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Completed

NCT Number: NCT03702426

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

-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

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Key information

Conditions

Spontaneous Bacterial Peritonitis

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GMCSF

Drug

GMCSF 1.5mcg/Kg

Norfloxacin

Drug

Tablet Norfloxacin 400 mg

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Institute of Liver and Biliary Sciences, India

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 11, 2018
Registry last updated
Oct 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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