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

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• Recruitment Status: Withdrawn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

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
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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: N/A
• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Sponsors and Collaborators

Taichung Veterans General Hospital

Merck Sharp & Dohme Corp.

Investigators

• Study Director: Sz-Rung Huang, Bachelar; Chief of Infection department,TCVGH Pu-Li branch

More Information

• Responsible Party: Taichung Veterans General Hospital
• ClinicalTrials.gov Identifier: NCT02020213
• Other Study ID Numbers: SF13263
• First Posted: December 24, 2013
• Last Update Posted: December 12, 2014
• Last Verified: December 2013

Keywords provided by Taichung Veterans General Hospital:

successful percentage

Additional relevant MeSH terms:

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