Posaconazole as Salvage Therapy for Aspergillus Pulmonary Infection.
Information source: Taichung Veterans General Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Clinical Infection
Intervention: Posaconazole (Drug)
Phase: Phase 4
Status: Withdrawn
Sponsored by: Taichung Veterans General Hospital Official(s) and/or principal investigator(s): Sz-Rung Huang, Bachelar, Study Director, Affiliation: Chief of Infection department,TCVGH Pu-Li branch
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.
Clinical Details
Official title: Effectiveness of Posaconazole as Salvage Treatment After 2 Weeks of Preemptive Antifungal Treatment
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: clinical response
Secondary outcome: serum galactomannan level
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.
Eligibility
Minimum age: 20 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: December 2013
Last updated: December 11, 2014
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