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

Not Applicable

Completed

• Conditions: Spontaneous Bacterial Peritonitis
• Interventions: Drug: GMCSF; Drug: Norfloxacin

• Registration Number: NCT03702426
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-23
• Study First Submitted: 2018-09-24
• Study First Submitted QC: 2018-10-08
• Study First Posted: 2018-10-11
• Primary Completion: 2019-07-31
• Study Completion: 2019-07-31
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-22
• Last Update Posted: 2019-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Norfloxacin with GM-CSF	GMCSF	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
Norfloxacin with GM-CSF	Norfloxacin	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
Norfloxacin	Norfloxacin	Patients who fulfil the inclusion criteria will receive oral norfloxacin 400 mg daily as secondary prophylaxis for SBP in Group A.

Primary Outcome Measures

Name	Time	Method
Spontaneous Bacterial Peritonitis on secondary prophylaxis in both groups	6 Month	Spontaneous Bacterial Peritonitis is defined as Polymorphonuclear count \> 250 in ascitic fluid

Secondary Outcome Measures

Name	Time	Method
Survival in both groups after development of SBP (Spontaneous Bacterial Peritonitis ).	48 weeks	Spontaneous Bacterial Peritonitis is defined as Polymorphonuclear count \> 250 in ascitic fluid.

Trial Locations

Locations (1)

Institute of Liver & Biliary Sciences; 🇮🇳 New Delhi, Delhi, India