Comparison of the Efficacy of Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) and Norfloxacin in Secondary Prophylaxis for Spontaneous Bacterial Peritonitis
NCT ID: NCT03702426
Last Updated: 2019-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2018-07-23
2019-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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
GMCSF
GMCSF 1.5mcg/Kg
Norfloxacin
Tablet Norfloxacin 400 mg
Norfloxacin
Patients who fulfil the inclusion criteria will receive oral norfloxacin 400 mg daily as secondary prophylaxis for SBP in Group A.
Norfloxacin
Tablet Norfloxacin 400 mg
Interventions
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GMCSF
GMCSF 1.5mcg/Kg
Norfloxacin
Tablet Norfloxacin 400 mg
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Institute of Liver and Biliary Sciences, India
OTHER
Responsible Party
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Locations
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Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, India
Countries
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Other Identifiers
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ILBS-SBP-01
Identifier Type: -
Identifier Source: org_study_id
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