Invasive AspergillosisNCT02396225
Concentrations of Voriconazole in Blood and BAL-fluid After Inhalation and Oral Administration
A study testing Voriconazole in people with Invasive Aspergillosis, run by University of Aarhus at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Invasive Aspergillosis
- What is being tested?
- Voriconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Invasive Aspergillosis
- Being tested
- Voriconazole
- Keywords
- voriconazole, inhalation, aerosol, epithelial lining fluid, concentration, pharmacokinetic
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VoriconazoleDrug
| Study group | Role | What they receive |
|---|---|---|
| Inhaled voriconazole | Experimental | 12 patients inhale voriconazole 40 mg b.i.d for two days Receives: Drug: Voriconazole |
| Oral Voriconazole | Active comparator | 12 patients ingest voriconazole tablets 400 mg b.i.d for one day followed by 200 mg b.i.d for one day Receives: Drug: Voriconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Voriconazole concentration in serum
Measured: 2 years
Secondary outcomes (1)
Voriconazole concentration in lunge epithelial lining fluid
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2016
- Study completionDec 2016
Why it stopped: results obtained at interrim analysis after 12 patients would not be changed by recruiting another twelwe participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive AspergillosisStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02396225
- Sponsor's protocol ID
- M-2013-242-13
- Status last verified
- May 2017
- First submitted
- 18 Mar 2015
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concentrations of Voriconazole in Blood and BAL-fluid After Inhalation and Oral Administration
- ClinicalTrials.gov ID
- NCT02396225
- Acronym / sponsor ID
- M-2013-242-13
- Conditions
- Invasive Aspergillosis
- Keywords
- voriconazole, inhalation, aerosol, epithelial lining fluid, concentration, pharmacokinetic
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: results obtained at interrim analysis after 12 patients would not be changed by recruiting another twelwe participants
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- Mar 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 24 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inhaled voriconazole | Experimental | Drug: Voriconazole12 patients inhale voriconazole 40 mg b.i.d for two days |
| Oral Voriconazole | Active comparator | Drug: Voriconazole12 patients ingest voriconazole tablets 400 mg b.i.d for one day followed by 200 mg b.i.d for one day |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Voriconazole | Drug | Inhaled voriconazole, Oral Voriconazole |
Primary outcome
Voriconazole concentration in serum
Time frame: 2 years
1 secondary outcome
Voriconazole concentration in lunge epithelial lining fluid
Time frame: 2 years
Results and safety
The study was stopped early (reason given: results obtained at interrim analysis after 12 patients would not be changed by recruiting another twelwe participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Voriconazole in people with Invasive Aspergillosis, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: results obtained at interrim analysis after 12 patients would not be changed by recruiting another twelwe participants). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Voriconazole concentration in serum (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2017.