NCT05427747

Meropenem vs Cefotaxime as Empirical Treatment of SBP

Meropenem vs Cefotaxime as Empirical Treatment of Spontaneous Bacterial Peritonitis :Prospective Randomized Clinical Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 286 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Spontaneous Bacterial Peritonitis

Interventions

Type	Name	Description
DRUG	cefotaxime	One group will be given cefotaxime and another group meropenem. The efficacy of antibiotic therapy will be checked with: * Follow-up paracentesis after 48 hours of initiation of empiric antibiotic treatment showing reduction in neutrophil count of at least 25% . * Decrease of peritoneal fluid PMN count to \< 250 cells/μ at end of treatment and negative previously positive ascitic fluid culture.

Timeline

• Start date: 2023-01-01
• Primary completion: 2024-01-01
• Completion: 2024-02-01
• First posted: 2022-06-22
• Last updated: 2022-06-22