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Is Spontaneous Bacterial Peritonitis Still Responding to 3rd Generation Cephalosporins?

Is Spontaneous Bacterial Peritonitis Still Responding to 3rd Generation Cephalosporins?

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02443285
Enrollment
100
Registered
2015-05-13
Start date
2015-01-31
Completion date
2019-12-31
Last updated
2017-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Bacterial Peritonitis

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.

Interventions

DRUGCefotaxime

Cefotaxime 2 gram every12 hours for 5 days

DRUGceftriaxone

Ceftriaxone 2 gm every 24 hours for 5 days

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Liver cirrhosis with ascites and SBP

Exclusion criteria

* ascitic fluid with polymicrobial infections

Design outcomes

Primary

MeasureTime frameDescription
number of patients with clearence of infection5 daysnumber of patients having clearence of infection

Countries

Egypt

Contacts

Primary ContactSherief M Abd-elsalam
Sheriefabdelsalam@yahoo.com00201095159522
Backup ContactSherief M Abd-elsalam, lecturer
Sheriefabdelsalam@yahoo.com01095159522

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026