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

Institute of Liver and Biliary Sciences, India

Status: Completed

Conditions: Spontaneous Bacterial Peritonitis

Treatments: Drug: Norfloxacin; Drug: GMCSF

Study type: Interventional

Funder types: Other

Identifiers

NCT03702426

ILBS-SBP-01

Details and patient eligibility

About

-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

Enrollment: 120 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups

Norfloxacin with GM-CSF

Experimental group

Description:

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

Treatment:

Drug: GMCSF

Drug: Norfloxacin

Norfloxacin

Active Comparator group

Description:

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

Treatment:

Drug: Norfloxacin