- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03140748
Kinetics of Serum β-D-glucan During Peritonitis With Candida in Resuscitation (PERIGLUC1)
September 5, 2023 updated by: Centre Hospitalier Universitaire, Amiens
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hervé DUPONT, PhD
- Phone Number: +33322668375
- Email: dupont.herve@chu-amiens.fr
Study Locations
-
-
Picardie
-
Amiens, Picardie, France, 80054
- CHU Amiens Picardie
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Patients with fungal peritonitis
|
To evaluate the initial levels and kinetics of serum β-D-glucan during fungal peritonitis compared to a control group of yeast-free peritonitis
|
Other: Patients with peritonitis without yeast
|
To evaluate the initial levels and kinetics of serum β-D-glucan during fungal peritonitis compared to a control group of yeast-free peritonitis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood determination of serum β-D-glucan kinetics in patients with peritonitis
Time Frame: 28 days
|
Blood determination of serum β-D-glucan kinetics in patients with peritonitis
|
28 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2018
Primary Completion (Actual)
August 22, 2021
Study Completion (Actual)
June 1, 2023
Study Registration Dates
First Submitted
April 14, 2017
First Submitted That Met QC Criteria
May 2, 2017
First Posted (Actual)
May 4, 2017
Study Record Updates
Last Update Posted (Actual)
September 6, 2023
Last Update Submitted That Met QC Criteria
September 5, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI2016_843_0036
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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