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

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ClinicalTrials.gov Identifier: NCT02020213
Recruitment Status : Withdrawn
First Posted : December 24, 2013
Last Update Posted : December 12, 2014
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Taichung Veterans General Hospital

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
Clinical Infection Drug: Posaconazole 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Posaconazole as Salvage Treatment After 2 Weeks of Preemptive Antifungal Treatment
Study Start Date : December 2013
Actual Primary Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Posaconazole, salvage
Posaconazole, per oral , 400 mg, bid , 8 weeks.
Drug: Posaconazole
400 mg po bid for 8 weeks
Other Name: posanol




Primary Outcome Measures :
  1. clinical response [ Time Frame: per 2 weeks ]
    fever subsides (< 38 C) dyspnea improves ( evaluate by clinical doctors) CXR improves


Secondary Outcome Measures :
  1. serum galactomannan level [ Time Frame: per 2 weeks ]
    follow the galactomannan level and check if it corresponds to clinical response or not.



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02020213


Sponsors and Collaborators
Taichung Veterans General Hospital
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Sz-Rung Huang, Bachelar Chief of Infection department,TCVGH Pu-Li branch

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Responsible Party: Taichung Veterans General Hospital
ClinicalTrials.gov Identifier: NCT02020213     History of Changes
Other Study ID Numbers: SF13263
First Posted: December 24, 2013    Key Record Dates
Last Update Posted: December 12, 2014
Last Verified: December 2013
Keywords provided by Taichung Veterans General Hospital:
successful percentage
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Posaconazole
Antifungal Agents
Anti-Infective Agents
Trypanocidal Agents
Antiprotozoal Agents
Antiparasitic Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs