MucormycosisMODIMUCORNCT02845934
Prospective Evaluation of a New Molecular Tool for Early Diagnosis of Mucormycosis
A study testing blood sample in people with Mucormycosis, run by Centre Hospitalier Universitaire de Besancon at 10 sites in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mucormycosis
- What is being tested?
- blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 10 sitesFrance
- Study dates
- Jan 2014to Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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…)
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
Centre Hospitalier Universitaire
Amiens
Centre Hospitalier Régional Universitaire
Besançon, 25030
AP-HP_Henri-Mondor
Créteil
CHU
Dijon
HCL
Lyon
CHRU
Nancy
CHU
Nantes
AP-HP_ Necker
Paris
AP-HP_St-Louis
Paris
CHU
Strasbourg
About this study
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.
Read the detailed 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.
- Conditions
- Mucormycosis
- Being tested
- blood sample
- Medical subject headings
- Mucormycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Mucormycosis | Experimental | blood sample Receives: Other: blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study startJan 2014
- Primary completionJul 2017
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MucormycosisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02845934
- Sponsor's protocol ID
- N/2013/65
- Acronym
- MODIMUCOR
- Status last verified
- Oct 2017
- First submitted
- 20 Jul 2016
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of a New Molecular Tool for Early Diagnosis of Mucormycosis
- ClinicalTrials.gov ID
- NCT02845934
- Acronym / sponsor ID
- MODIMUCOR / N/2013/65
- Conditions
- Mucormycosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 27 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mucormycosis | Experimental | Other: blood sampleblood sample |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Suspicion of invasive mould infection
- 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
Key exclusion criteria (5 listed)
- 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…)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood sampleadditional 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. | Other | Mucormycosis |
Primary outcome
test performance
Time frame: 8 weeks
sensitivity, specificity, positive and negative predictive values and likelihood ratios of the DNA serum detection test will be calculated in probable and proven mucormycosis.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sample in people with Mucormycosis, run by Centre Hospitalier Universitaire de Besancon at 10 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
test performance (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2021.