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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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

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.

Belgium1 site
  • University Hospitals Leuven

    Leuven, Vlaams-Brabant, 3000

Other trials in Belgium

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 groups in NCT05925660
Study groupRoleWhat they receive
single-arm studyExperimentalplasma 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.

  1. Incidence of a positive Mucorales PCR screening test

    Measured: 3 months

Secondary outcomes (6)
  1. Incidence of invasive mucormycosis

    Measured: 3 months

  2. Incidence of invasive aspergillosis and invasive mucormycosis coinfections

    Measured: 3 months

  3. Number of days antifungal therapy was given (amphotericin B, azoles)

    Measured: 3 months

  4. Was antifungal therapy started based on Mucorales PCR result? Y/N

    Measured: 3 months

  5. Was antifungal therapy stopped based on Mucorales PCR result? Y/N

    Measured: 3 months

  6. 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.

  1. First posted29 Jun 2023
  2. Study start6 Nov 2023
  3. Primary completion27 Jun 2026
  4. Study completion27 Jun 2026

Resources

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)
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

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