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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02468089
Recruitment Status : Completed
First Posted : June 10, 2015
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India

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.


Condition or disease Intervention/treatment Phase
Spontaneous Bacterial Peritonitis Drug: Carbepenem Drug: Albumin Drug: GMCSF (of Granulocyte-Monocyte Colony-Stimulating Factor) . Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: Carbepenem+albumin+GMCSF. Drug: Carbepenem
Drug: Albumin
Drug: GMCSF (of Granulocyte-Monocyte Colony-Stimulating Factor) .
Active Comparator: Carbepenem+albumin Drug: Carbepenem
Drug: Albumin



Primary Outcome Measures :
  1. Total no of patients cured from SBP (Spontaneous Bacterial Peritonitis) [ Time Frame: 1 week ]

Secondary Outcome Measures :
  1. Survival at week 2 [ Time Frame: week 2 ]
  2. Survival at week 4 [ Time Frame: week 4 ]
  3. Survival at week 12 [ Time Frame: week 12 ]
  4. Total number of patients develop variceal bleed. [ Time Frame: 1 week ]
  5. Total number of patients develop non-SBP (Spontaneous Bacterial Peritonitis) infections within 1 wk of enrolment. [ Time Frame: 1 week ]
  6. Total number of patients develop HE (Hepatic Encephalopathy). [ Time Frame: 1 week ]
  7. Total number of patients develop AKI (Acute kidney Injury). [ Time Frame: 1 week ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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India
Institute of Liver and Biliary Sciences
New Delhi, Delhi, India, 110070
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India
Investigators
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Principal Investigator: Vikash Prakash, MD Institute of Liver and Biliary Sciences
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Responsible Party: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier: NCT02468089    
Other Study ID Numbers: ILBS-SBP-001
First Posted: June 10, 2015    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Peritonitis
Intraabdominal Infections
Infection
Peritoneal Diseases
Digestive System Diseases
Sargramostim
Immunologic Factors
Physiological Effects of Drugs