Concentrations of Voriconazole in Blood and BAL-fluid After Inhalation and Oral Administration

Invasive Aspergillosis Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02396225
• Other study ID #: M-2013-242-13
• Status: Terminated
• Phase: N/A
• First received: March 18, 2015
• Last updated: May 8, 2017
• Start date: March 2015
• Est. completion date: December 2016

Study information

• Verified date: May 2017
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Concentrations of voriconazole in pulmonary epithelial lining fluid and in serum are compared after inhalation of 40 mg voriconazole b.i.d. for two days or oral intake of voriconazole tablets 400 mg bid for 1 day followed by 200 mg b.i.d. for one day, respectively.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Planned bronchoscopy in relation to work-up after hemoptysis or other symptom leading to bronchoscopy

• Informed written consent

• Performance status 0-1

• Ct scan of thorax without suspicion of malignancy

• Weight t = 60 og = 130 kg

• Male gender or female gender in postmenopausal state defined by amenorrhea in more than 12 months.

Exclusion Criteria:

• Voriconazole treatment up to one week before inclusion

• Se-creatinin= 100 uM

• ALAT = 70 U/l

• QT-interval > 480 ms

• Allergic reaction to voriconazole or constituents in Vfend

• Allergic reaction to other azoles

• Ischemic Heart disease, Heart failure or uncontrolled hypertension

• Treatment with statins or omeprazole, which cannot be paused for three days during voriconazole exposure

• Treatment with Efavirenz, rifabutin, ritonavir, everolimus, methadon, alfentanil, fentanyl, sufentanil, oxycodone, hydrocodone, fluconazole, aztemizol, cisaprid, pimozid, quinidine, terfenadine, carbamazepine, phenobarbital, mephobarbital, ergotamine, dihydroergotamine, rifampicine, st. johns worth, everolimus, phenytoin, warfarin, phenprocoumon, acenocoumarol, benzodiazepines as midazolam, triazolam, alprazolam, sirolimus, cyclosporine, tacrolimus, ibuprofen, diclofenac,tolbutamide, glipizide, vincristine, vinblastine or other vinca alkaloids, HIV-protease Inhibitors e.g. saquinavir, amprenavir and nelfinavir, delavirdine, nivrapine and other non-nocleaoside revers transcriptase inhibitors

Related Conditions & MeSH terms

• Aspergillosis
• Invasive Aspergillosis

Intervention

Drug:
• Voriconazole

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus C

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Voriconazole concentration in serum		2 years
Secondary	Voriconazole concentration in lunge epithelial lining fluid		2 years