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

Sponsor
Centre Hospitalier Universitaire, Amiens (Other)
Overall Status
Unknown status
CT.gov ID
NCT03140748
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
25
Anticipated Duration (Months)
2.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: To evaluate the initial levels and kinetics of serum β-D-glucan
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Kinetics of Serum β-D-glucan During Peritonitis With Candida in Resuscitation
Actual Study Start Date :
May 1, 2018
Anticipated Primary Completion Date :
Jun 1, 2020
Anticipated Study Completion Date :
Jun 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Other: Patients with fungal peritonitis

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

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

Outcome Measures

Primary Outcome Measures

  1. Blood determination of serum β-D-glucan kinetics in patients with peritonitis [28 days]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Amiens Picardie Amiens Picardie France 80054

Sponsors and Collaborators

  • Centre Hospitalier Universitaire, Amiens

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier:
NCT03140748
Other Study ID Numbers:
  • PI2016_843_0036
First Posted:
May 4, 2017
Last Update Posted:
Oct 4, 2018
Last Verified:
Oct 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Peritonitis
Candidiasis

Study Results

No Results Posted as of Oct 4, 2018