Posaconazole as Salvage Therapy for Aspergillus Pulmonary Infection.
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Posaconazole, salvage Posaconazole, per oral , 400 mg, bid , 8 weeks. |
Drug: Posaconazole
400 mg po bid for 8 weeks
Other Names:
|
Outcome Measures
Primary Outcome Measures
- clinical response [per 2 weeks]
fever subsides (< 38 C) dyspnea improves ( evaluate by clinical doctors) CXR improves
Secondary Outcome Measures
- serum galactomannan level [per 2 weeks]
follow the galactomannan level and check if it corresponds to clinical response or not.
Eligibility Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Taichung Veterans General Hospital
- Merck Sharp & Dohme LLC
Investigators
- Study Director: Sz-Rung Huang, Bachelar, Chief of Infection department,TCVGH Pu-Li branch
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SF13263