Clinical trial NCT05925660: Mucorales PCR Screening in At-risk Hematology Patients
Official title: Mucorales PCR Screening in At-risk Hematology Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mucormycosis
Keywords: Invasive Mycosis
Neutropenia
Leukemia
Stem Cell Transplant Complications
Invasive Mucormycosis
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: AZ Sint-Jan AV
First posted: 2023-06-29
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Primary outcomes:
measure: Incidence of a positive Mucorales PCR screening test
timeFrame: 3 months
Secondary outcomes:
measure: Incidence of invasive mucormycosis
timeFrame: 3 months
measure: Incidence of invasive aspergillosis and invasive mucormycosis coinfections
timeFrame: 3 months
measure: Number of days antifungal therapy was given (amphotericin B, azoles)
timeFrame: 3 months
measure: Was antifungal therapy started based on Mucorales PCR result? Y/N
timeFrame: 3 months
measure: Was antifungal therapy stopped based on Mucorales PCR result? Y/N
timeFrame: 3 months
measure: Outcome of patients with a positive Mucorales PCR versus these without: death or survival at 3 months
timeFrame: 3 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
state: Vlaams-Brabant
Study officials:
References: