Diagnosis of Spontaneous Bacterial Peritonitis

Spontaneous Bacterial Peritonitis Clinical Trial

— ARSDIASP  

Official title:

Redefinition of Diagnostic Criteria for Spontaneous Bacterial Peritonitis: Assessment of Accuracy of Available Tests and of Reference Standard

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01598870
• Other study ID #: AOLecco001
• Status: Recruiting
• Phase: N/A
• First received: May 11, 2012
• Last updated: January 13, 2015
• Start date: May 2012
• Est. completion date: October 2015

Study information

• Verified date: January 2015
• Source: Azienda Ospedaliera di Lecco
• Contact: Agostino Colli, MD
• Phone: +390341489670
• Email: a.colli[@]ospedale.lecco.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial Summary

The study is aimed to revise the current criteria for the diagnosis of spontaneous bacterial peritonitis and the decisional thresholds to start treatment. The accuracy of current diagnostic tests will be compared with that of new tests, which could potentially become more accurate reference standards. This could lead to the definition of a more accurate and effective diagnostic algorithm.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with cirrhosis and ascites with clinical indication to carry out a diagnostic and/or therapeutic paracentesis.

Exclusion Criteria:

• Etiology of ascites other than cirrhosis

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Peritonitis
• Spontaneous Bacterial Peritonitis

Intervention

Other:
• Diagnostic tests
Leukocyte count by automated counters; reagent strips for leukocyte esterase and for lactoferrin; ascitic fluid pH; leukocyte cytometry; bacterial DNA detection and quantification.

Locations

Country	Name	City	State
Italy	Department of Medicine, A. Manzoni Hospital	Lecco

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera di Lecco

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparing the accuracy of current reference standard for the diagnosis of spontaneous bacterial peritonitis, i.e. neutrophil count in ascitic fluid of >250/mm3 as determined by microscopy, with alternative diagnostic tests.	Reference standard is neutrophil count in ascitic fluid of >250/mm3 as determined by microscopy.; Alternative diagnostic tests are: Leukocyte count by automated counters; reagent strips for leukocyte esterase and for lactoferrin; ascitic fluid pH; leukocyte cytometry; bacterial DNA detection and quantification.; Discrepancies between reference standard and alternative tests will be assessed by one month clinical follow up.	One month	No