Posaconazole as Salvage Therapy for Aspergillus Pulmonary Infection.

NCT02020213 | Withdrawn Phase 4

• 1 other identifier: SF13263
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Clinical Infection

Keywords

successful percentage

Outcome Measures

Primary Outcomes (1)

• clinical response

  fever subsides (\< 38 C) dyspnea improves ( evaluate by clinical doctors) CXR improves

  per 2 weeks

Secondary Outcomes (1)

• serum galactomannan level

  per 2 weeks

Study Arms (1)

Posaconazole, salvage

OTHER

Posaconazole, per oral , 400 mg, bid , 8 weeks.

Drug: Posaconazole

Interventions

Posaconazole DRUG

400 mg po bid for 8 weeks

Also known as: posanol

Posaconazole, salvage

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Taichung Veterans General Hospital: lead
• Merck Sharp & Dohme LLC: collaborator

MeSH Terms

Conditions

Communicable Diseases

Interventions

posaconazole

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sz-Rung Huang, Bachelar

  Chief of Infection department,TCVGH Pu-Li branch

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2013
• First Posted: December 24, 2013
• Study Start: December 1, 2013
• Primary Completion: December 1, 2014
• Last Updated: December 12, 2014

Record last verified: 2013-12