<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03014934</url>
  </required_header>
  <id_info>
    <org_study_id>EBMT-8414113</org_study_id>
    <nct_id>NCT03014934</nct_id>
  </id_info>
  <brief_title>Impact of Pre-existing Invasive Aspergillosis on Allogeneic Stem Cell Transplantation</brief_title>
  <acronym>IPAT</acronym>
  <official_title>Impact of Pre-existing Invasive Aspergillosis on Allogeneic Hematopoietic Stem Cell Transplantation for Treatment of Acute Leukaemia and Myelodysplastic Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>European Society for Blood and Marrow Transplantation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>European Society for Blood and Marrow Transplantation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Via a prospective non-interventional study clinical outcome of patients with - and without -&#xD;
      history of pre-existing invasive aspergillosis undergoing allo-HSCT will be assessed, in&#xD;
      terms of non-relapse mortality overall mortality and fungal infectious morbidity.&#xD;
&#xD;
      Aim. Assessment of 1-year outcome of patients undergoing allo-HSCT with history of&#xD;
      pre-existing IA vs. no pre-existing IA.&#xD;
&#xD;
      Hypothesis. NRM in patients with pre-existing IA is not higher (by a specified margin of 10%)&#xD;
      than patients without pre-existing IA.&#xD;
&#xD;
      Study population. First allo-HSCT in patients with acute leukaemia and MDS given stem cell&#xD;
      grafts.&#xD;
&#xD;
      Cohort 1: History of probable or proven invasive aspergillosis Cohort 2: No History of&#xD;
      probable or proven invasive aspergillosis: this cohort includes also the patient with a&#xD;
      history of possible mycosis not documented microbiologically.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background &amp; Rationale. In patients with pre-existing invasive aspergillosis allo-HSCT is&#xD;
      feasible without progression of fungal infection. However, the influence of invasive&#xD;
      pulmonary aspergillosis (IA) on transplant related complications and on long term survival&#xD;
      has not been investigated in a larger patient cohort under current conditions.&#xD;
&#xD;
      Recently the IDWP and ALWP performed a retrospective analysis on the impact of preexisting&#xD;
      aspergillosis on allo-HSCT outcome.2 In summary, there was a trend towards impaired outcome&#xD;
      of allo-HSCT in patients with prior IA but there was no significant impact on important&#xD;
      allo-HSCT transplant outcomes, such as survival, GVHD and relapse. The data suggest that a&#xD;
      history of IA should not generally be considered a contraindication for allo-HSCT. To be able&#xD;
      to more precisely investigate the impact of IA on allo-HSCT, a non-interventional prospective&#xD;
      study is needed.&#xD;
&#xD;
      Primary objective:&#xD;
&#xD;
      To determine if pre-existing IA influences non-relapse mortality after allo-HSCT&#xD;
&#xD;
      Secondary objectives:&#xD;
&#xD;
      - To determine if pre-existing IA influences:&#xD;
&#xD;
        -  relapse free survival&#xD;
&#xD;
        -  overall survival&#xD;
&#xD;
        -  incidence and severity of GVHD&#xD;
&#xD;
        -  incidence of relapse&#xD;
&#xD;
        -  incidence of IA post allo-HSCT&#xD;
&#xD;
      for the subgroup of transplant with previous IA&#xD;
&#xD;
      • progression of IA&#xD;
&#xD;
      Research design:&#xD;
&#xD;
      Prospective study. Study recruitment is expected to start by May 1st, 2016. It is expected&#xD;
      that recruitment will be closed by October 31st 2017. Follow up will be till one year after&#xD;
      transplant.&#xD;
&#xD;
      Items:&#xD;
&#xD;
      Data from Med A form, Med C form for all patients, Aspergillus form for patients with&#xD;
      probable/proven IA.&#xD;
&#xD;
      Endpoint(s):&#xD;
&#xD;
      Primary endpoint: 1-year non-relapse mortality cumulative incidence&#xD;
&#xD;
      Secondary endpoints:&#xD;
&#xD;
        -  1-year relapse free survival&#xD;
&#xD;
        -  1-year overall survival&#xD;
&#xD;
        -  1-year incidence and severity of GVHD&#xD;
&#xD;
        -  1-year incidence of relapse&#xD;
&#xD;
        -  status of IA (before conditioning and at 1 year)&#xD;
&#xD;
      Study population&#xD;
&#xD;
        -  First allo-HSCT in patients with AML or&#xD;
&#xD;
        -  First allo-HSCT in patients with ALL or&#xD;
&#xD;
        -  First allo-HSCT in patients with MDS&#xD;
&#xD;
      Cohort 1: History of probable or proven invasive aspergillosis Cohort 2: No History of&#xD;
      probable or proven invasive aspergillosis&#xD;
&#xD;
      Cases: Prior IA = probable/proven IA according EORTC 2008 criteria (Cohort 1) Controls: No&#xD;
