Is Spontaneous Bacterial Peritonitis Still Responding to 3rd Generation Cephalosporins?
Primary Purpose
Primary Bacterial Peritonitis
Status
Unknown status
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Cefotaxime
ceftriaxone
Sponsored by
About this trial
This is an interventional treatment trial for Primary Bacterial Peritonitis
Eligibility Criteria
Inclusion Criteria:
- Liver cirrhosis with ascites and SBP
Exclusion Criteria:
- ascitic fluid with polymicrobial infections
Sites / Locations
- Tanta university - faculty of medicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Cefotaxime
Ceftriaxone
Arm Description
cefotaxime 2gm every 12 hours daily for 5 days
ceftriaxone 2 gm every 24 hours for 5 days.
Outcomes
Primary Outcome Measures
number of patients with clearence of infection
number of patients having clearence of infection
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02443285
Brief Title
Is Spontaneous Bacterial Peritonitis Still Responding to 3rd Generation Cephalosporins?
Official Title
Is Spontaneous Bacterial Peritonitis Still Responding to 3rd Generation Cephalosporins?
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Current European and most other international guidelines recommend the use of a third-generation cephalosporin as the first choice, or amoxicillin-clavulanate acid or fluoroquinolones as an alternative choice .
These recommendations are based mainly on clinical trials that were very often conducted a decade or more ago, and on the assumption that E. coli would be involved in nearly half of the cases.
The microbial etiology of SBP remains relatively constant; however, the antibiotic resistance rate especially for third-generation cephalosporins (including cefotaxime and ceftazidime), ciprofloxacin, and ofloxacin increased dramatically .
Detailed Description
Spontaneous bacterial peritonitis (SBP), defined as an infection of ascites in the absence of a contiguous source of infection.
Spontaneous bacterial peritonitis (SBP) is a common and potentially fatal bacterial infection in patients with cirrhosis and ascites, occurring in 10 to 30% of patients, with in-hospital mortality rates ranging from 20 to 30% .
It is secondary to impaired humoral and cellular immune responses that result in indirect intestinal bacterial translocation into the ascitic fluid .
SBP is also associated with a poor long-term prognosis for patients, as mortality rates can reach 50 to 70% at 1 year .
Early diagnosis and early optimal treatment of these infections with appropriate antibiotics and the prevention of hepatorenal syndrome with albumin are required .
Current European and most other international guidelines recommend the use of a third-generation cephalosporin as the first choice, or amoxicillin-clavulanate acid or fluoroquinolones as an alternative choice.
These recommendations are based mainly on clinical trials that were very often conducted a decade or more ago, and on the assumption that E. coli would be involved in nearly half of the cases.
The microbial etiology of SBP remains relatively constant; however, the antibiotic resistance rate especially for third-generation cephalosporins (including cefotaxime and ceftazidime), ciprofloxacin, and ofloxacin increased dramatically.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Bacterial Peritonitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cefotaxime
Arm Type
Active Comparator
Arm Description
cefotaxime 2gm every 12 hours daily for 5 days
Arm Title
Ceftriaxone
Arm Type
Active Comparator
Arm Description
ceftriaxone 2 gm every 24 hours for 5 days.
Intervention Type
Drug
Intervention Name(s)
Cefotaxime
Other Intervention Name(s)
claforan, cefotax
Intervention Description
Cefotaxime 2 gram every12 hours for 5 days
Intervention Type
Drug
Intervention Name(s)
ceftriaxone
Other Intervention Name(s)
rocephin, cefaxone
Intervention Description
Ceftriaxone 2 gm every 24 hours for 5 days
Primary Outcome Measure Information:
Title
number of patients with clearence of infection
Description
number of patients having clearence of infection
Time Frame
5 days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Liver cirrhosis with ascites and SBP
Exclusion Criteria:
ascitic fluid with polymicrobial infections
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sherief M Abd-elsalam
Phone
00201095159522
Email
Sheriefabdelsalam@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sherief M Abd-elsalam, lecturer
Phone
01095159522
Email
Sheriefabdelsalam@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sherief M Abd-elsalam, lecturer
Organizational Affiliation
hepatology dept-Tanta
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hanan H Soliman, Professor
Organizational Affiliation
hepatology dept-Tanta
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Walaa A Elkhalawany, lecturer
Organizational Affiliation
hepatology dept-Tanta
Official's Role
Study Chair
Facility Information:
Facility Name
Tanta university - faculty of medicine
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherief M Abdelsalam, lecturer
Phone
00201095159522
Email
Sheriefabdelsalam@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Is Spontaneous Bacterial Peritonitis Still Responding to 3rd Generation Cephalosporins?
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