Meropenem vs Cefotaxime as Empirical Treatment of SBP
Primary Purpose
Spontaneous Bacterial Peritonitis
Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
cefotaxime
Sponsored by
About this trial
This is an interventional treatment trial for Spontaneous Bacterial Peritonitis
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
cefotaxime
meropenem
Arm Description
ceotaxime 2g iv /8hr
meropenem 1g iv /8hr
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05427747
Brief Title
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
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2023 (Anticipated)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spontaneous Bacterial Peritonitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
286 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
cefotaxime
Arm Type
Experimental
Arm Description
ceotaxime 2g iv /8hr
Arm Title
meropenem
Arm Type
Experimental
Arm Description
meropenem 1g iv /8hr
Intervention Type
Drug
Intervention Name(s)
cefotaxime
Other Intervention Name(s)
meropenem
Intervention Description
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.
Primary Outcome Measure Information:
Title
Response to treatment within 5 days
Description
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
Time Frame
5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Taha hussein Abdelrahman, resident
Phone
+201114236391
Ext
+201068012930
Email
elsheriftaha74@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
28876707
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.
Results Reference
result
PubMed Identifier
30881387
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.
Results Reference
result
PubMed Identifier
22147550
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. Erratum In: Gut. 2012 Apr;61(4):636.
Results Reference
result
PubMed Identifier
28846337
Citation
Ameer MA, Foris LA, Mandiga P, Haseeb M. Spontaneous Bacterial Peritonitis. 2023 Aug 8. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK448208/
Results Reference
result
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Meropenem vs Cefotaxime as Empirical Treatment of SBP
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