Prospective Evaluation of a New Molecular Tool for Early Diagnosis of Mucormycosis

Mucormycosis Clinical Trial

— MODIMUCOR  

Official title:

Prospective Evaluation of a New Molecular Tool for Early Diagnosis of Mucormycosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02845934
• Other study ID #: N/2013/65
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: January 2018

Study information

• Verified date: October 2017
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The patients eligible for this study will already be hospitalized with repeated monitoring of clinical and biological parameters.

Participation in the study will result in an 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.

vials will be added to the routine sampling of these patients (ie, at the time of routine sampling for galactomannan antigemia), and no new sampling procedure will be required.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 248
• Est. completion date: January 2018
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Age : under 18 years

• Patients previously included in the trial with a diagnosis of mucormycosis. However patients previously entered in the trial with a diagnosis other than mucormycosis will be eligible for re- new inclusion.

• 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…)

Related Conditions & MeSH terms

• Mucormycosis
• Zygomycosis

Intervention

Other:
• blood sample
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.

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire	Amiens
France	Centre Hospitalier Régional Universitaire	Besançon
France	AP-HP_Henri-Mondor	Créteil
France	CHU	Dijon
France	HCL	Lyon
France	CHRU	Nancy
France	CHU	Nantes
France	AP-HP_ Necker	Paris
France	AP-HP_St-Louis	Paris
France	CHU	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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