MucormycosisMUCOPSNCT05925660
Mucorales PCR Screening in At-risk Hematology Patients
A study testing Mucorales PCR (MucorGenius, PathoNostics, Maastricht, The Netherlands) in people with Mucormycosis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Patients with leukemia are treated with intensive chemotherapy and often have to undergo a stem cell transplantation which makes their immune system extremely vulnerable. This puts them at risk for invasive fungal infections, of which invasive mucormycosis (IM) is one of the most dangerous ones. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mucormycosis
- What is being tested?
- Mucorales PCR (MucorGenius, PathoNostics, Maastricht, The Netherlands)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteBelgium
- Study dates
- 6 Nov 2023to 27 Jun 2026
- 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
- Underlying disease:
- Start of remission induction chemotherapy for acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) that is newly diagnosed or in first relapse after hematological remission lasting for a minimum duration of 6 months; OR
- Start of myeloablative conditioning regimen to prepare for a first allogeneic hematopoietic cell transplantation (HCT).
- Expected prolonged neutropenia (ANC< 0.5 x 109 /L for ≥ 7 days).
- Planned hospital admission for the duration of the neutropenic phase.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Patients with leukemia are treated with intensive chemotherapy and often have to undergo a stem cell transplantation which makes their immune system extremely vulnerable. This puts them at risk for invasive fungal infections, of which invasive mucormycosis (IM) is one of the most dangerous ones. Treatment of IM is complex and mortality rates are still extremely high, ranging from 40% to 80% and sometimes even higher if the central nervous system is involved. Mucormycosis requires immediate intervention due to the rapidly progressive and destructive nature of the infection. But the diagnosis is often made too late…
Better survival can be achieved with a faster diagnosis. A new test has recently been developed for detection of Mucorales DNA by PCR. The polymerase chain reaction (PCR) is a method that allows to quickly make millions of copies of, for example, Mucorales DNA in order to detect it in the blood at an early stage. Because blood can easily be obtained, without an additional burden on the patient, the test could be interesting for screening for these infections, which then offers the opportunity to start an adequate treatment more quickly.
However, the test is now only performed if there is a clinical suspicion of IM. But at that point, precious time has already been lost, and often the patient can no longer be cured. In this study the utility of the Mucorales PCR as a possible screening test in at-risk patients is assessed. The participants, hospitalised patients with leukemia, will be screened twice weekly with a Mucorales PCR test during their most vulnerable period. If the study shows that the test helps in diagnosing IM faster, this could have an important impact on the treatment and survival of these at-risk patients.
- Conditions
- Mucormycosis
- Being tested
- Mucorales PCR (MucorGenius, PathoNostics, Maastricht, The Netherlands)
- Keywords
- Invasive Mycosis, Neutropenia, Leukemia, Stem Cell Transplant Complications, Invasive Mucormycosis
- Medical subject headings
- Mucormycosis, Invasive Fungal Infections, Neutropenia, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mucorales PCR (MucorGenius, PathoNostics, Maastricht, The Netherlands)Diagnostic test
Mucorales PCR screening twice weekly during hospitalisation
| Study group | Role | What they receive |
|---|---|---|
| single-arm study | Experimental | plasma Mucorales PCR screening twice weekly Receives: Diagnostic Test: Mucorales PCR (MucorGenius, PathoNostics, Maastricht, The Netherlands) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of a positive Mucorales PCR screening test
Measured: 3 months
Secondary outcomes (6)
Incidence of invasive mucormycosis
Measured: 3 months
Incidence of invasive aspergillosis and invasive mucormycosis coinfections
Measured: 3 months
Number of days antifungal therapy was given (amphotericin B, azoles)
Measured: 3 months
Was antifungal therapy started based on Mucorales PCR result? Y/N
Measured: 3 months
Was antifungal therapy stopped based on Mucorales PCR result? Y/N
Measured: 3 months
Outcome of patients with a positive Mucorales PCR versus these without: death or survival at 3 months
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start6 Nov 2023
- Primary completion27 Jun 2026
- Study completion27 Jun 2026
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 Universitaire Ziekenhuizen KU LeuvenThe 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- AZ Sint-Jan AV
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05925660
- Sponsor's protocol ID
- S67347
- Other IDs
- IN-EU-131-6808, S-number CTC UZ Leuven
- Acronym
- MUCOPS
- Status last verified
- Jun 2023
- First submitted
- 15 Jun 2023
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mucorales PCR Screening in At-risk Hematology Patients
- ClinicalTrials.gov ID
- NCT05925660
- Acronym / sponsor ID
- MUCOPS / S67347
- Conditions
- Mucormycosis
- Keywords
- Invasive Mycosis, Neutropenia, Leukemia, Stem Cell Transplant Complications, Invasive Mucormycosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- AZ Sint-Jan AV
- Study start
- 6 Nov 2023 (actual)
- Primary completion
- 27 Jun 2026 (actual)
- Study completion
- 27 Jun 2026 (actual)
- First posted
- 29 Jun 2023 (actual)
- 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.
