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

Primary Purpose

Spontaneous Bacterial Peritonitis

Status

Completed

Phase

Not Applicable

Locations

India

Study Type

Interventional

Intervention

GMCSF

Norfloxacin

About this trial

This is an interventional treatment trial for Spontaneous Bacterial Peritonitis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Institute of Liver & Biliary Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Norfloxacin with GM-CSF

Norfloxacin

Arm 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

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

Outcomes

Primary Outcome Measures

Spontaneous Bacterial Peritonitis on secondary prophylaxis in both groups

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

Secondary Outcome Measures

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

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

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

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

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

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

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

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

Full Information

NCT ID

NCT03702426

First Posted

September 24, 2018

Last Updated

October 22, 2019

Sponsor

Institute of Liver and Biliary Sciences, India

1. Study Identification

Unique Protocol Identification Number

NCT03702426

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Completed

Study Start Date

July 23, 2018 (Actual)

Primary Completion Date

July 31, 2019 (Actual)

Study Completion Date

July 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institute of Liver and Biliary Sciences, India

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spontaneous Bacterial Peritonitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Norfloxacin with GM-CSF

Arm Type

Experimental

Arm 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

Arm Title

Norfloxacin

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

GMCSF

Intervention Description

GMCSF 1.5mcg/Kg

Intervention Type

Drug

Intervention Name(s)

Norfloxacin

Intervention Description

Tablet Norfloxacin 400 mg

Primary Outcome Measure Information:

Title

Spontaneous Bacterial Peritonitis on secondary prophylaxis in both groups

Description

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

Time Frame

6 Month

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

4 weeks

Title

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

Description

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

Time Frame

12 weeks

Title

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

Description

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

Time Frame

24 weeks

Title

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

Description

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

Time Frame

48 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Institute of Liver & Biliary Sciences

City

New Delhi

State/Province

Delhi

ZIP/Postal Code

110070

Country

India

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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