NCT06679842

Brief Summary

Paracentesis at 48 hours, as recommended in international guidelines, could delay the time to effective antibiotic therapy in cases of SBP with germs resistant to empirical antibiotic therapy. Earlier paracentesis at 24 hours could save time in initiating the right antibiotic therapy and improve prognosis.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2024

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 8, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

November 11, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

November 8, 2024

Status Verified

November 1, 2024

Enrollment Period

1.4 years

First QC Date

November 6, 2024

Last Update Submit

November 6, 2024

Conditions

CirrhosisSpontaneous Bacterial Peritonitis

Keywords

resistant bacteriaspontaneous bacterial peritonitisantibioticearly paracentesis

Outcome Measures

Primary Outcomes (1)

  • Evaluate the percentage drop in neutrophils in ascites on Day 1

    Evaluate the percentage drop in neutrophils in ascites on Day 1, in order to assess the best threshold for predicting response to antibiotic therapy on Day 1 (judged on Day 2) in patients with ascites fluid infection.

    24 hours

Study Arms (1)

one arm

EXPERIMENTAL
Diagnostic Test: ascitis paracentesis

Interventions

ascitis paracentesisDIAGNOSTIC_TEST

ascitis paracentesis

one arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women aged 18 or over
  • Affiliation with a French social security
  • Signature of the informed consent form
  • Cirrhosis
  • Ascites fluid infection with PNN \> 250/mm3

You may not qualify if:

  • Pregnant women
  • Persons deprived of their liberty by judicial or administrative decision; persons under psychiatric care.
  • Adults under legal protection
  • Other cause of abdominal infection than SBP
  • Intra-abdominal surgery \< 4 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hepatology Unit, CHU Besancon

Besançon, Doubs, 25000, France

Location

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Jean Paul CERVONI, Hospital Practioner

CONTACT

+33 3 81 66 80 20jpcervoni@chu-besancon.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2024

First Posted

November 8, 2024

Study Start

November 11, 2024

Primary Completion

March 31, 2026

Study Completion

April 30, 2026

Last Updated

November 8, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)