Patients with leukemia are treated with intensive chemotherapy and often have to undergo a stem cell transplantation which makes their immune system extremely vulnerable. This puts them at risk for invasive fungal infections, of which invasive mucormycosis (IM) is one of the most dangerous ones. Treatment of IM is complex and mortality rates are still extremely high, ranging from 40% to 80% and sometimes even higher if the central nervous system is involved. Mucormycosis requires immediate intervention due to the rapidly progressive and destructive nature of the infection. But the diagnosis is often made too late…
Better survival can be achieved with a faster diagnosis. A new test has recently been developed for detection of Mucorales DNA by PCR. The polymerase chain reaction (PCR) is a method that allows to quickly make millions of copies of, for example, Mucorales DNA in order to detect it in the blood at an early stage. Because blood can easily be obtained, without an additional burden on the patient, the test could be interesting for screening for these infections, which then offers the opportunity to start an adequate treatment more quickly.
However, the test is now only performed if there is a clinical suspicion of IM. But at that point, precious time has already been lost, and often the patient can no longer be cured. In this study the utility of the Mucorales PCR as a possible screening test in at-risk patients is assessed. The participants, hospitalised patients with leukemia, will be screened twice weekly with a Mucorales PCR test during their most vulnerable period. If the study shows that the test helps in diagnosing IM faster, this could have an important impact on the treatment and survival of these at-risk patients.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single-arm study | Experimental | Diagnostic Test: Mucorales PCR (MucorGenius, PathoNostics, Maastricht, The Netherlands)plasma Mucorales PCR screening twice weekly |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Underlying disease:
- Expected prolonged neutropenia (ANC< 0.5 x 109 /L for ≥ 7 days).
- Planned hospital admission for the duration of the neutropenic phase.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Mucorales PCR (MucorGenius, PathoNostics, Maastricht, The Netherlands)Mucorales PCR screening twice weekly during hospitalisation | Diagnostic test | single-arm study |
Primary outcome
Incidence of a positive Mucorales PCR screening test
Time frame: 3 months
6 secondary outcomes
Incidence of invasive mucormycosis
Time frame: 3 months
Incidence of invasive aspergillosis and invasive mucormycosis coinfections
Time frame: 3 months
Number of days antifungal therapy was given (amphotericin B, azoles)
Time frame: 3 months
Was antifungal therapy started based on Mucorales PCR result? Y/N
Time frame: 3 months
Was antifungal therapy stopped based on Mucorales PCR result? Y/N
Time frame: 3 months
Outcome of patients with a positive Mucorales PCR versus these without: death or survival at 3 months
Time frame: 3 months
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 23 Oct 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mucorales PCR (MucorGenius, PathoNostics, Maastricht, The Netherlands) in people with Mucormycosis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 0 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 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
Incidence of a positive Mucorales PCR screening test (time frame: 3 months). 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 23 Oct 2026.