A Phase 3 interventional study of Cefotaxime and ceftriaxone in Primary Bacterial Peritonitis, sponsored by Tanta University. Status unknown at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2017-06-20.
Sponsored by Tanta University · Phase 3, Interventional, and Treatment
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 .
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.
185 studies on the registry are indexed under Peritonitis; 25 are open to participants now.
This study's planned enrollment of 100 is close to the median of 95 across 118 interventional studies indexed under Peritonitis.
Browse Peritonitis studies →Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
cefotaxime 2gm every 12 hours daily for 5 days
Drug: Cefotaxime
ceftriaxone 2 gm every 24 hours for 5 days.
Drug: ceftriaxone
Cefotaxime 2 gram every12 hours for 5 days
Also known as: claforan, cefotax
Ceftriaxone 2 gm every 24 hours for 5 days
Also known as: rocephin, cefaxone
number of patients with clearence of infection
number of patients having clearence of infection
Time frame: 5 days
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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Tanta University