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

NCT03702426 | Completed

• 1 other identifier: ILBS-SBP-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

-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

Conditions

Spontaneous Bacterial Peritonitis

Outcome Measures

Primary Outcomes (1)

• Spontaneous Bacterial Peritonitis on secondary prophylaxis in both groups

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

  6 Month

Secondary Outcomes (4)

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

  4 weeks

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

  12 weeks

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

  24 weeks

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

  48 weeks

Study Arms (2)

Norfloxacin with GM-CSF

EXPERIMENTAL

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; Drug: Norfloxacin

Norfloxacin

ACTIVE COMPARATOR

Patients who fulfil the inclusion criteria will receive oral norfloxacin 400 mg daily as secondary prophylaxis for SBP in Group A.

Drug: Norfloxacin

Interventions

GMCSF DRUG

GMCSF 1.5mcg/Kg

Norfloxacin with GM-CSF

Norfloxacin DRUG

Tablet Norfloxacin 400 mg

Norfloxacin; Norfloxacin with GM-CSF

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Interventions

Norfloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2018
• First Posted: October 11, 2018
• Study Start: July 23, 2018
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: October 24, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)