      prior proven probable IA = all other patients = those really negative for IA and those with&#xD;
      possible IA (Cohort 2)&#xD;
&#xD;
      Sample size Assuming a 20% incidence of non relapse mortality in patients without proven or&#xD;
      probable history of IA, a total of 2100 HSCTs will be needed in order to test the hypothesis&#xD;
      that the incidence of non relapse mortality in cohort 1 (HSCTs with previous history of&#xD;
      proven or probable IA) is not higher than cohort 2 (HSCTs without history of IA or with&#xD;
      previous history of possible IA) by more than a specified margin of 10%. The estimated&#xD;
      proportion of HSCTs in cohort 1 is 5%, thus 105 and 1995 HSCTs will be needed in cohort 1 and&#xD;
      cohort 2, respectively, considering an alpha=0.05, a beta=0.2.&#xD;
&#xD;
      Data Collection &amp; Statistical Analysis Plan:&#xD;
&#xD;
      (List all research variables to be collected and list all outcome variables to be analysed,&#xD;
      give a brief description of the method of analysis (in collaboration with the EBMT&#xD;
      statistician) All data collection will be performed by the IDWP Data Office (Leiden)&#xD;
      according to EBMT guidelines.&#xD;
&#xD;
      Primary endpoint: non relapse mortality The non relapse mortality will be estimated using the&#xD;
      cumulative incidence method. Death due to transplant will be considered as an event, whilst&#xD;
      relapse of the underlying disease will be considered as competing events. Patients alive at&#xD;
      the end of the follow-up will be censored at this date. Cohort 1, vs. Cohort 2 will be&#xD;
      compared by the Gray test.&#xD;
&#xD;
      A cause specific Cox model will be performed in order to estimate the risk of dying for&#xD;
      Cohort 1 respect Cohort 2.&#xD;
&#xD;
      The following variables will enter the multivariate model as possible confounders: age (as&#xD;
      continuous variable), gender (M vs. F), underlying disease (ALL vs. AML/MDS), status at SCT&#xD;
      (1st CR vs. ≥ 2 CR vs. Prim Refr/noCR), time from diagnosis to SCT (as continuous variable),&#xD;
      donor type (sibling vs. UD vs. Haplo), source of SCT (BM vs. PB vs. CB), donor age, d/r&#xD;
      gender match, d/r CMV status, conditioning regimens (MAC vs. RIC vs. TBI), type of&#xD;
      immunosuppression (in vivo T depletion y/n, in vitro T-depletion y/n), DLI post SCT (y/n),&#xD;
      centre.&#xD;
&#xD;
      Secondary endpoints Relapse free survival and overall survival will be estimated by the&#xD;
      Kaplan-Meier methods. Incidence of GvHD and incidence of relapse will be estimated by the&#xD;
      cumulative incidence methods. A cause specific Cox model will be estimated to compare Cohort&#xD;
      1 and Cohort 2; it will be adjusted by the confounders analyzed also in the primary endpoint.&#xD;
&#xD;
      The severity of GvHD will be described by descriptive statistics. Frequencies and percentages&#xD;
      will be use for categorical variables, whilst median, range, mean and standard deviation will&#xD;
      be computed for continuous variables.&#xD;
&#xD;
      Additional descriptive statistic will be separately performed in cohort 2. Main&#xD;
      characteristics of patients will be also described.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2016</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">September 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Non-relapse mortality</measure>
    <time_frame>1 year</time_frame>
    <description>One year non-relapse mortality cumulative incidence</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Relapse free survival</measure>
    <time_frame>1 year</time_frame>
    <description>One year relapse free survival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>1 year</time_frame>
    <description>One year overall survival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence and severity of Graft versus Host Disease</measure>
    <time_frame>1 year</time_frame>
    <description>One year incidence and severity of Graft versus Host Disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of relapse</measure>
    <time_frame>1 year</time_frame>
    <description>One year incidence of relapse</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Status of Invasive Aspergillosis</measure>
    <time_frame>1 year</time_frame>
    <description>Status of Invasive Aspergillosis, before conditioning and at 1 year</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">2100</enrollment>
  <condition>Invasive Aspergillosis</condition>
  <arm_group>
    <arm_group_label>Cases: Prior Invasive Aspergillosis</arm_group_label>
