Meropenem vs Cefotaxime as Empirical Treatment of SBP

Assiut University

Status and phase: Not yet enrolling; Phase 4

Conditions: Spontaneous Bacterial Peritonitis

Treatments: Drug: cefotaxime

Study type: Interventional

Funder types: Other

Identifiers

NCT05427747

Meropenem vs cefotaxime in SBP

Details and patient eligibility

About

We aimed to evaluate whether meropenem is superior to cefotaxime for treatment of SBP empirically.

Full description

Ascites is the most frequent complication of cirrhosis and represents a significant change for the patient because the impact on mortality and quality of life is important.

Spontaneous bacterial peritonitis (SBP) is a dreaded complication in patients with decompensated cirrhosis.

Spontaneous bacterial peritonitis (SBP) is the most frequent and life-threatening infection in patients with liver cirrhosis requiring prompt recognition and treatment. It is defined by the presence of >250 polymorphonuclear cells (PMN)/mm3 in ascites in the absence of an intra-abdominal source of infection or malignancy.

Spontaneous bacterial peritonitis carries a mortality rate of 30 to 70% in patients with end-stage liver and kidney disease.

Choice of antibiotic is dependent on type of microbes responsible for infection. Gram negative enteric bacteria are considered the most common pathogens responsible for SBP. This is the reason, 3rd generation cephalosporins are the recommended drugs of choice for treating SBP empirically. But recent studies have shown that Cephalosporins are effective only in 70% of community acquired and 56% of hospital acquired SBP.It is most likely due to changing bacterial pathogens of SBP over last two decades as now gram positive bacteria and multi drug resistance organism (MDRO) are increasingly being isolated in SBP. It is the consequence of undue, over the counter misuse of cephalosporins in community and frequent exposure of cirrhosis patients to these drugs during recurrent hospital admissions.

Enrollment: 286 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Liver cirrhosis patients with ascites Ascitic fluid PMN cell count >250/mm3 Age: 18:80

Exclusion criteria

• : history of abdominal surgery within 4 weeks, secondary peritonitis, tuberculous peritonitis, Malignant tumor, patients who use hormones or immunosuppressants, AIDS patients.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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286 participants in 2 patient groups

cefotaxime

Experimental group

Description:

ceotaxime 2g iv /8hr

Treatment:

Drug: cefotaxime

meropenem

Experimental group

Description:

meropenem 1g iv /8hr

Treatment:

Drug: cefotaxime