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

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ClinicalTrials.gov Identifier: NCT02443285
Recruitment Status : Unknown
Verified June 2017 by Sherief Abd-Elsalam, Tanta University.
Recruitment status was:  Recruiting
First Posted : May 13, 2015
Last Update Posted : June 20, 2017
Sponsor:
Information provided by (Responsible Party):
Sherief Abd-Elsalam, Tanta University

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 .


Condition or disease Intervention/treatment Phase
Primary Bacterial Peritonitis Drug: Cefotaxime Drug: ceftriaxone Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Is Spontaneous Bacterial Peritonitis Still Responding to 3rd Generation Cephalosporins?
Actual Study Start Date : January 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Cefotaxime
cefotaxime 2gm every 12 hours daily for 5 days
Drug: Cefotaxime
Cefotaxime 2 gram every12 hours for 5 days
Other Name: claforan, cefotax

Active Comparator: Ceftriaxone
ceftriaxone 2 gm every 24 hours for 5 days.
Drug: ceftriaxone
Ceftriaxone 2 gm every 24 hours for 5 days
Other Name: rocephin, cefaxone




Primary Outcome Measures :
  1. number of patients with clearence of infection [ Time Frame: 5 days ]
    number of patients having clearence of infection



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Liver cirrhosis with ascites and SBP

Exclusion Criteria:

  • ascitic fluid with polymicrobial infections

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02443285


Contacts
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Contact: Sherief M Abd-elsalam 00201095159522 Sheriefabdelsalam@yahoo.com
Contact: Sherief M Abd-elsalam, lecturer 01095159522 Sheriefabdelsalam@yahoo.com

Locations
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Egypt
Tanta university - faculty of medicine Recruiting
Cairo, Egypt
Contact: Sherief M Abdelsalam, lecturer    00201095159522    Sheriefabdelsalam@yahoo.com   
Sponsors and Collaborators
Tanta University
Investigators
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Principal Investigator: Sherief M Abd-elsalam, lecturer hepatology dept-Tanta
Study Director: Hanan H Soliman, Professor hepatology dept-Tanta
Study Chair: Walaa A Elkhalawany, lecturer hepatology dept-Tanta

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Responsible Party: Sherief Abd-Elsalam, PI, Tanta University
ClinicalTrials.gov Identifier: NCT02443285    
Other Study ID Numbers: SBP TREATMENT
First Posted: May 13, 2015    Key Record Dates
Last Update Posted: June 20, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Peritonitis
Intraabdominal Infections
Infection
Peritoneal Diseases
Digestive System Diseases
Ceftriaxone
Cephalosporins
Cefotaxime
Cefoxitin
Anti-Bacterial Agents
Anti-Infective Agents