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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02468089

Enrollment

146

Registered

2015-06-10

Start date

2015-05-01

Completion date

2017-08-31

Last updated

2017-11-06

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

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.

Interventions

DRUGCarbepenem

DRUGAlbumin

DRUGGMCSF (of Granulocyte-Monocyte Colony-Stimulating Factor) .

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Age more than 18 years 2. 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

1. \< 18 years. 2. Advanced HCC (HepatoCellular Carcinoma) 3. Post liver transplant 4. HIV + ve, Immunosuppressive therapy 5. Pregnancy 6. Domiciliary treatment 7. No consent

Design outcomes

Primary

Measure	Time frame
Total no of patients cured from SBP (Spontaneous Bacterial Peritonitis)	1 week

Secondary

Measure	Time frame
Survival at week 4	week 4
Survival at week 12	week 12
Total number of patients develop variceal bleed.	1 week
Survival at week 2	week 2
Total number of patients develop HE (Hepatic Encephalopathy).	1 week
Total number of patients develop AKI (Acute kidney Injury).	1 week
Total number of patients develop non-SBP (Spontaneous Bacterial Peritonitis) infections within 1 wk of enrolment.	1 week

Countries

India

Outcome results

None listed

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