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

• Sponsor: Institute of Liver and Biliary Sciences, India (Other)
• Overall Status: Completed
• CT.gov ID: NCT03702426
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 2
• Actual Duration (Months): 12.3
• Patients Per Site Per Month: 9.8

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Spontaneous Bacterial Peritonitis	Drug: GMCSF; Drug: Norfloxacin	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jul 23, 2018
• Actual Primary Completion Date: Jul 31, 2019
• Actual Study Completion Date: Jul 31, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. Survival in both groups after development of SBP (Spontaneous Bacterial Peritonitis ). [4 weeks]

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

2. Survival in both groups after development of SBP (Spontaneous Bacterial Peritonitis ). [12 weeks]

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

3. Survival in both groups after development of SBP (Spontaneous Bacterial Peritonitis ). [24 weeks]

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

4. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of Liver & Biliary Sciences	New Delhi	Delhi	India	110070

Sponsors and Collaborators

• Institute of Liver and Biliary Sciences, India

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Institute of Liver and Biliary Sciences, India
• ClinicalTrials.gov Identifier: NCT03702426
• Other Study ID Numbers: ILBS-SBP-01
• First Posted: Oct 11, 2018
• Last Update Posted: Oct 24, 2019
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Peritonitis; Norfloxacin

Study Results

No Results Posted as of Oct 24, 2019