Imipenem Versus Cefepime in Spontaneous Bacterial Peritonitis and to Evaluate the Risk Factors for Treatment Failure
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|ClinicalTrials.gov Identifier: NCT01852630|
Recruitment Status : Completed
First Posted : May 14, 2013
Last Update Posted : November 22, 2016
- 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.
- 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.
- However, other SBP (Spontaneous Bacterial Peritonitis) patients not included for randomization will be given empirical therapy with 3rd generation cephalosporin (ceftriaxone).
|Condition or disease||Intervention/treatment||Phase|
|Spontaneous Bacterial Peritonitis||Drug: cefepime + Albumin Drug: Imipenem + Albumin||Not Applicable|
Baseline clinical, laboratory and disease severity parameters will be evaluated for each study patient.
- Etiology of cirrhosis.
- 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
- Decompensations/complications of CLD (Chronic Liver Disease) UGI bleed, Hepatic encephalopathy, AKI (Acute Kidney Injury) etc.
- 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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||175 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
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
- 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 ]
- Survival [ Time Frame: 15 days,1 month and 3 months ]
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): NCT01852630
|Institute of Liver & Biliary Sciences (ILBS)|
|New Delhi, Delhi, India, 110070|
|Principal Investigator:||Dr Ankur Jindal, MD||Institute of Liver & Biliary Sciences (ILBS)|