Is Spontaneous Bacterial Peritonitis Still Responding to 3rd Generation Cephalosporins?
NCT ID: NCT02443285
Last Updated: 2017-06-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
100 participants
INTERVENTIONAL
2015-01-31
2019-12-31
Brief Summary
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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 .
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Cefotaxime
cefotaxime 2gm every 12 hours daily for 5 days
Cefotaxime
Cefotaxime 2 gram every12 hours for 5 days
Ceftriaxone
ceftriaxone 2 gm every 24 hours for 5 days.
ceftriaxone
Ceftriaxone 2 gm every 24 hours for 5 days
Interventions
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Cefotaxime
Cefotaxime 2 gram every12 hours for 5 days
ceftriaxone
Ceftriaxone 2 gm every 24 hours for 5 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Tanta University
OTHER
Responsible Party
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Sherief Abd-Elsalam
PI
Principal Investigators
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Sherief M Abd-elsalam, lecturer
Role: PRINCIPAL_INVESTIGATOR
hepatology dept-Tanta
Hanan H Soliman, Professor
Role: STUDY_DIRECTOR
hepatology dept-Tanta
Walaa A Elkhalawany, lecturer
Role: STUDY_CHAIR
hepatology dept-Tanta
Locations
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Tanta university - faculty of medicine
Cairo, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SBP TREATMENT
Identifier Type: -
Identifier Source: org_study_id
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