<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/NCT03799809</url>
  </required_header>
  <id_info>
    <org_study_id>AIIMS SACHIN</org_study_id>
    <nct_id>NCT03799809</nct_id>
  </id_info>
  <brief_title>Efficacy of Intrabronchial Voriconazole Instillation for Inoperable Pulmonary Aspergilloma</brief_title>
  <official_title>Efficacy of Intrabronchial Voriconazole Instillation for Inoperable Pulmonary Aspergilloma- a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>All India Institute of Medical Sciences, New Delhi</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>All India Institute of Medical Sciences, New Delhi</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pulmonary aspergillomas are a common cause of recurrent hemoptysis which may be moderate to&#xD;
      severe in 2 to 50 % of cases and may be life threatening. Surgical resection, though&#xD;
      curative, may not be feasible in significant number of patients and also associated&#xD;
      significant post op complications. Bronchial artery embolisation (BAE) is effective for acute&#xD;
      control of hemoptysis, however recurrences may occur in upto a quarter of subjects over a 1&#xD;
      year period.&#xD;
&#xD;
      Aspergilloma is caused by a fungus hence systemic antifungals seem appropriate choice.&#xD;
      However the fungus only partially touch the walls of the cavities containing them and rarely&#xD;
      come into contact with the bloodstream. This is the major reason why the systemic&#xD;
      administration of antifungal agents is ineffective in eradicating the condition.&#xD;
&#xD;
      If surgical resection is not a treatment option to control recurrent hemoptysis, instillation&#xD;
      of antifungal agents in an aspergilloma cavity could be considered(QoE II).The instillation&#xD;
      of antifungal directly into the cavity (intra-cavitatory) containing aspergilloma brings the&#xD;
      drug in contact with the fungus. Thus may lead to antifungal action and shrinkage or complete&#xD;
      disappearance of aspergilloma. This can be achieved either by percutaneous route or&#xD;
      bronchoscopically. Percutaneous approaches have been investigated however they can sometimes&#xD;
      cause fungal spread in thoracic space resulting in fungal empyema which should be carefully&#xD;
      avoided. Endobronchial instillation of antifungals have been investigated and found to be&#xD;
      safe and effective in controlling hemoptysis, however published data comprise of case reports&#xD;
      or small case series.&#xD;
&#xD;
      Recently we have published our experience of intrabronchial voriconazole in aspergilloma&#xD;
      among 82 patients and found to be safe and effective in hemoptysis control, with transient&#xD;
      post procedure cough as an adverse effect with no major serious adverse events. Multiple&#xD;
      small studies and case reports have published the safety and efficacy of voriconazole.&#xD;
      However, a quality data in the form of randomized controlled trial (RCT) is not there.&#xD;
      Therefore, we planned this RCT to assess the efficacy of intrabronchial voriconazole in&#xD;
      inoperable aspergilloma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary Objective : To compare the percentage of patients achieving reduction in hemoptysis&#xD;
      in intrabronchial voriconazole with standard medical therapy group vs standard medical&#xD;
      therapy alone for inoperable symptomatic pulmonary aspergilloma.&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
        1. To compare the percentage of patients who have complete cessation of hemoptysis after 3&#xD;
           months.&#xD;
&#xD;
        2. To compare the percentage of patients having recurrence of hemoptysis during 3 months&#xD;
           follow up.&#xD;
&#xD;
        3. To compare the severity of hemoptysis during recurrence in both groups.&#xD;
&#xD;
        4. To compare the change in size of aspergilloma after 3 - 6 months following last&#xD;
           intrabronchial voriconazole instillation.&#xD;
&#xD;
        5. To compare the percentage of patients who need BAE during anytime till 3 - 6months.&#xD;
&#xD;
        6. To compare the percentage of patients with symptomatic improvement in Dyspnea On&#xD;
           Exertion, Cough and recurrent respiratory infections.&#xD;
&#xD;
      Number of Patients: 30 patients in each arm (Intrabronchial voriconazole with Standard&#xD;
      medical therapy vs Standard medical therapy alone)&#xD;
&#xD;
      Study Design : Prospective Randomized control study&#xD;
&#xD;
      Dosages of drug - 400 mg iv preparation of Voriconazole every week for 4 sessions&#xD;
&#xD;
      Duration of follow-up - 3-6 months&#xD;
&#xD;
      Brief Methodology: Patients with aspergilloma who presented with hemoptysis will be screened&#xD;
