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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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spontaneous Bacterial Peritonitis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    June 17, 2022
    Last Updated
    June 17, 2022
    Sponsor
    Assiut University
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    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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