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

Spontaneous Bacterial Peritonitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03702426
• Other study ID #: ILBS-SBP-01
• Status: Completed
• Phase: N/A
• Start date: July 23, 2018
• Est. completion date: July 31, 2019

Study information

• Verified date: October 2019
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Peritonitis
• Spontaneous Bacterial Peritonitis

Intervention

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

Locations

Country	Name	City	State
India	Institute of Liver & Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spontaneous Bacterial Peritonitis on secondary prophylaxis in both groups	Spontaneous Bacterial Peritonitis is defined as Polymorphonuclear count > 250 in ascitic fluid	6 Month
Secondary	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
Secondary	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
Secondary	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
Secondary	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