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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03702426

Enrollment

120

Registered

2018-10-11

Start date

2018-07-23

Completion date

2019-07-31

Last updated

2019-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spontaneous Bacterial Peritonitis

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

Interventions

DRUGGMCSF

GMCSF 1.5mcg/Kg

DRUGNorfloxacin

Tablet Norfloxacin 400 mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Spontaneous Bacterial Peritonitis on secondary prophylaxis in both groups	6 Month	Spontaneous Bacterial Peritonitis is defined as Polymorphonuclear count \> 250 in ascitic fluid

Secondary

Measure	Time frame	Description
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.

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026