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

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

-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 Overview

• Status: Completed
• Conditions: Spontaneous Bacterial Peritonitis
• Intervention / Treatment: Drug: GMCSF; Drug: Norfloxacin

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110070
      • Institute of Liver & Biliary Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Drug: GMCSF; GMCSF 1.5mcg/Kg; Drug: Norfloxacin; Tablet Norfloxacin 400 mg
Active Comparator: Norfloxacin; Patients who fulfil the inclusion criteria will receive oral norfloxacin 400 mg daily as secondary prophylaxis for SBP in Group A.	Drug: Norfloxacin; Tablet Norfloxacin 400 mg

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2018
• Primary Completion (Actual): July 31, 2019
• Study Completion (Actual): July 31, 2019

Study Registration Dates

• First Submitted: September 24, 2018
• First Submitted That Met QC Criteria: October 8, 2018
• First Posted (Actual): October 11, 2018

Study Record Updates

• Last Update Posted (Actual): October 24, 2019
• Last Update Submitted That Met QC Criteria: October 22, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Peritoneal Diseases; Intraabdominal Infections; Peritonitis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Norfloxacin
• Other Study ID Numbers: ILBS-SBP-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No