NCT03140748

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2017

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 4, 2017

Completed
12 months until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2021

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

3.3 years

First QC Date

April 14, 2017

Last Update Submit

September 16, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

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

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

    28 days

Study Arms (2)

Patients with fungal peritonitis

OTHER
Other: To evaluate the initial levels and kinetics of serum β-D-glucan

Patients with peritonitis without yeast

OTHER
Other: To evaluate the initial levels and kinetics of serum β-D-glucan

Interventions

To evaluate the initial levels and kinetics of serum β-D-glucan during fungal peritonitis compared to a control group of yeast-free peritonitis

Patients with fungal peritonitisPatients with peritonitis without yeast

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens Picardie

Amiens, Picardie, 80054, France

Location

Related Publications (1)

  • Dupont H, Malaquin S, Villeret L, Macq PY, Ammenouche N, Tinturier F, Diouf M, Rumbach M, Chouaki T. Is ss-d-glucan Relevant for the Diagnosis and Follow-Up of Intensive Care Patients with Yeast-Complicated Intra-Abdominal Infection? J Fungi (Basel). 2022 May 6;8(5):487. doi: 10.3390/jof8050487.

MeSH Terms

Conditions

Candidiasis

Condition Hierarchy (Ancestors)

MycosesBacterial Infections and MycosesInfections

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2017

First Posted

May 4, 2017

Study Start

May 1, 2018

Primary Completion

August 22, 2021

Study Completion

June 1, 2023

Last Updated

September 19, 2025

Record last verified: 2025-09

Locations