Revision of Antifungal Strategies Definitions for Invasive Fungal Infections in Hematological Malignancies

NCT04024995 | Completed

• 1 other identifier: REDEFI-SEIFEM
• Study Type: observational
• Target: 513
• Locations: 1 country
• Sites: 14

Brief Summary

The primary objective of this study is to evaluate invasive fungal infections (IFI) according to clinicians' opinion vs the opinion of an independent board of experts. The primary output of this study is the evaluation of inter-raters agreement. Secondary objectives are: evaluation of IFI incidence; description of clinical and laboratory features; frequencies of different antifungal treatments; description of outcome; impact on the treatment of underlying hematological malignancy. This is a multicenter, non-interventional observational, prospective study. The duration of the study will be 18 months. The study will recruit all consecutive eligible patients in each participating center, during a period of 6 months until at least 600 patients with acute myeloid leukemia are registered, that represented the highest risk category. Other disease types that fulfill the eligibility criteria in the participating centers during the same period will also be recruited in the study. The clinical, microbiological, diagnostic and therapeutic procedures operated on these patients will be collected. An eCRF will be compiled for all patients: T0: at the start of antifungal treatment, information will be collected regarding hematological malignancy, status of the disease at onset of infection and phase of treatment, last chemotherapy regimen, comorbidities and risk factors; previous IFI, neutropenia, antifungal and antibiotic prophylaxis and the kind of IFI clinicians retain the patient suffer (possible/probable/proven) and the kind of antifungal treatment started (empiric/pre-emptive/target); diagnostic work-up done, positive microbiology and biomarkers, positive radiological findings; antifungal treatment. T1: at 30-40 days (or before if the patient unfortunately died) a second form must be completed with information regarding any changes in/additional diagnostic work-up done, positive microbiology and biomarkers, positive radiological findings; any changes in antifungal treatment; outcome. At that time, the local physician must state any revision of his diagnostic classification between the moment in which antifungal treatment was started and the moment of evaluation of the outcome in order to estimate the differences regarding the level of evidence of diagnosis and treatment of IFI during time. Each case will be examined blinded by 2 different experts, who will review all records based on the existing guidelines, their own experience and the information that was known at the two time points, which may confirm or not the decision of local physician. The sample size will be driven by the AML patients (approximately 60-70% of the patients). Sample will be described in its clinical and demographic features via descriptive statistics. Quantitative variables will be summarized with the following measures: minimum, maximum, range, mean and standard deviation. Qualitative variables will be represented by frequencies tables.

Conditions

Invasive Fungal Infections

Keywords

Invasive Fungal Infections; EORTC/MSG criteria

Outcome Measures

Primary Outcomes (1)

• Rate of diagnosis Agreement in proven/probable/possible IFI in real life using EORTC/MSG Criteria

  Rate of diagnosis agreement in proven/probable/possible IFI between local physician in real life and indipendent board of experts according to EORTC/MSG Criteria

  30 days

Secondary Outcomes (2)

• Evaluation of incidence of invasive fungal infections

  6 months

• Attributable and all-cause mortality of patients with invasive fungal infections

  30 days

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will recruit all consecutive eligible patients in each participating center, during a period of 6 months until at least 600 AML patients are registered, that represented the highest risk category of patients for IFI. Other disease types that fulfill the eligibility criteria in the participating centers during the same period will also be recruited in the study.

You may qualify if:

• All patients with hematologic malignancies at any stage of the disease (acute myeloid leukemia, acute lymphoblastic leukemia, multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia, high and low grade non Hodgkin lymphoma, chronic myeloprolipherative disorders, Hodgkin lymphoma);
• Only inpatients will be eligible;
• Patient that start IV antifungal treatment (irrespective of previous prophylaxis);
• Informed consent signed.

You may not qualify if:

• Patients with previous or undergoing allogeneic or autologous transplant will be excluded from the study, due to different clinical profiles and risk factors;
• Patients treated, after prophylaxis with oral antifungals
• Patients treated in outpatient clinic or Day hospital

Sponsors & Collaborators

• Sorveglianza Epidemiologica Infezioni Fungine Emopatie Maligne: lead

Study Sites (14)

