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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Status: Withdrawn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


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.


Minimum age: 20 Years. Maximum age: 65 Years. Gender(s): Both.


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

Page last updated: August 23, 2015

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