      for inclusion in the study. Diagnosis of aspergilloma will be based on characteristic&#xD;
      computed tomography (CT) features with microbiological or serological evidence of Aspergillus&#xD;
      (Aspergillus specific Ig G). The patients fulfilling the inclusion criteria will be taken&#xD;
      informed consent and randomized into one of the two arms of intervention.&#xD;
&#xD;
      Arm 1: Will receive 400 mg of Intrabronchial Voriconazole every week for 4 weeks along with&#xD;
      standard medical therapy.&#xD;
&#xD;
      Arm 2: Will receive standard medical therapy alone (hemostatics, anti-tussive and others as&#xD;
      deemed appropriate by treating physician)&#xD;
&#xD;
      All subjects in arm 1 will undergo fiberoptic bronchoscopy (FOB) following standard protocol&#xD;
      under local anesthesia with supplemental oxygen and continuous hemodynamic monitoring. After&#xD;
      identifying the segmental/sub-segmental bronchus of interest (as identified by CT) or cavity&#xD;
      (if visible) the study drug voriconazole, will be instilled. The bronchoscope will be kept&#xD;
      wedged for 60 seconds to prevent back leakage of the solution and then slowly withdrawn&#xD;
      without applying suction. The patient will be kept in right or left lateral position&#xD;
      (depending on the side of involvement) for the next 20 minutes. Following this patients will&#xD;
      be observed for 48 hours for cessation of hemoptysis before discharge. The procedure will be&#xD;
      done on day 1 of each week for 4 weeks in arm 1.&#xD;
&#xD;
      All patients will receive standard medical treatment for hemoptysis including appropriate&#xD;
      positioning, airway protection, blood product transfusions, antitussives, tranexamic acid,&#xD;
      and antimicrobial therapy as clinically indicated. BAE shall be offered to all patients if&#xD;
      indicated.&#xD;
&#xD;
      Mild hemoptysis shall be defined as &lt; 50 ml in 24 hrs, moderate hemoptysis as 50-200 ml in 24&#xD;
      hrs and massive hemoptysis as 200-600 ml in 24 hrs or any amount causing hemodynamic&#xD;
      compromise/threatening ventilation.&#xD;
&#xD;
      Records will be reviewed regarding demographics, primary etiology leading to fibrocavitary&#xD;
      disease, duration and severity of hemoptysis/ other constitutional symptoms, extent of&#xD;
      disease (unilateral, bilateral, associated pleural or parenchymal changes), simple vs complex&#xD;
      aspergilloma. Size of index aspergilloma. The number of patients requiring emergency or&#xD;
      hospital admission due to recurrent hemoptysis, and subsequent treatment details will be&#xD;
      recorded.&#xD;
&#xD;
      All patients will be followed up for 3-6 months. During follow up patients will be assessed&#xD;
      for symptoms and severity, successful cessation of hemoptysis, requirement of BAE due to&#xD;
      persistent or increased hemoptysis, number of sessions required for symptomatic&#xD;
      improvement/cessation of hemoptysis, hemoptysis-free interval, recurrence of hemoptysis will&#xD;
      be noted. Pre and post procedure CT scans (low dose limited CT through aspergilloma) will be&#xD;
      compared by an independent radiologist blinded to the clinical outcome. Size of index&#xD;
      aspergilloma shall be determined by addition of maximum diameter of largest length and width&#xD;
      of the visible lesion. CTs shall be compared for documenting change in the size of index&#xD;
      aspergilloma and decrease/disappearance of the cavity. On the basis of these parameters,&#xD;
      aspergillomas will be described as no interval change, increased or decreased aspergilloma&#xD;
      size, or disappearance and emptying of the cavity.&#xD;
&#xD;
      Outcomes in the form of reduction/cessation of hemoptysis, decrease in size of aspergilloma,&#xD;
      overall symptomatic improvement and mortality shall be recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 1, 2016</start_date>
  <completion_date type="Anticipated">January 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2018</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To compare the percentage of patients achieving reduction in hemoptysis in intrabronchial voriconazole with standard medical therapy group vs standard medical therapy alone for inoperable pulmonary aspergilloma at 3 months.</measure>
    <time_frame>3 months follow up</time_frame>
    <description>Percentage of patients achieving reduction in hemoptysis in intrabronchial voriconazole with standard medical therapy group vs standard medical therapy alone for inoperable pulmonary aspergilloma at 3 months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To compare the percentage of patients who have complete cessation of hemoptysis after 3 months.</measure>
