To Compare the Efficacy of Carbepenem Versus Carbepenem Plus GM-CSF in Difficult To Treat Spontaneous Bacterial Peritonitis
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|ClinicalTrials.gov Identifier: NCT02468089|
Recruitment Status : Completed
First Posted : June 10, 2015
Last Update Posted : November 6, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Spontaneous Bacterial Peritonitis||Drug: Carbepenem Drug: Albumin Drug: GMCSF (of Granulocyte-Monocyte Colony-Stimulating Factor) .||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||146 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Study to Compare the Efficacy of Carbepenem Versus Carbepenem Plus GM-CSF in Difficult To Treat Spontaneous Bacterial Peritonitis|
|Actual Study Start Date :||May 1, 2015|
|Actual Primary Completion Date :||August 31, 2017|
|Actual Study Completion Date :||August 31, 2017|
Drug: GMCSF (of Granulocyte-Monocyte Colony-Stimulating Factor) .
|Active Comparator: Carbepenem+albumin||
- Total no of patients cured from SBP (Spontaneous Bacterial Peritonitis) [ Time Frame: 1 week ]
- Survival at week 2 [ Time Frame: week 2 ]
- Survival at week 4 [ Time Frame: week 4 ]
- Survival at week 12 [ Time Frame: week 12 ]
- Total number of patients develop variceal bleed. [ Time Frame: 1 week ]
- Total number of patients develop non-SBP (Spontaneous Bacterial Peritonitis) infections within 1 wk of enrolment. [ Time Frame: 1 week ]
- Total number of patients develop HE (Hepatic Encephalopathy). [ Time Frame: 1 week ]
- Total number of patients develop AKI (Acute kidney Injury). [ Time Frame: 1 week ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02468089
|Institute of Liver and Biliary Sciences|
|New Delhi, Delhi, India, 110070|
|Principal Investigator:||Vikash Prakash, MD||Institute of Liver and Biliary Sciences|