Meropenem vs Cefotaxime as Empirical Treatment of SBP
1 other identifier
interventional
286
0 countries
N/A
Brief Summary
We aimed to evaluate whether meropenem is superior to cefotaxime for treatment of SBP empirically.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2023
Shorter than P25 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2022
CompletedFirst Posted
Study publicly available on registry
June 22, 2022
CompletedStudy Start
First participant enrolled
January 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2024
CompletedJune 22, 2022
June 1, 2022
1 year
June 17, 2022
June 17, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Response to treatment within 5 days
The response to therapy is defined as the reduction of polymorphonuclear leukocytes (PMN) count in ascitic fluid more than 25 % from baseline after 48 hours and as a PMN count in ascitic fluid less then 250/mm³ after 5 days
5 days
Study Arms (2)
cefotaxime
EXPERIMENTALceotaxime 2g iv /8hr
meropenem
EXPERIMENTALmeropenem 1g iv /8hr
Interventions
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.
Eligibility Criteria
You may qualify if:
- Liver cirrhosis patients with ascites Ascitic fluid PMN cell count \>250/mm3 Age: 18:80
You may not qualify if:
- : history of abdominal surgery within 4 weeks, secondary peritonitis, tuberculous peritonitis, Malignant tumor, patients who use hormones or immunosuppressants, AIDS patients.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (4)
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.
PMID: 28876707RESULTSarwar 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.
PMID: 30881387RESULTWiest 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.
PMID: 22147550RESULTAmeer 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/
PMID: 28846337RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- doctor
Study Record Dates
First Submitted
June 17, 2022
First Posted
June 22, 2022
Study Start
January 1, 2023
Primary Completion
January 1, 2024
Study Completion
February 1, 2024
Last Updated
June 22, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will share