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Withdrawn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

About this trial
This is an interventional treatment trial for Clinical Infection focused on measuring successful percentage
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
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
NCT ID
NCT02020213
First Posted
December 5, 2013
Last Updated
December 11, 2014
Sponsor
Taichung Veterans General Hospital
Collaborators
Merck Sharp & Dohme LLC
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Withdrawn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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