Mucorales PCR Screening in At-risk Hematology Patients

NCT05925660 | Unknown

• 3 other identifiers: S67347IN-EU-131-6808S-number CTC UZ Leuven
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Mucormycosis

Keywords

Invasive Mycosis; Neutropenia; Leukemia; Stem Cell Transplant Complications; Invasive Mucormycosis

Outcome Measures

Primary Outcomes (1)

• Incidence of a positive Mucorales PCR screening test

  3 months

Secondary Outcomes (6)

• 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

Interventions

Mucorales PCR (MucorGenius, PathoNostics, Maastricht, The Netherlands) DIAGNOSTIC_TEST

Mucorales PCR screening twice weekly during hospitalisation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• AZ Sint-Jan AV: collaborator

Study Sites (1)

University Hospitals Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Mucormycosis; Invasive Fungal Infections; Neutropenia; Leukemia

Condition Hierarchy (Ancestors)

Zygomycosis; Mycoses; Bacterial Infections and Mycoses; Infections; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Robina Aerts, MD

CONTACT

+32 16 34 48 77; robina.aerts@kuleuven.be

Johan Maertens, MD, PhD

CONTACT

+32 16 34 66 70; johan.maertens@uzleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: June 29, 2023
• Study Start: November 6, 2023
• Primary Completion: May 31, 2024
• Study Completion: June 30, 2024
• Last Updated: December 5, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)