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

A Randomized, Comparative Open Label Study of Imipenem Versus Cefepime in Spontaneous Bacterial Peritonitis and to Evaluate the Risk Factors for Treatment Failure.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01852630

Enrollment

175

Registered

2013-05-14

Start date

2012-12-31

Completion date

2015-12-31

Last updated

2016-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spontaneous Bacterial Peritonitis

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.

Interventions

DRUGcefepime + Albumin

cefepime + Albumin will be given for 2 days

DRUGImipenem + Albumin

Imipenem + Albumin will be given for 2 days.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Survival	15 days,1 month and 3 months

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026