    <time_frame>3 months follow up</time_frame>
    <description>percentage of patients who have complete cessation of hemoptysis after 3 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To compare the percentage of patients having recurrence of hemoptysis during 3 months follow up.</measure>
    <time_frame>3 months follow up</time_frame>
    <description>percentage of patients having recurrence of hemoptysis during 3 months follow up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To compare the severity of hemoptysis during recurrence in both groups.</measure>
    <time_frame>3 months follow up</time_frame>
    <description>severity of hemoptysis during recurrence in both groups shall be compared with visual analogue scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To compare the change in size of aspergilloma after 3 months following last intrabronchial voriconazole instillation.</measure>
    <time_frame>3 months follow up</time_frame>
    <description>change in size of aspergilloma after 3 months following last intrabronchial voriconazole instillation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To compare the percentage of patients who need BAE during anytime till 3 months.</measure>
    <time_frame>3 months follow up</time_frame>
    <description>percentage of patients who need BAE during anytime till 3 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To compare the percentage of patients with symptomatic improvement in Dyspnea On Exertion, Cough and hemoptysis.</measure>
    <time_frame>3 months follow up</time_frame>
    <description>percentage of patients with symptomatic improvement in Dyspnea On Exertion, Cough and hemoptysis.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Aspergilloma</condition>
  <arm_group>
    <arm_group_label>Voriconazole</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Will receive 400 mg of Intrabronchial Voriconazole every week for 4 weeks along with standard medical therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Will receive standard medical therapy alone (hemostatics, anti-tussive and others as deemed appropriate by treating physician)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intrabronchial Voriconazole instillation</intervention_name>
    <description>Efficacy of intrabronchial voriconazole instillation for inoperable pulmonary aspergilloma</description>
    <arm_group_label>Voriconazole</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with mild to moderate hemoptysis AND inoperable aspergilloma/ those unwilling&#xD;
             for surgery.&#xD;
&#xD;
          -  Who have no contra-indication of flexible fibre-optic bronchoscopy&#xD;
&#xD;
          -  Age &gt; 18 yrs AND&#xD;
&#xD;
          -  Given the written informed consent to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient who are not fit for FOB (e.g. hemodynamic instability)&#xD;
&#xD;
          -  Patient who have life threatening hemoptysis requiring immediate bronchial artery&#xD;
             embolization&#xD;
&#xD;
          -  Patients who have underwent BAE in last 3 months&#xD;
&#xD;
          -  Pregnant woman&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>SACHIN D, MD</last_name>
    <phone>8129840208</phone>
    <email>sachinmedico@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>All India Institute of Medical Sciences</name>
      <address>
        <city>New Delhi</city>
        <state>Delhi</state>
        <zip>110029</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sachin D, MD</last_name>
      <phone>8129840208</phone>
      <email>sachinmedico@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>October 20, 2018</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>January 9, 2019</last_update_submitted>
  <last_update_submitted_qc>January 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>All India Institute of Medical Sciences, New Delhi</investigator_affiliation>
    <investigator_full_name>DR SACHIN D</investigator_full_name>
    <investigator_title>senior resident</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Voriconazole</mesh_term>
  </intervention_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/NCT03799809
org study id: AIIMS SACHIN
nct id: NCT03799809
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Pulmonary aspergillomas are a common cause of recurrent hemoptysis which may be moderate to
      severe in 2 to 50 % of cases and may be life threatening. Surgical resection, though
      curative, may not be feasible in significant number of patients and also associated
      significant post op complications. Bronchial artery embolisation (BAE) is effective for acute
      control of hemoptysis, however recurrences may occur in upto a quarter of subjects over a 1
      year period.