    <description>History of probable or proven Invasive Aspergillosis according to EORTC 2008 criteria</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Controls: No prior proven Invasive Aspergillosis</arm_group_label>
    <description>Patients really negative for Invasive Aspergillosis and those with possible Invasive Aspergillosis</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        First allo-HSCT in patients with acute leukaemia and MDS given stem cell grafts.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  First allo-HSCT&#xD;
&#xD;
          -  Acute leukaemia or MDS&#xD;
&#xD;
          -  Received stem cell grafts&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History, in the 6 months preceding HSCT, or documented presence of Invasive candida or&#xD;
             mould infections other than IA (Mucor, Fusariosis).&#xD;
&#xD;
          -  (Previous history Candida infection, both superficial or systemic, is not an exclusion&#xD;
             criteria if the patient has completely recovered from it at HSCT).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Olaf Penack, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Charite University, Berlin, Germany</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jan Styczynski</last_name>
    <role>Study Chair</role>
    <affiliation>University Hospital, Collegium Medicum UMK</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jennifer Hoek, MD</last_name>
    <phone>+31715265668</phone>
    <email>j.d.c.hoek@lumc.nl</email>
  </overall_contact>
  <location>
    <facility>
      <name>Charité Universitätsmedizin Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Renate Arnold</last_name>
      <phone>49-30-450-553-302</phone>
      <email>renate.arnold@charite.de</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Institute G. Gaslini</name>
      <address>
        <city>Genova</city>
        <zip>16148</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Edoardo Lanino, MD</last_name>
      <phone>39-010-5636-2405</phone>
      <email>edoardolanino@gaslini.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Clinica di Oncoematologia Pediatrica</name>
      <address>
        <city>Padova</city>
        <zip>35128</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Giuseppe Basso</last_name>
      <phone>39-049-821-3579</phone>
      <email>giuseppe.basso@unipd.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ospedale Infantile Regina Margherita</name>
      <address>
        <city>Torino</city>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Franca Fagioli, MD</last_name>
      <phone>+39-011-313-5360</phone>
      <email>franca.fagioli@unito.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>King Faisal Specialist Hospital &amp; Research Centre</name>
      <address>
        <city>Riyadh</city>
        <zip>11211</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mahmoud Aljurf</last_name>
      <phone>(996-1) 442-4586</phone>
      <email>maljurf@kfshrc.edu.sa</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Santa Creu i Sant Pau</name>
      <address>
        <city>Barcelona</city>
        <zip>08041</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jorge Sierra, MD</last_name>
      <phone>34-93-556-5649</phone>
      <email>tolius@santpau.cat</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Hospital</name>
      <address>
        <city>Basel</city>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Helen Baldomero</last_name>
      <phone>+41 61 265 3203</phone>
      <email>Helen.Baldomero@usb.ch</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Gazi University School of Medicine</name>
      <address>
        <city>Ankara</city>
        <zip>06500</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ulker Kocak, MD</last_name>
      <phone>+90 0312-202-60-15</phone>
      <email>ulkerkocak@gazi.edu.tr</email>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>Italy</country>
    <country>Saudi Arabia</country>
    <country>Spain</country>
    <country>Switzerland</country>
    <country>Turkey</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>January 6, 2017</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>January 13, 2021</last_update_submitted>
  <last_update_submitted_qc>January 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Aspergillosis</keyword>
  <keyword>IA</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aspergillosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03014934
org study id: EBMT-8414113
nct id: NCT03014934
lead sponsor: 
has dmc: No
Via a prospective non-interventional study clinical outcome of patients with - and without -
      history of pre-existing invasive aspergillosis undergoing allo-HSCT will be assessed, in
      terms of non-relapse mortality overall mortality and fungal infectious morbidity.

