Clinical trial NCT05427747: Meropenem vs Cefotaxime as Empirical Treatment of SBP
Official title: Meropenem vs Cefotaxime as Empirical Treatment of Spontaneous Bacterial Peritonitis :Prospective Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Spontaneous Bacterial Peritonitis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-06-22
Enrollment: 286
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Response to treatment within 5 days
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Finci L, Mouraux S, Knuchel J, Bochatay L. [Initial management of new onset ascites in patient with cirrhosis]. Rev Med Suisse. 2017 Sep 6;13(573):1509-1515. French.
citation: Sarwar S, Tarique S, Waris U, Khan AA. Cephalosporin resistance in community acquired spontaneous bacterial peritonitis. Pak J Med Sci. 2019 Jan-Feb;35(1):4-9. doi: 10.12669/pjms.35.1.17.
citation: Wiest R, Krag A, Gerbes A. Spontaneous bacterial peritonitis: recent guidelines and beyond. Gut. 2012 Feb;61(2):297-310. doi: 10.1136/gutjnl-2011-300779. Epub 2011 Dec 6. No abstract available.
citation: Ameer MA, Foris LA, Mandiga P, Haseeb M. Spontaneous Bacterial Peritonitis(Archived). 2023 Aug 8. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK448208/