Clinical trial NCT02443285: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Primary Bacterial Peritonitis
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2015-05-13
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Liver cirrhosis with ascites and SBP

Exclusion Criteria:

* ascitic fluid with polymicrobial infections

Primary outcomes:
measure: number of patients with clearence of infection
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Tanta university - faculty of medicine
Study officials:
affiliation: hepatology dept-Tanta
name: Sherief M Abd-elsalam, lecturer
role: PRINCIPAL_INVESTIGATOR
affiliation: hepatology dept-Tanta
name: Hanan H Soliman, Professor
role: STUDY_DIRECTOR
affiliation: hepatology dept-Tanta
name: Walaa A Elkhalawany, lecturer
role: STUDY_CHAIR
References: