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

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: July 31, 2019

Interventions

  • Drug: GMCSF
    • GMCSF 1.5mcg/Kg
  • Drug: Norfloxacin
    • Tablet Norfloxacin 400 mg

Arms, Groups and Cohorts

  • Experimental: Norfloxacin with GM-CSF
    • 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
  • Active Comparator: Norfloxacin
    • Patients who fulfil the inclusion criteria will receive oral norfloxacin 400 mg daily as secondary prophylaxis for SBP in Group A.

Clinical Trial Outcome Measures

Primary Measures

  • Spontaneous Bacterial Peritonitis on secondary prophylaxis in both groups
    • Time Frame: 6 Month
    • Spontaneous Bacterial Peritonitis is defined as Polymorphonuclear count > 250 in ascitic fluid

Secondary Measures

  • Survival in both groups after development of SBP (Spontaneous Bacterial Peritonitis ).
    • Time Frame: 4 weeks
    • Spontaneous Bacterial Peritonitis is defined as Polymorphonuclear count > 250 in ascitic fluid.
  • Survival in both groups after development of SBP (Spontaneous Bacterial Peritonitis ).
    • Time Frame: 12 weeks
    • Spontaneous Bacterial Peritonitis is defined as Polymorphonuclear count > 250 in ascitic fluid.
  • Survival in both groups after development of SBP (Spontaneous Bacterial Peritonitis ).
    • Time Frame: 24 weeks
    • Spontaneous Bacterial Peritonitis is defined as Polymorphonuclear count > 250 in ascitic fluid.
  • Survival in both groups after development of SBP (Spontaneous Bacterial Peritonitis ).
    • Time Frame: 48 weeks
    • Spontaneous Bacterial Peritonitis is defined as Polymorphonuclear count > 250 in ascitic fluid.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Institute of Liver and Biliary Sciences, India
  • Provider of Information About this Clinical Study
    • Sponsor

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