fluid | 6 Month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival in both groups after development of SBP (Spontaneous Bacterial Peritonitis ). | Spontaneous Bacterial Peritonitis is defined as Polymorphonuclear count > 250 in ascitic fluid. | 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. | 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. | 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. | 48 weeks |