      Aim. Assessment of 1-year outcome of patients undergoing allo-HSCT with history of
      pre-existing IA vs. no pre-existing IA.

      Hypothesis. NRM in patients with pre-existing IA is not higher (by a specified margin of 10%)
      than patients without pre-existing IA.

      Study population. First allo-HSCT in patients with acute leukaemia and MDS given stem cell
      grafts.

      Cohort 1: History of probable or proven invasive aspergillosis Cohort 2: No History of
      probable or proven invasive aspergillosis: this cohort includes also the patient with a
      history of possible mycosis not documented microbiologically.
Background & Rationale. In patients with pre-existing invasive aspergillosis allo-HSCT is
      feasible without progression of fungal infection. However, the influence of invasive
      pulmonary aspergillosis (IA) on transplant related complications and on long term survival
      has not been investigated in a larger patient cohort under current conditions.

      Recently the IDWP and ALWP performed a retrospective analysis on the impact of preexisting
      aspergillosis on allo-HSCT outcome.2 In summary, there was a trend towards impaired outcome
      of allo-HSCT in patients with prior IA but there was no significant impact on important
      allo-HSCT transplant outcomes, such as survival, GVHD and relapse. The data suggest that a
      history of IA should not generally be considered a contraindication for allo-HSCT. To be able
      to more precisely investigate the impact of IA on allo-HSCT, a non-interventional prospective
      study is needed.

      Primary objective:

      To determine if pre-existing IA influences non-relapse mortality after allo-HSCT

      Secondary objectives:

      - To determine if pre-existing IA influences:

        -  relapse free survival

        -  overall survival

        -  incidence and severity of GVHD

        -  incidence of relapse

        -  incidence of IA post allo-HSCT

      for the subgroup of transplant with previous IA

      • progression of IA

      Research design:

      Prospective study. Study recruitment is expected to start by May 1st, 2016. It is expected
      that recruitment will be closed by October 31st 2017. Follow up will be till one year after
      transplant.

      Items:

      Data from Med A form, Med C form for all patients, Aspergillus form for patients with
      probable/proven IA.

      Endpoint(s):

      Primary endpoint: 1-year non-relapse mortality cumulative incidence

      Secondary endpoints:

        -  1-year relapse free survival

        -  1-year overall survival

        -  1-year incidence and severity of GVHD

        -  1-year incidence of relapse

        -  status of IA (before conditioning and at 1 year)

      Study population

        -  First allo-HSCT in patients with AML or

        -  First allo-HSCT in patients with ALL or

        -  First allo-HSCT in patients with MDS

      Cohort 1: History of probable or proven invasive aspergillosis Cohort 2: No History of
      probable or proven invasive aspergillosis

      Cases: Prior IA = probable/proven IA according EORTC 2008 criteria (Cohort 1) Controls: No
      prior proven probable IA = all other patients = those really negative for IA and those with
      possible IA (Cohort 2)

      Sample size Assuming a 20% incidence of non relapse mortality in patients without proven or
      probable history of IA, a total of 2100 HSCTs will be needed in order to test the hypothesis
      that the incidence of non relapse mortality in cohort 1 (HSCTs with previous history of
      proven or probable IA) is not higher than cohort 2 (HSCTs without history of IA or with
      previous history of possible IA) by more than a specified margin of 10%. The estimated
      proportion of HSCTs in cohort 1 is 5%, thus 105 and 1995 HSCTs will be needed in cohort 1 and
      cohort 2, respectively, considering an alpha=0.05, a beta=0.2.