      Aspergilloma is caused by a fungus hence systemic antifungals seem appropriate choice.
      However the fungus only partially touch the walls of the cavities containing them and rarely
      come into contact with the bloodstream. This is the major reason why the systemic
      administration of antifungal agents is ineffective in eradicating the condition.

      If surgical resection is not a treatment option to control recurrent hemoptysis, instillation
      of antifungal agents in an aspergilloma cavity could be considered(QoE II).The instillation
      of antifungal directly into the cavity (intra-cavitatory) containing aspergilloma brings the
      drug in contact with the fungus. Thus may lead to antifungal action and shrinkage or complete
      disappearance of aspergilloma. This can be achieved either by percutaneous route or
      bronchoscopically. Percutaneous approaches have been investigated however they can sometimes
      cause fungal spread in thoracic space resulting in fungal empyema which should be carefully
      avoided. Endobronchial instillation of antifungals have been investigated and found to be
      safe and effective in controlling hemoptysis, however published data comprise of case reports
      or small case series.

      Recently we have published our experience of intrabronchial voriconazole in aspergilloma
      among 82 patients and found to be safe and effective in hemoptysis control, with transient
      post procedure cough as an adverse effect with no major serious adverse events. Multiple
      small studies and case reports have published the safety and efficacy of voriconazole.
      However, a quality data in the form of randomized controlled trial (RCT) is not there.
      Therefore, we planned this RCT to assess the efficacy of intrabronchial voriconazole in
      inoperable aspergilloma.
Primary Objective : To compare the percentage of patients achieving reduction in hemoptysis
      in intrabronchial voriconazole with standard medical therapy group vs standard medical
      therapy alone for inoperable symptomatic pulmonary aspergilloma.

      Secondary Objectives:

        1. To compare the percentage of patients who have complete cessation of hemoptysis after 3
           months.

        2. To compare the percentage of patients having recurrence of hemoptysis during 3 months
           follow up.

        3. To compare the severity of hemoptysis during recurrence in both groups.

        4. To compare the change in size of aspergilloma after 3 - 6 months following last
           intrabronchial voriconazole instillation.

        5. To compare the percentage of patients who need BAE during anytime till 3 - 6months.

        6. To compare the percentage of patients with symptomatic improvement in Dyspnea On
           Exertion, Cough and recurrent respiratory infections.

      Number of Patients: 30 patients in each arm (Intrabronchial voriconazole with Standard
      medical therapy vs Standard medical therapy alone)

      Study Design : Prospective Randomized control study

      Dosages of drug - 400 mg iv preparation of Voriconazole every week for 4 sessions

      Duration of follow-up - 3-6 months

      Brief Methodology: Patients with aspergilloma who presented with hemoptysis will be screened
      for inclusion in the study. Diagnosis of aspergilloma will be based on characteristic
      computed tomography (CT) features with microbiological or serological evidence of Aspergillus
      (Aspergillus specific Ig G). The patients fulfilling the inclusion criteria will be taken
      informed consent and randomized into one of the two arms of intervention.

      Arm 1: Will receive 400 mg of Intrabronchial Voriconazole every week for 4 weeks along with
      standard medical therapy.

      Arm 2: Will receive standard medical therapy alone (hemostatics, anti-tussive and others as
      deemed appropriate by treating physician)

      All subjects in arm 1 will undergo fiberoptic bronchoscopy (FOB) following standard protocol
      under local anesthesia with supplemental oxygen and continuous hemodynamic monitoring. After
      identifying the segmental/sub-segmental bronchus of interest (as identified by CT) or cavity
      (if visible) the study drug voriconazole, will be instilled. The bronchoscope will be kept
      wedged for 60 seconds to prevent back leakage of the solution and then slowly withdrawn
      without applying suction. The patient will be kept in right or left lateral position
      (depending on the side of involvement) for the next 20 minutes. Following this patients will
      be observed for 48 hours for cessation of hemoptysis before discharge. The procedure will be
      done on day 1 of each week for 4 weeks in arm 1.

      All patients will receive standard medical treatment for hemoptysis including appropriate
      positioning, airway protection, blood product transfusions, antitussives, tranexamic acid,
      and antimicrobial therapy as clinically indicated. BAE shall be offered to all patients if
      indicated.

