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

T

Tanta University

Status and phase

Unknown
Phase 3

Conditions

Primary Bacterial Peritonitis

Treatments

Drug: ceftriaxone
Drug: Cefotaxime

Study type

Interventional

Funder types

Other

Identifiers

NCT02443285
SBP TREATMENT

Details and patient eligibility

About

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 .

Full 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.

Enrollment

100 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Liver cirrhosis with ascites and SBP

Exclusion criteria

  • ascitic fluid with polymicrobial infections

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

100 participants in 2 patient groups

Cefotaxime
Active Comparator group
Description:
cefotaxime 2gm every 12 hours daily for 5 days
Treatment:
Drug: Cefotaxime
Ceftriaxone
Active Comparator group
Description:
ceftriaxone 2 gm every 24 hours for 5 days.
Treatment:
Drug: ceftriaxone

Trial contacts and locations

1

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Central trial contact

Sherief M Abd-elsalam; Sherief M Abd-elsalam, lecturer

Data sourced from clinicaltrials.gov

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