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Kinetics of Serum β-D-glucan During Peritonitis With Candida in Resuscitation (PERIGLUC1)

Primary Purpose

Peritonitis Infectious, Candida Infection

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
To evaluate the initial levels and kinetics of serum β-D-glucan
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Peritonitis Infectious

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Major Patient (age ≥ 18 years)
  • Community or associated peritonitis, operated and hospitalized in resuscitation
  • Affiliation to a social security scheme

Exclusion Criteria:

  • Allergy known to echinocandins
  • Dying Patient
  • Limitation of care
  • Predictable duration of follow-up ≤ 10 days
  • Transfusion within 3 months
  • Patient minor, patient under guardianship or curatorship

Sites / Locations

  • CHU Amiens Picardie

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Patients with fungal peritonitis

Patients with peritonitis without yeast

Arm Description

Outcomes

Primary Outcome Measures

Blood determination of serum β-D-glucan kinetics in patients with peritonitis
Blood determination of serum β-D-glucan kinetics in patients with peritonitis

Secondary Outcome Measures

Full Information

First Posted
April 14, 2017
Last Updated
September 5, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT03140748
Brief Title
Kinetics of Serum β-D-glucan During Peritonitis With Candida in Resuscitation
Acronym
PERIGLUC1
Official Title
Kinetics of Serum β-D-glucan During Peritonitis With Candida in Resuscitation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
August 22, 2021 (Actual)
Study Completion Date
June 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Intraabdominal fungal infections with Candida are constantly increasing. Their diagnosis and treatment is difficult. Morbidity and mortality are high. Β-D-Glucan has been proposed as a marker of systemic fungal infection in candidemia. Moreover, its kinetics is associated with therapeutic success. On the other hand, there are no data on intraabdominal infections that are much more frequent. The objective of the study is to evaluate the initial levels of β-D-glucan and its daily kinetics during the treatment of fungal peritonitis in resuscitation compared to a control group with a yeast-free peritonitis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peritonitis Infectious, Candida Infection

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with fungal peritonitis
Arm Type
Other
Arm Title
Patients with peritonitis without yeast
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
To evaluate the initial levels and kinetics of serum β-D-glucan
Intervention Description
To evaluate the initial levels and kinetics of serum β-D-glucan during fungal peritonitis compared to a control group of yeast-free peritonitis
Primary Outcome Measure Information:
Title
Blood determination of serum β-D-glucan kinetics in patients with peritonitis
Description
Blood determination of serum β-D-glucan kinetics in patients with peritonitis
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Major Patient (age ≥ 18 years) Community or associated peritonitis, operated and hospitalized in resuscitation Affiliation to a social security scheme Exclusion Criteria: Allergy known to echinocandins Dying Patient Limitation of care Predictable duration of follow-up ≤ 10 days Transfusion within 3 months Patient minor, patient under guardianship or curatorship
Facility Information:
Facility Name
CHU Amiens Picardie
City
Amiens
State/Province
Picardie
ZIP/Postal Code
80054
Country
France

12. IPD Sharing Statement

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Kinetics of Serum β-D-glucan During Peritonitis With Candida in Resuscitation

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