Mucorales PCR Screening in At-risk Hematology Patients (MUCOPS)

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 Overview

• Status: Recruiting
• Conditions: Mucormycosis
• Intervention / Treatment: Diagnostic test: Mucorales PCR (MucorGenius, PathoNostics, Maastricht, The Netherlands)

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Robina Aerts, MD; Phone Number: +32 16 34 48 77; Email: robina.aerts@kuleuven.be
• Study Contact Backup: Name: Johan Maertens, MD, PhD; Phone Number: +32 16 34 66 70; Email: johan.maertens@uzleuven.be

Study Locations

• Belgium
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • Recruiting
      • University Hospitals Leuven
      • Contact: Robina Aerts, MD; Phone Number: +3216344877; Email: robina.aerts@kuleuven.be
      • Contact: Yuri Vanbiervliet, MD; Email: yuri.vanbiervliet@uzleuven.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of a positive Mucorales PCR screening test	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Collaborators: AZ Sint-Jan AV

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2023
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: June 15, 2023
• First Submitted That Met QC Criteria: June 26, 2023
• First Posted (Actual): June 29, 2023

Study Record Updates

• Last Update Posted (Estimated): December 5, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Leukemia; Invasive Mycosis; Neutropenia; Stem Cell Transplant Complications; Invasive Mucormycosis
• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Mycoses; Mucormycosis; Zygomycosis
• Other Study ID Numbers: S67347; IN-EU-131-6808 (Other Grant/Funding Number: Gilead Sciences); S-number CTC UZ Leuven (Other Identifier: S67347)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No