To Compare the Efficacy of Carbepenem Versus Carbepenem Plus GM-CSF in Difficult To Treat Spontaneous Bacterial Peritonitis

I

Institute of Liver and Biliary Sciences, India

Status

Completed

Conditions

Spontaneous Bacterial Peritonitis

Treatments

Drug: Albumin
Drug: GMCSF (of Granulocyte-Monocyte Colony-Stimulating Factor) .
Drug: Carbepenem

Study type

Interventional

Funder types

Other

Identifiers

NCT02468089
ILBS-SBP-001

Details and patient eligibility

About

A Minimum of 150 consecutive patients of decompensated cirrhosis of any etiology, presenting to the Institute of Liver and Biliary Sciences hospital with a diagnosis of difficult to treat SBP will be included and randomized into two treatment groups. Group A - Carbepenem+albumin Group B - Carbepenem+albumin+GMCSF.

Enrollment

146 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age more than 18 years

Patients of decompensated liver cirrhosis who present with- Spontaneous bacterial peritonitis (Presence of more than 250 neutrophils per cc of ascetic fluid, in the absence of a surgical abdomen, in the presence of decompensated cirrhosis and portal hypertension) that is not responding to initial therapy- DTT-SBP:

  • Hospital acquired - New onset SBP (Spontaneous bacterial peritonitis) after 48 h of hospitalization.
  • Recurrent SBP - One or more prior episode(s) of SBP in year.
  • Antibiotic resistant - Resistance to 3rd Gen Cephalosporin in last 3 m.
  • Antibiotic non-response -Non-response to 3rd Gen Cephalosporin, sepsis on 3rd Gen Cephalosporin.

Exclusion criteria

  • < 18 years.
  • Advanced HCC (HepatoCellular Carcinoma)
  • Post liver transplant
  • HIV + ve, Immunosuppressive therapy
  • Pregnancy
  • Domiciliary treatment
  • No consent

Trial design

146 participants in 2 patient groups

Carbepenem+albumin+GMCSF.
Experimental group
Treatment:
Drug: Carbepenem
Drug: GMCSF (of Granulocyte-Monocyte Colony-Stimulating Factor) .
Drug: Albumin
Carbepenem+albumin
Active Comparator group
Treatment:
Drug: Carbepenem
Drug: Albumin

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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