Evaluation of the Strip PeriScreen for the Fast Diagnosis of the Spontaneous Infection of the Liquid of Ascites During the Cirrhosis

Infection Clinical Trial

— Per-DRISLA  

Official title:

Evaluation of the Strip PeriScreen for the Fast Diagnosis of the Spontaneous Infection of the Liquid of Ascites During the Cirrhosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02085915
• Other study ID #: CHD 065-13
• Status: Completed
• Phase: N/A
• First received: March 7, 2014
• Last updated: September 15, 2015
• Start date: March 2014
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: Centre Hospitalier Departemental Vendee
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéFrance: The Commission nationale de l’informatique et des libertés
• Study type: Interventional

Clinical Trial Summary

The forecast of the spontaneous infection of the liquid of ascites (ISLA) at the cirrhotic patient is still burdened by a heavy mortality. The fast diagnosis of the ISLA is thus an essential stake to improve the forecast.

Investigators would so like to estimate the interest of the strip PeriScreen for the fast diagnosis of the ISLA at cirrhotic patients . Investigators plan to include 670 patients, what would allow to make out a will at least on ascites 2000 on about twenty centers for duration estimated of 12 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 670
• Est. completion date: September 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female over 18 years

• Presence of ascites due to cirrhosis

• Hospitalization for a complication of cirrhosis (ascites first decompensation, gastrointestinal bleeding, encephalopathy, etc ...).

or

• Hospitalization to perform a paracentesis evacuated outpatient

• Patients on long-term antibiotic primary or secondary prophylaxis the spontaneous bacterial peritonitis and with clinical and/or biological signs that suggest spontaneous infection of ascite.

Exclusion Criteria:

• Patients with ascites urgently admitted to hospital for suspected infection receiving antibiotics for more than 12 hours.

• chylous ascites,

• Hemorrhagic Ascites

• Biliary Ascites (straw)

• Ascites heterogeneous appearance

• Ascites not related to portal hypertension (peritoneal carcinomatosis, pancreatic ascites, tuberculosis, etc ...)

• Patient receiving imipenem IV.

• Patients on long-term antibiotic primary or secondary prophylaxis the spontaneous bacterial peritonitis without clinical and/or biological signs that suggest spontaneous infection of ascite.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Ascites
• Cirrhosis
• Infection
• Liquid of Ascites
• Liver Cirrhosis

Intervention

Other:
• strip Peri Screen

Locations

Country	Name	City	State
Belgium	Hopital Jolimont	Haine-Saint-Paul
France	CH Amiens	Amiens
France	CHU Besançon	Besançon
France	CHRU de Brest	Brest
France	CH Caen	Caen
France	CH Cholet	Cholet
France	Hopîtal Beaujon	Clichy
France	Hopital Laennec	Creil
France	CH Dijon	Dijon
France	CH Gonesse	Gonesse
France	CHD Vendée	La Roche sur Yon
France	CH Lille	Lille
France	CHU Nice	Nice
France	CH Orléans	Orléans
France	CH Reims	Reims
France	CH Rennes	Rennes
France	CH Rouen	Rouen
France	CH St Antoine	Saint Antoine
France	CH Yves Le Foll	Saint-Brieuc
France	CH Saint-Denis - Hôpital de la Fontaine	Saint-Denis
France	Hôpital Purpan	Toulouse
France	CH Vannes	Vannes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Departemental Vendee

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	liquid of ascites spontaneous infection	Periscreen strip compared to the cytological analysis	Baseline	No