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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03702426
Recruitment Status : Completed
First Posted : October 11, 2018
Last Update Posted : October 24, 2019
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : July 23, 2018
Actual Primary Completion Date : July 31, 2019
Actual Study Completion Date : July 31, 2019
Arms and Interventions
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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
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Primary Outcome Measures :
  1. Spontaneous Bacterial Peritonitis on secondary prophylaxis in both groups [ Time Frame: 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 ). [ Time Frame: 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 ). [ Time Frame: 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 ). [ Time Frame: 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 ). [ Time Frame: 48 weeks ]
    Spontaneous Bacterial Peritonitis is defined as Polymorphonuclear count > 250 in ascitic fluid.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03702426


Locations
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India
Institute of Liver & Biliary Sciences
New Delhi, Delhi, India, 110070
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India
More Information
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Responsible Party: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier: NCT03702426    
Other Study ID Numbers: ILBS-SBP-01
First Posted: October 11, 2018    Key Record Dates
Last Update Posted: October 24, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Peritonitis
Intraabdominal Infections
Infections
Peritoneal Diseases
Digestive System Diseases
Norfloxacin
Anti-Bacterial Agents
Anti-Infective Agents
 Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors