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Imipenem Versus Cefepime in Spontaneous Bacterial Peritonitis and to Evaluate the Risk Factors for Treatment Failure

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: NCT01852630
Recruitment Status : Completed
First Posted : May 14, 2013
Last Update Posted : November 22, 2016
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India

Tracking Information
First Submitted Date  ICMJE December 6, 2012
First Posted Date  ICMJE May 14, 2013
Last Update Posted Date November 22, 2016
Study Start Date  ICMJE December 2012
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2013)
The primary outcome of the study is the Response to treatment in each intervention group. Response is defined as 25% reduction in ANC (Absolute Neutrophil Count) from baseline. [ Time Frame: 2 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2013)
Survival [ Time Frame: 15 days,1 month and 3 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Imipenem Versus Cefepime in Spontaneous Bacterial Peritonitis and to Evaluate the Risk Factors for Treatment Failure
Official Title  ICMJE A Randomized, Comparative Open Label Study of Imipenem Versus Cefepime in Spontaneous Bacterial Peritonitis and to Evaluate the Risk Factors for Treatment Failure.
Brief Summary
  1. All consecutive patients with Cirrhosis and ascites admitted to ILBS (Institute of Liver & Biliary Sciences) will be evaluated for the presence of SBP (Spontaneous Bacterial Peritonitis) by ascitic fluid examination at admission.
  2. SBP (Spontaneous Bacterial Peritonitis) will be diagnosed in the presence of absolute neutrophil count (ANC >250/mm3) with/without positive ascitic fluid culture and Patients with SBP (Spontaneous Bacterial Peritonitis) included in the study will be randomized to receive cefepime or imipenem.
  3. However, other SBP (Spontaneous Bacterial Peritonitis) patients not included for randomization will be given empirical therapy with 3rd generation cephalosporin (ceftriaxone).
Detailed Description

Baseline evaluation:

Baseline clinical, laboratory and disease severity parameters will be evaluated for each study patient.

  1. Etiology of cirrhosis.
  2. Severity of liver disease. CTP (Child-Turcotte-Pugh) score MELD (Model for End-stage Liver Disease) score MELD (Model for End-stage Liver Disease)-Na score IMSAA score
  3. Decompensations/complications of CLD (Chronic Liver Disease) UGI bleed, Hepatic encephalopathy, AKI (Acute Kidney Injury) etc.
  4. Laboratory investigations:

Serum electrolytes Liver function tests Kidney function tests Pro calcitonin USG/CT abdomen Complete blood counts Coagulation parameters Ascitic fluid analysis- TLC, DLC, Protein, sugar, culture, SAAG. Chest X ray PA view HBsAg and Anti-HCV and other etiological workup as available.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Spontaneous Bacterial Peritonitis
Intervention  ICMJE
  • Drug: cefepime + Albumin
    cefepime + Albumin will be given for 2 days
  • Drug: Imipenem + Albumin
    Imipenem + Albumin will be given for 2 days.
Study Arms  ICMJE
  • Experimental: cefepime + Albumin
    cefepime 1g iv 8 hourly + Albumin will be given for 2 days.
    Intervention: Drug: Imipenem + Albumin
  • Active Comparator: Imipenem + Albumin
    Imipenem 1g iv 8 hourly + Albumin will be given for 2 days.
    Intervention: Drug: cefepime + Albumin
Publications * Jindal A, Kumar M, Bhadoria AS, Maiwall R, Sarin SK. A randomized open label study of 'imipenem vs. cefepime' in spontaneous bacterial peritonitis. Liver Int. 2016 May;36(5):677-87. doi: 10.1111/liv.12985. Epub 2015 Nov 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 21, 2016)
175
Original Estimated Enrollment  ICMJE
 (submitted: May 9, 2013)
60
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

- Cirrhotic Patients with SBP (Spontaneous Bacterial Peritonitis) having any of the following risk factors would be considered as 'Difficult to Treat SBP' and would be included -

  1. Nosocomial SBP: occurence of SBP (Spontaneous Bacterial Peritonitis) after 48 hours of hospital admission, or
  2. Prior ascitic fluid infection with 3rd generation cephalosporin resistant organism, or
  3. No response to treatment with 3rd generation cephalosporins after 48 hours.

Exclusion Criteria:

  1. Age less than 18 years.
  2. Cirrhotics with SBP (Spontaneous Bacterial Peritonitis) managed as outpatients.
  3. Post liver transplant, HIV patients.
  4. Patients on systemic chemotherapy, immunosuppressant drugs.
  5. Growth of bacteria resistant to intervention drugs in ascitic fluid culture.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01852630
Other Study ID Numbers  ICMJE ILBS- SBP-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Institute of Liver and Biliary Sciences, India
Study Sponsor  ICMJE Institute of Liver and Biliary Sciences, India
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dr Ankur Jindal, MD Institute of Liver & Biliary Sciences (ILBS)
PRS Account Institute of Liver and Biliary Sciences, India
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP