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

NCT01852630 | Completed

• 1 other identifier: ILBS- SBP-01
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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. 3.However, other SBP (Spontaneous Bacterial Peritonitis) patients not included for randomization will be given empirical therapy with 3rd generation cephalosporin (ceftriaxone).

Conditions

Spontaneous Bacterial Peritonitis

Outcome Measures

Primary Outcomes (1)

• 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.

  2 days

Secondary Outcomes (1)

• Survival

  15 days,1 month and 3 months

Study Arms (2)

cefepime + Albumin

EXPERIMENTAL

cefepime 1g iv 8 hourly + Albumin will be given for 2 days.

Drug: Imipenem + Albumin

Imipenem + Albumin

ACTIVE COMPARATOR

Imipenem 1g iv 8 hourly + Albumin will be given for 2 days.

Drug: cefepime + Albumin

Interventions

cefepime + Albumin DRUG

cefepime + Albumin will be given for 2 days

Imipenem + Albumin

Imipenem + Albumin DRUG

Imipenem + Albumin will be given for 2 days.

cefepime + Albumin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Age less than 18 years.
• Cirrhotics with SBP (Spontaneous Bacterial Peritonitis) managed as outpatients.
• Post liver transplant, HIV patients.
• Patients on systemic chemotherapy, immunosuppressant drugs.
• Growth of bacteria resistant to intervention drugs in ascitic fluid culture.

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences (ILBS)

New Delhi, National Capital Territory of Delhi, 110070, India

Location

Related Publications (1)

• 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.

  PMID: 26474358 DERIVED

MeSH Terms

Interventions

Cefepime; Albumins; Imipenem

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Proteins; Amino Acids, Peptides, and Proteins; Thienamycins; Carbapenems

Study Officials

• Dr Ankur Jindal, MD

  Institute of Liver & Biliary Sciences (ILBS)

  PRINCIPAL INVESTIGATOR

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: December 6, 2012
• First Posted: May 14, 2013
• Study Start: December 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: November 22, 2016

Record last verified: 2016-07

Locations

IN (1)