Meropenem vs Cefotaxime as Empirical Treatment of SBP

NCT ID: NCT05427747

Last Updated: 2022-06-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 286 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2024-02-29

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.

Conditions

Spontaneous Bacterial Peritonitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

cefotaxime

ceotaxime 2g iv /8hr

Group Type: EXPERIMENTAL

cefotaxime

Intervention Type: DRUG

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.

meropenem

meropenem 1g iv /8hr

Group Type: EXPERIMENTAL

cefotaxime

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

meropenem

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Taha Hussein Kawashty Abdelrahman

doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Taha hussein Abdelrahman, resident

Role: CONTACT

elsheriftaha74@gmail.com

+201114236391 ext. +201068012930

References

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.

Reference Type: RESULT

PMID: 28876707 (View on PubMed)

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.

Reference Type: RESULT

PMID: 30881387 (View on PubMed)

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.

Reference Type: RESULT

PMID: 22147550 (View on PubMed)

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/

Reference Type: RESULT

PMID: 28846337 (View on PubMed)

Other Identifiers

Meropenem vs cefotaxime in SBP

Identifier Type: -

Identifier Source: org_study_id