NCT03674359

Brief Summary

Systematic and repeated dosing (3 times weekly) of 1,3-β-D-glucan (BDG), associated with blood cultures and fungal mapping (twice a week) for the patients hospitalized in intensive care. The diagnosis of candidemia is defined as the 1st positive blood culture for Candida spp. The dosage of BDG will be considered positive if the value is at least or equal to 80 pg/ml.

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
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2018

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

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

September 10, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 17, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

December 12, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

January 26, 2021

Status Verified

December 1, 2020

Enrollment Period

2.7 years

First QC Date

September 10, 2018

Last Update Submit

January 24, 2021

Conditions

Infection, Fungal

Keywords

1, 3-β-D-glucan, Candidemia, Intensive Care Unit

Outcome Measures

Primary Outcomes (1)

  • Determine the sensitivity and specificity of the BDG for the diagnosis of candidemia in intensive care unit patients.

    Systematic and repeated dosing , for the diagnosis of candidemia (1st positive blood culture for Candida spp). Dosage of BDG will be considered positive if a dosage is at least equal to 80 pg/ml or greater.

    30 day after inclusion

Study Arms (1)

Cohort

Patients hospitalized in intensive care, meeting the inclusion criteria. BDG analysis

Diagnostic Test: BDG analysis

Interventions

BDG analysisDIAGNOSTIC_TEST

BDG analysis

Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients aged over 18, hospitalized in intensive care unit, under mechanical ventilation, antibiotics and with a central venous catheter, excluding pregnant or breastfeeding women.

You may qualify if:

  • Patients ≥ 18 years
  • Patients Under mechanical ventilation (MV), antibiotic (AB) And with a central venous catheter (CVK)
  • Affiliation to the social security system.
  • Signed informed consent

You may not qualify if:

  • Antifungal therapy at the admission in intensive care unit
  • Patient being treated for Pneumocystis carinii pneumonia (PCP)
  • Pregnant or breastfeeding woman
  • Neutropenia: \< 500 nuclear neutrophil / mm3
  • Patients under ECMO

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hopital Avicenne

Bobigny, 93000, France

RECRUITING

Hôpital Louis Mourier

Colombes, 92701, France

RECRUITING

Related Publications (4)

  • Lortholary O, Renaudat C, Sitbon K, Madec Y, Denoeud-Ndam L, Wolff M, Fontanet A, Bretagne S, Dromer F; French Mycosis Study Group. Worrisome trends in incidence and mortality of candidemia in intensive care units (Paris area, 2002-2010). Intensive Care Med. 2014 Sep;40(9):1303-12. doi: 10.1007/s00134-014-3408-3. Epub 2014 Aug 6.

    PMID: 25097069RESULT

  • Clancy CJ, Nguyen MH. Finding the "missing 50%" of invasive candidiasis: how nonculture diagnostics will improve understanding of disease spectrum and transform patient care. Clin Infect Dis. 2013 May;56(9):1284-92. doi: 10.1093/cid/cit006. Epub 2013 Jan 11.

    PMID: 23315320RESULT

  • Morrell M, Fraser VJ, Kollef MH. Delaying the empiric treatment of candida bloodstream infection until positive blood culture results are obtained: a potential risk factor for hospital mortality. Antimicrob Agents Chemother. 2005 Sep;49(9):3640-5. doi: 10.1128/AAC.49.9.3640-3645.2005.

    PMID: 16127033RESULT

  • Posteraro B, De Pascale G, Tumbarello M, Torelli R, Pennisi MA, Bello G, Maviglia R, Fadda G, Sanguinetti M, Antonelli M. Early diagnosis of candidemia in intensive care unit patients with sepsis: a prospective comparison of (1-->3)-beta-D-glucan assay, Candida score, and colonization index. Crit Care. 2011;15(5):R249. doi: 10.1186/cc10507. Epub 2011 Oct 22.

    PMID: 22018278RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample, plasma for dosage of 1, 3-β-D-glucan

MeSH Terms

Conditions

MycosesCandidemia

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfectionsCandidiasis, InvasiveCandidiasisInvasive Fungal InfectionsFungemiaSepsisSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Philippe KAROUBI, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe KAROUBI, MD

CONTACT

+33 1 48 95 21 96philippe.karoubi@aphp.fr

Mohammed RAHAOUI, PM

CONTACT

+33 1 48 95 74 71mohammed.rahaoui@aphp.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2018

First Posted

September 17, 2018

Study Start

December 12, 2018

Primary Completion

September 1, 2021

Study Completion

March 1, 2022

Last Updated

January 26, 2021

Record last verified: 2020-12

Locations

FR(2)