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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Institute of Liver and Biliary Sciences, India
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier:
NCT01852630
First received: December 6, 2012
Last updated: December 14, 2013
Last verified: December 2013
  Purpose
  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).

Condition Intervention
Spontaneous Bacterial Peritonitis (SBP).
Drug: cefepime + Albumin
Drug: Imipenem + Albumin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Comparative Open Label Study of Imipenem Versus Cefepime in Spontaneous Bacterial Peritonitis and to Evaluate the Risk Factors for Treatment Failure.

Resource links provided by NLM:


Further study details as provided by Institute of Liver and Biliary Sciences, India:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Survival [ Time Frame: 15 days,1 month and 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: December 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cefepime + Albumin
cefepime 1g iv 8 hourly + Albumin will be given for 2 days.
Drug: Imipenem + Albumin
Imipenem + Albumin will be given for 2 days.
Active Comparator: Imipenem + Albumin
Imipenem 1g iv 8 hourly + Albumin will be given for 2 days.
Drug: cefepime + Albumin
cefepime + Albumin will be given for 2 days

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01852630

Contacts
Contact: Dr Ankur Jindal, MD +91-9582670984 ankur.jindal3@gmail.com

Locations
India
Institute of Liver & Biliary Sciences (ILBS) Recruiting
New Delhi, Delhi, India, 110070
Principal Investigator: Ankur Jindal, MD         
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India
Investigators
Principal Investigator: Dr Ankur Jindal, MD Institute of Liver & Biliary Sciences (ILBS)
  More Information

No publications provided

Responsible Party: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier: NCT01852630     History of Changes
Other Study ID Numbers: ILBS- SBP-001
Study First Received: December 6, 2012
Last Updated: December 14, 2013
Health Authority: India: Ministry of Health

Additional relevant MeSH terms:
Peritonitis
Intraabdominal Infections
Infection
Peritoneal Diseases
Digestive System Diseases
Imipenem
Cefepime
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014