Azienda Ospedaliera Universitaria S. Orsola Malpighi

Bologna, Italy

Location

ASST-Spedali Civili

Brescia, Italy

Location

AOUC Carreggi

Florence, Italy

Location

AOU Policlinico Federico II

Napoli, Italy

Location

Azienda Ospedaliera di Perugia

Perugia, Italy

Location

Azienda Ospedaliera San Camillo Forlanini

Rome, Italy

Location

Fondazione Policlinico A. Gemelli IRCCS

Rome, Italy

Location

Istituto Nazionale Tumori Regina Elena IFO

Rome, Italy

Location

Ospedale Infantile Regina Margherita

Torino, Italy

Location

Azienda Sanitaria Universitaria Integrata di Udine

Udine, Italy

Location

Osp. di Circolo-Fondazione Macchi

Varese, Italy

Location

AOUI Verona

Verona, Italy

Location

Ospedale Donna Bambino

Verona, Italy

Location

Ospedale San Bortolo- AULSS 8 Berica

Vicenza, Italy

Location

Related Publications (6)

• De Pauw B, Walsh TJ, Donnelly JP, Stevens DA, Edwards JE, Calandra T, Pappas PG, Maertens J, Lortholary O, Kauffman CA, Denning DW, Patterson TF, Maschmeyer G, Bille J, Dismukes WE, Herbrecht R, Hope WW, Kibbler CC, Kullberg BJ, Marr KA, Munoz P, Odds FC, Perfect JR, Restrepo A, Ruhnke M, Segal BH, Sobel JD, Sorrell TC, Viscoli C, Wingard JR, Zaoutis T, Bennett JE; European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Cooperative Group; National Institute of Allergy and Infectious Diseases Mycoses Study Group (EORTC/MSG) Consensus Group. Revised definitions of invasive fungal disease from the European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Cooperative Group and the National Institute of Allergy and Infectious Diseases Mycoses Study Group (EORTC/MSG) Consensus Group. Clin Infect Dis. 2008 Jun 15;46(12):1813-21. doi: 10.1086/588660.

  PMID: 18462102 BACKGROUND

• Mercier T, Maertens J. Clinical considerations in the early treatment of invasive mould infections and disease. J Antimicrob Chemother. 2017 Mar 1;72(suppl_1):i29-i38. doi: 10.1093/jac/dkx031.

  PMID: 28355465 BACKGROUND

• Maccioni F, Vetere S, De Felice C, Al Ansari N, Micozzi A, Gentile G, Foa R, Girmenia C. Pulmonary fungal infections in patients with acute myeloid leukaemia: is it the time to revise the radiological diagnostic criteria? Mycoses. 2016 Jun;59(6):357-64. doi: 10.1111/myc.12480. Epub 2016 Feb 11.

  PMID: 26865204 BACKGROUND

• Cornely OA, Maertens J, Winston DJ, Perfect J, Ullmann AJ, Walsh TJ, Helfgott D, Holowiecki J, Stockelberg D, Goh YT, Petrini M, Hardalo C, Suresh R, Angulo-Gonzalez D. Posaconazole vs. fluconazole or itraconazole prophylaxis in patients with neutropenia. N Engl J Med. 2007 Jan 25;356(4):348-59. doi: 10.1056/NEJMoa061094.

  PMID: 17251531 BACKGROUND

• Pagano L, Verga L, Busca A, Martino B, Mitra ME, Fanci R, Ballanti S, Picardi M, Castagnola C, Cattaneo C, Nadali G, Nosari A, Candoni A, Caira M, Salutari P, Lessi F, Aversa F, Tumbarello M. Systemic antifungal treatment after posaconazole prophylaxis: results from the SEIFEM 2010-C survey. J Antimicrob Chemother. 2014 Nov;69(11):3142-7. doi: 10.1093/jac/dku227. Epub 2014 Jun 19.

  PMID: 24948702 BACKGROUND

• Facchinelli D, Marchesini G, Nadali G, Pagano L. Invasive Fungal Infections in Patients with Chronic Lymphoproliferative Disorders in the Era of Target Drugs. Mediterr J Hematol Infect Dis. 2018 Nov 1;10(1):e2018063. doi: 10.4084/MJHID.2018.063. eCollection 2018.

  PMID: 30416695 BACKGROUND

MeSH Terms

Conditions

Invasive Fungal Infections

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections

Study Officials

• Livio Pagano

  Fondazione Policlinico Universitario A. Gemelli IRCCS-UCSC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: February 26, 2019
• First Posted: July 18, 2019
• Study Start: September 1, 2019
• Primary Completion: September 30, 2021
• Study Completion: December 31, 2021
• Last Updated: October 26, 2022

Record last verified: 2022-10

Locations

IT (14)