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

Spontaneous Bacterial Peritonitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02468089
• Other study ID #: ILBS-SBP-001
• Status: Completed
• Phase: N/A
• First received: May 22, 2015
• Last updated: November 2, 2017
• Start date: May 1, 2015
• Est. completion date: August 31, 2017

Study information

• Verified date: January 2017
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: August 31, 2017
• Est. primary completion date: August 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peritonitis
• Spontaneous Bacterial Peritonitis

Intervention

Drug:
• Carbepenem

• Albumin

• GMCSF (of Granulocyte-Monocyte Colony-Stimulating Factor) .

Locations

Country	Name	City	State
India	Institute of Liver and Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total no of patients cured from SBP (Spontaneous Bacterial Peritonitis)		1 week
Secondary	Survival at week 2		week 2
Secondary	Survival at week 4		week 4
Secondary	Survival at week 12		week 12
Secondary	Total number of patients develop variceal bleed.		1 week
Secondary	Total number of patients develop non-SBP (Spontaneous Bacterial Peritonitis) infections within 1 wk of enrolment.		1 week
Secondary	Total number of patients develop HE (Hepatic Encephalopathy).		1 week
Secondary	Total number of patients develop AKI (Acute kidney Injury).		1 week