MUCOPS: Mucorales PCR Screening in At-risk Hematology Patients

Sponsor

Universitaire Ziekenhuizen KU Leuven (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05925660

Collaborator

AZ Sint-Jan AV (Other)

Enrollment

10.7

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mucormycosis	Diagnostic Test: Mucorales PCR (MucorGenius, PathoNostics, Maastricht, The Netherlands)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

Mucorales PCR Screening in At-risk Hematology Patients

Anticipated Study Start Date :

Aug 10, 2023

Anticipated Primary Completion Date :

May 31, 2024

Anticipated Study Completion Date :

Jun 30, 2024

Outcome Measures

Primary Outcome Measures

Incidence of a positive Mucorales PCR screening test [3 months]

Secondary Outcome Measures

Incidence of invasive mucormycosis [3 months]
Incidence of invasive aspergillosis and invasive mucormycosis coinfections [3 months]
Number of days antifungal therapy was given (amphotericin B, azoles) [3 months]
Was antifungal therapy started based on Mucorales PCR result? Y/N [3 months]
Was antifungal therapy stopped based on Mucorales PCR result? Y/N [3 months]
Outcome of patients with a positive Mucorales PCR versus these without: death or survival at 3 months [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.