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Posaconazole as Salvage Therapy for Aspergillus Pulmonary Infection. (Posaconazole)

Primary Purpose

Clinical Infection

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Posaconazole
Sponsored by
Taichung Veterans General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clinical Infection focused on measuring successful percentage

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Taichung Veterans General Hospital Hematology and Oncology patients with pulmonary aspergillosis, the preliminary use of effective anti-Aspergillus drugs (including amphotericin B, itraconazole, or voriconazole) 14 days later, the symptoms worsen or improve, or can not tolerate the side effects.
  • The default number of subjects 12.

Exclusion Criteria:

  • Children, minors, pregnant women, newborns, prisoners, mental illness, loss of adult decision-making capacity due to illness, the Aboriginal ... and other vulnerable groups, and critically ill patients

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Posaconazole, salvage

    Arm Description

    Posaconazole, per oral , 400 mg, bid , 8 weeks.

    Outcomes

    Primary Outcome Measures

    clinical response
    fever subsides (< 38 C) dyspnea improves ( evaluate by clinical doctors) CXR improves

    Secondary Outcome Measures

    serum galactomannan level
    follow the galactomannan level and check if it corresponds to clinical response or not.

    Full Information

    First Posted
    December 5, 2013
    Last Updated
    December 11, 2014
    Sponsor
    Taichung Veterans General Hospital
    Collaborators
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02020213
    Brief Title
    Posaconazole as Salvage Therapy for Aspergillus Pulmonary Infection.
    Acronym
    Posaconazole
    Official Title
    Effectiveness of Posaconazole as Salvage Treatment After 2 Weeks of Preemptive Antifungal Treatment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2013
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    December 2013 (undefined)
    Primary Completion Date
    December 2014 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Taichung Veterans General Hospital
    Collaborators
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Invasive Aspergillus infection (IAI) occasionally occurs in immunocompromised people. Except administrating empirical anti-fungal agent, using objective parameters to support the tentative diagnosis of an IAI in order to make the anti-fungal treatment more specifically is also important. At present, serum galactomannan (GM) test is the less-invasive, non-cultural, and time-saving examination for augmenting a diagnosis of Aspergillosis. It was suggested by Infectious Disease Society of America (IDSA) 2008 as a screening and monitoring tool for Aspergillosis , and the cut-off value was adjusted to 0.5 by USA FDA . However, in clinical practice, GM seems not to have good predicted value even the sensitivity and specificity are declaimed more than 80% . Other controversial issues include the reproducibility of GM5 and the effect of piperacillin-tazobactam or other antibiotics on the accuracy of GM baseline In this study, serum GMs are examined in two conditions, one is collected for establishing a baseline and the other is collected after piperacillin-tazobactam administration. We hope to confirm the validity of GM baseline and the effect of piperacillin-tazobactam on GM value in Taiwan.
    Detailed Description
    We try to enroll patient who are followed in hematology department in TCVGH and are diagnosed as probable pulmonary Aspergillus infection or proven pulmonary Aspergillus infection. If they have poor response to current thought effective agent for pulmonary Aspergillus (eg, amphotericin B, Voriconazole, itraconazole) 2 weeks, then they can choose to receive Posaconazole as salvage therapy in our study. However, our study wants to quantification of therapeutic response, so the enrolled patient should be agree to let us check serum galactomannan level at beginning and per 2 weeks. They also should be receive chest CT in the beginning and in the end of posaconazole treatment. The rule out timing is evaluated by clinical doctors (hematology department) per 2 weeks, if posaconazole has poor effect to their disease, the clinical doctors can decided to terminate posaconazole administration. Another effective agent will be given when posaconazole fails.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Clinical Infection
    Keywords
    successful percentage

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Posaconazole, salvage
    Arm Type
    Other
    Arm Description
    Posaconazole, per oral , 400 mg, bid , 8 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Posaconazole
    Other Intervention Name(s)
    posanol
    Intervention Description
    400 mg po bid for 8 weeks
    Primary Outcome Measure Information:
    Title
    clinical response
    Description
    fever subsides (< 38 C) dyspnea improves ( evaluate by clinical doctors) CXR improves
    Time Frame
    per 2 weeks
    Secondary Outcome Measure Information:
    Title
    serum galactomannan level
    Description
    follow the galactomannan level and check if it corresponds to clinical response or not.
    Time Frame
    per 2 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Taichung Veterans General Hospital Hematology and Oncology patients with pulmonary aspergillosis, the preliminary use of effective anti-Aspergillus drugs (including amphotericin B, itraconazole, or voriconazole) 14 days later, the symptoms worsen or improve, or can not tolerate the side effects. The default number of subjects 12. Exclusion Criteria: Children, minors, pregnant women, newborns, prisoners, mental illness, loss of adult decision-making capacity due to illness, the Aboriginal ... and other vulnerable groups, and critically ill patients
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sz-Rung Huang, Bachelar
    Organizational Affiliation
    Chief of Infection department,TCVGH Pu-Li branch
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Posaconazole as Salvage Therapy for Aspergillus Pulmonary Infection.

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