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.
Condition or disease |
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Invasive Fungal Infections |
Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 800 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 30 Days |
Official Title: | Revision of Antifungal Strategies Definitions for Invasive Fungal Infections (Proven/Probable/Possible) in Patients With Hematological Malignancies (REDEFI-SEIFEM) |
Actual Study Start Date : | September 1, 2019 |
Estimated Primary Completion Date : | September 2021 |
Estimated Study Completion Date : | December 2021 |
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
Contact: Livio Pagano | +390630154180 | livio.pagano@unicatt.it |
Italy | |
Azienda Ospedaliera Universitaria S. Orsola Malpighi | Recruiting |
Bologna, Italy | |
Contact: Daniele Zama | |
ASST-Spedali Civili | Recruiting |
Brescia, Italy | |
Contact: Chiara Cattaneo | |
AOUC Carreggi | Recruiting |
Firenze, Italy | |
Contact: Rosa Fanci | |
AOU Policlinico Federico II | Recruiting |
Napoli, Italy | |
Contact: Marco Picardi | |
Azienda Ospedaliera di Perugia | Recruiting |
Perugia, Italy | |
Contact: Katia Perruccio | |
Azienda Ospedaliera San Camillo Forlanini | Recruiting |
Rome, Italy | |
Contact: Mariagrazia Garzia | |
Fondazione Policlinico A. Gemelli IRCCS | Recruiting |
Rome, Italy | |
Contact: Livio Pagano | |
Contact: Marianna Criscuolo | |
Istituto Nazionale Tumori Regina Elena IFO | Recruiting |
Rome, Italy | |
Contact: Francesco Marchesi | |
Ospedale Infantile Regina Margherita | Recruiting |
Torino, Italy | |
Contact: Francesca Carraro | |
Azienda Sanitaria Universitaria Integrata di Udine | Recruiting |
Udine, Italy | |
Contact: Anna Candoni | |
Osp. di Circolo-Fondazione Macchi | Recruiting |
Varese, Italy | |
Contact: Claudia Maria Basilico | |
AOUI Verona | Recruiting |
Verona, Italy | |
Contact: Gianpaolo Nadali | |
Ospedale Donna Bambino | Recruiting |
Verona, Italy | |
Contact: Simone Cesaro | |
Ospedale San Bortolo- AULSS 8 Berica | Recruiting |
Vicenza, Italy | |
Contact: Maria Chiara Tisi |
Principal Investigator: | Livio Pagano | Fondazione Policlinico Universitario A. Gemelli IRCCS-UCSC |
Tracking Information | |||||
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First Submitted Date | February 26, 2019 | ||||
First Posted Date | July 18, 2019 | ||||
Last Update Posted Date | October 23, 2020 | ||||
Actual Study Start Date | September 1, 2019 | ||||
Estimated Primary Completion Date | September 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
Rate of diagnosis Agreement in proven/probable/possible IFI in real life using EORTC/MSG Criteria [ Time Frame: 30 days ] 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
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Original Primary Outcome Measures |
Diagnosis of proven/probable/possible IFI in real life using EORTC/MSG Criteria [ Time Frame: 30 days ] 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
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Change History | |||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Revision of Antifungal Strategies Definitions for Invasive Fungal Infections in Hematological Malignancies | ||||
Official Title | Revision of Antifungal Strategies Definitions for Invasive Fungal Infections (Proven/Probable/Possible) in Patients With Hematological Malignancies (REDEFI-SEIFEM) | ||||
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. |
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Detailed Description |
Primary objective The primary objective of this study is to evaluate IFI according to clinicians' opinion vs the opinion of an independent board of experts. The independent panel, confirming or not the decision of local physician, will review all cases (blind central review). The primary output of this study is the evaluation of inter-raters agreement. Secondary objectives: 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 Study design This is a multicenter, non-interventional observational, prospective study. The duration of the study will be 18 months. The schedule for the study will be the following: Observation and data collection: 6 months Revision board: 6 months Data elaboration and paper: 6 months Materials and methods 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. We do not expect that diagnostic work-up would significantly vary among the participating centers. Minimal diagnostic work up must include: Blood cultures for fungal infection; Chest High Resolution CT-scan; Serum galactomannan; Sinus CT-scan (if indicated); Bronchoalveolar lavage (if indicated); Centers participating to the study will be selected on the basis of a questionnaire that evaluate their availability to participate to the survey (see Appendix 1). The clinical, microbiological, diagnostic and therapeutic procedures operated on these patients will be collected. An electronic CRF will be compiled for all patients at two different time points: T0 and T1. T0: at the start of antifungal treatment (study entry), 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 allogeneic stem cell transplantation); Previous IFI, neutropenia, antifungal and antibiotic prophylaxis: the local physicians must define the kind of IFI they 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 (30 days) in order to estimate the differences regarding the level of evidence of diagnosis and treatment of IFI during time. Independent central review board The experts (each case will be examined blinded by 2 different experts). The experts will review all records based on the existing guidelines, their own experience and based on the information that was known at the two time points, which may confirm or not the decision of local physician. Statistical considerations Sample size dimension The sample size will be driven by the AML patients (approximately 60-70% of the patients): Statistical analysis 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 (absolute and percentage) The primary object of the study will be achieved evaluating Fleiss' Kappa. Secondary objectives will be using descriptive statistics techniques (already described above) recruit all eligible patients during a period of 6 months until at least 600 AML patients are recruited. |
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Study Type | Observational [Patient Registry] | ||||
Study Design | Observational Model: Case-Only Time Perspective: Prospective |
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Target Follow-Up Duration | 30 Days | ||||
Biospecimen | Not Provided | ||||
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. | ||||
Condition | Invasive Fungal Infections | ||||
Intervention | Not Provided | ||||
Study Groups/Cohorts | Not Provided | ||||
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Recruiting | ||||
Estimated Enrollment |
800 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | December 2021 | ||||
Estimated Primary Completion Date | September 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | Child, Adult, Older Adult | ||||
Accepts Healthy Volunteers | No | ||||
Contacts |
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Listed Location Countries | Italy | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT04024995 | ||||
Other Study ID Numbers | REDEFI-SEIFEM | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement | Not Provided | ||||
Responsible Party | LIVIO PAGANO, Sorveglianza Epidemiologica Infezioni Fungine Emopatie Maligne | ||||
Study Sponsor | Sorveglianza Epidemiologica Infezioni Fungine Emopatie Maligne | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | Sorveglianza Epidemiologica Infezioni Fungine Emopatie Maligne | ||||
Verification Date | October 2020 |