NCT02845934

Brief Summary

This Study evaluates the performance (sensitivity, specificity, positive and negative predictive value values and likelihood ratios) of the DNA detection test for the diagnosis of mucormycosis by comparing it to the routine tests such as CT scan aspects, histopathology, microscopy and fungal culture, in a test group of 52 patients including :

  • patients at high-risk according to the EORTC/MSG criteria (patients with prolonged severe neutropenia, receiving corticosteroids or T-cell suppressors, recipients of allogeneic HSCT, or inherited severe immunodeficiency),
  • patients with other predisposing factors of invasive mould disease ( diabetes, AIDS, haematological malignancies or solid tumours, trauma, burns); Patients already diagnosed with probable or proven mucormycosis irrespective of underlying conditions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
248

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

10 active sites

Status
completed

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

Study Start

First participant enrolled

January 1, 2014

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

July 20, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 27, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

March 11, 2021

Status Verified

October 1, 2017

Enrollment Period

3.5 years

First QC Date

July 20, 2016

Last Update Submit

March 10, 2021

Conditions

Mucormycosis

Outcome Measures

Primary Outcomes (1)

  • test performance

    sensitivity, specificity, positive and negative predictive values and likelihood ratios of the DNA serum detection test will be calculated in probable and proven mucormycosis.

    8 weeks

Study Arms (1)

Mucormycosis

EXPERIMENTAL

blood sample

Other: blood sample

Interventions

blood sampleOTHER

additional sampling of blood (estimated volume 6 mL for each sampling) on day of suspicion of the mucormycosis and then twice a week up to a maximum of 8 weeks.

Mucormycosis

Eligibility Criteria

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

You may qualify if:

  • Suspicion of invasive mould infection
  • in a patient at high risk according to the EORTC/MSG criteria updated in 2008 (patients with prolonged severe neutropenia, receiving corticosteroids or T-cell suppressor, recipients of allogeneic HSCT, or inherited severe immunodeficiency)
  • or in a patient with other predisposing factors of invasive mould disease ( diabetes, AIDS, haematological malignancies or solid tumours, trauma, burns).
  • Patients already diagnosed with probable or proven mucormycosis irrespective of underlying conditions, including patients referred from other centers.
  • Only adult patients (18 years or older) will be included

You may not qualify if:

  • Age : under 18 years
  • Presence of any medical condition that would not allow collection of blood samples for the qPCR test.
  • History of documented, successfully treated, prior mucormycosis.
  • protected people (pregnant women, minor, guardianship…)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Centre Hospitalier Universitaire

Amiens, France

Location

Centre Hospitalier Régional Universitaire

Besançon, 25030, France

Location

AP-HP_Henri-Mondor

Créteil, France

Location

CHU

Dijon, France

Location

HCL

Lyon, France

Location

CHRU

Nancy, France

Location

CHU

Nantes, France

Location

AP-HP_ Necker

Paris, France

Location

AP-HP_St-Louis

Paris, France

Location

CHU

Strasbourg, France

Location

MeSH Terms

Conditions

Mucormycosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

ZygomycosisMycosesBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2016

First Posted

July 27, 2016

Study Start

January 1, 2014

Primary Completion

July 1, 2017

Study Completion

January 1, 2018

Last Updated

March 11, 2021

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(10)