      Mild hemoptysis shall be defined as < 50 ml in 24 hrs, moderate hemoptysis as 50-200 ml in 24
      hrs and massive hemoptysis as 200-600 ml in 24 hrs or any amount causing hemodynamic
      compromise/threatening ventilation.

      Records will be reviewed regarding demographics, primary etiology leading to fibrocavitary
      disease, duration and severity of hemoptysis/ other constitutional symptoms, extent of
      disease (unilateral, bilateral, associated pleural or parenchymal changes), simple vs complex
      aspergilloma. Size of index aspergilloma. The number of patients requiring emergency or
      hospital admission due to recurrent hemoptysis, and subsequent treatment details will be
      recorded.

      All patients will be followed up for 3-6 months. During follow up patients will be assessed
      for symptoms and severity, successful cessation of hemoptysis, requirement of BAE due to
      persistent or increased hemoptysis, number of sessions required for symptomatic
      improvement/cessation of hemoptysis, hemoptysis-free interval, recurrence of hemoptysis will
      be noted. Pre and post procedure CT scans (low dose limited CT through aspergilloma) will be
      compared by an independent radiologist blinded to the clinical outcome. Size of index
      aspergilloma shall be determined by addition of maximum diameter of largest length and width
      of the visible lesion. CTs shall be compared for documenting change in the size of index
      aspergilloma and decrease/disappearance of the cavity. On the basis of these parameters,
      aspergillomas will be described as no interval change, increased or decreased aspergilloma
      size, or disappearance and emptying of the cavity.

      Outcomes in the form of reduction/cessation of hemoptysis, decrease in size of aspergilloma,
      overall symptomatic improvement and mortality shall be recorded.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: To compare the percentage of patients achieving reduction in hemoptysis in intrabronchial voriconazole with standard medical therapy group vs standard medical therapy alone for inoperable pulmonary aspergilloma at 3 months.
time frame: 3 months follow up
description: Percentage of patients achieving reduction in hemoptysis in intrabronchial voriconazole with standard medical therapy group vs standard medical therapy alone for inoperable pulmonary aspergilloma at 3 months.
measure: To compare the percentage of patients who have complete cessation of hemoptysis after 3 months.
time frame: 3 months follow up
description: percentage of patients who have complete cessation of hemoptysis after 3 months.
measure: To compare the percentage of patients having recurrence of hemoptysis during 3 months follow up.
time frame: 3 months follow up
description: percentage of patients having recurrence of hemoptysis during 3 months follow up.
measure: To compare the severity of hemoptysis during recurrence in both groups.
time frame: 3 months follow up
description: severity of hemoptysis during recurrence in both groups shall be compared with visual analogue scale.
measure: To compare the change in size of aspergilloma after 3 months following last intrabronchial voriconazole instillation.
time frame: 3 months follow up
description: change in size of aspergilloma after 3 months following last intrabronchial voriconazole instillation.
measure: To compare the percentage of patients who need BAE during anytime till 3 months.
time frame: 3 months follow up
description: percentage of patients who need BAE during anytime till 3 months.
measure: To compare the percentage of patients with symptomatic improvement in Dyspnea On Exertion, Cough and hemoptysis.
time frame: 3 months follow up
description: percentage of patients with symptomatic improvement in Dyspnea On Exertion, Cough and hemoptysis.
arm group label: Voriconazole
arm group type: Active Comparator
description: Will receive 400 mg of Intrabronchial Voriconazole every week for 4 weeks along with standard medical therapy.
arm group label: Control
arm group type: No Intervention
description: Will receive standard medical therapy alone (hemostatics, anti-tussive and others as deemed appropriate by treating physician)
intervention type: Drug
intervention name: Intrabronchial Voriconazole instillation
description: Efficacy of intrabronchial voriconazole instillation for inoperable pulmonary aspergilloma
arm group label: Voriconazole
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: SACHIN D, MD
phone: 8129840208
email: sachinmedico@gmail.com
facility: 
status: Recruiting
contact: 
country: India
responsible party type: Principal Investigator
investigator affiliation: All India Institute of Medical Sciences, New Delhi
investigator full name: DR SACHIN D
investigator title: senior resident
mesh term: Voriconazole
sharing ipd: No