Mucorales PCR Screening in At-risk Hematology Patients

Mucormycosis Clinical Trial

— MUCOPS  

Official title:

Mucorales PCR Screening in At-risk Hematology Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05925660
• Other study ID #: S67347
• Secondary ID: IN-EU-131-6808S-
• Status: Recruiting
• Phase: N/A
• Start date: November 6, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: June 2023
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: Robina Aerts, MD
• Phone: +32 16 34 48 77
• Email: robina.aerts[@]kuleuven.be
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 30, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mucormycosis
• Zygomycosis

Intervention

Diagnostic Test:
• Mucorales PCR (MucorGenius, PathoNostics, Maastricht, The Netherlands)
Mucorales PCR screening twice weekly during hospitalisation

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven	Vlaams-Brabant

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven	AZ Sint-Jan AV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of a positive Mucorales PCR screening test		3 months
Secondary	Incidence of invasive mucormycosis		3 months
Secondary	Incidence of invasive aspergillosis and invasive mucormycosis coinfections		3 months
Secondary	Number of days antifungal therapy was given (amphotericin B, azoles)		3 months
Secondary	Was antifungal therapy started based on Mucorales PCR result? Y/N		3 months
Secondary	Was antifungal therapy stopped based on Mucorales PCR result? Y/N		3 months
Secondary	Outcome of patients with a positive Mucorales PCR versus these without: death or survival at 3 months		3 months