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
1 other identifier
interventional
146
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 22, 2015
CompletedFirst Posted
Study publicly available on registry
June 10, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2017
CompletedNovember 6, 2017
January 1, 2017
2.3 years
May 22, 2015
November 2, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Total no of patients cured from SBP (Spontaneous Bacterial Peritonitis)
1 week
Secondary Outcomes (7)
Survival at week 2
week 2
Survival at week 4
week 4
Survival at week 12
week 12
Total number of patients develop variceal bleed.
1 week
Total number of patients develop non-SBP (Spontaneous Bacterial Peritonitis) infections within 1 wk of enrolment.
1 week
- +2 more secondary outcomes
Study Arms (2)
Carbepenem+albumin+GMCSF.
EXPERIMENTALCarbepenem+albumin
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- \< 18 years.
- Advanced HCC (HepatoCellular Carcinoma)
- Post liver transplant
- HIV + ve, Immunosuppressive therapy
- Pregnancy
- Domiciliary treatment
- No consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070, India
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vikash Prakash, MD
Institute of Liver and Biliary Sciences
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2015
First Posted
June 10, 2015
Study Start
May 1, 2015
Primary Completion
August 31, 2017
Study Completion
August 31, 2017
Last Updated
November 6, 2017
Record last verified: 2017-01