      Data Collection & Statistical Analysis Plan:

      (List all research variables to be collected and list all outcome variables to be analysed,
      give a brief description of the method of analysis (in collaboration with the EBMT
      statistician) All data collection will be performed by the IDWP Data Office (Leiden)
      according to EBMT guidelines.

      Primary endpoint: non relapse mortality The non relapse mortality will be estimated using the
      cumulative incidence method. Death due to transplant will be considered as an event, whilst
      relapse of the underlying disease will be considered as competing events. Patients alive at
      the end of the follow-up will be censored at this date. Cohort 1, vs. Cohort 2 will be
      compared by the Gray test.

      A cause specific Cox model will be performed in order to estimate the risk of dying for
      Cohort 1 respect Cohort 2.

      The following variables will enter the multivariate model as possible confounders: age (as
      continuous variable), gender (M vs. F), underlying disease (ALL vs. AML/MDS), status at SCT
      (1st CR vs. ≥ 2 CR vs. Prim Refr/noCR), time from diagnosis to SCT (as continuous variable),
      donor type (sibling vs. UD vs. Haplo), source of SCT (BM vs. PB vs. CB), donor age, d/r
      gender match, d/r CMV status, conditioning regimens (MAC vs. RIC vs. TBI), type of
      immunosuppression (in vivo T depletion y/n, in vitro T-depletion y/n), DLI post SCT (y/n),
      centre.

      Secondary endpoints Relapse free survival and overall survival will be estimated by the
      Kaplan-Meier methods. Incidence of GvHD and incidence of relapse will be estimated by the
      cumulative incidence methods. A cause specific Cox model will be estimated to compare Cohort
      1 and Cohort 2; it will be adjusted by the confounders analyzed also in the primary endpoint.

      The severity of GvHD will be described by descriptive statistics. Frequencies and percentages
      will be use for categorical variables, whilst median, range, mean and standard deviation will
      be computed for continuous variables.

      Additional descriptive statistic will be separately performed in cohort 2. Main
      characteristics of patients will be also described.
observational model: Case-Control
time perspective: Prospective
measure: Non-relapse mortality
time frame: 1 year
description: One year non-relapse mortality cumulative incidence
measure: Relapse free survival
time frame: 1 year
description: One year relapse free survival
measure: Overall survival
time frame: 1 year
description: One year overall survival
measure: Incidence and severity of Graft versus Host Disease
time frame: 1 year
description: One year incidence and severity of Graft versus Host Disease
measure: Incidence of relapse
time frame: 1 year
description: One year incidence of relapse
measure: Status of Invasive Aspergillosis
time frame: 1 year
description: Status of Invasive Aspergillosis, before conditioning and at 1 year
arm group label: Cases: Prior Invasive Aspergillosis
description: History of probable or proven Invasive Aspergillosis according to EORTC 2008 criteria
arm group label: Controls: No prior proven Invasive Aspergillosis
description: Patients really negative for Invasive Aspergillosis and those with possible Invasive Aspergillosis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Olaf Penack, MD
role: Principal Investigator
affiliation: Charite University, Berlin, Germany
last name: Jan Styczynski
role: Study Chair
affiliation: University Hospital, Collegium Medicum UMK
last name: Jennifer Hoek, MD
phone: +31715265668
email: j.d.c.hoek@lumc.nl
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Germany
country: Italy
country: Saudi Arabia
country: Spain
country: Switzerland
country: Turkey
responsible party type: Sponsor
mesh term: Aspergillosis
sharing ipd: No