AspergillosisPhase 3NCT01188759
Voriconazole And Anidulafungin Combination For Invasive Aspergillosis In Pediatric Subjects
A Phase 3 study testing Voriconazole and Anidulafungin in people with Aspergillosis and Invasive Pulmonary Aspergillosis, run by Pfizer.
Trial summary
This study aims to compare the safety, tolerability, and efficacy of voriconazole and anidulafungin in combination versus voriconazole alone in pediatric subjects aged 2 to 17 years with invasive aspergillosis. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Aspergillosis, Invasive Pulmonary Aspergillosis, Neuroaspergillosis
- What is being tested?
- Voriconazole and Anidulafungin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2012to Aug 2014
- Phase
- Phase 3
- 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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of proven, probable, or possible invasive aspergillosis.
- Hematologic malignancy or allogeneic hematopoetic stem cell transplant.
Who cannot join
- Sarcoidosis, aspergilloma, or allergic bronchopulmonary aspergillosis.
- Chronic invasive aspergillosis.
- Receipt of antifungal treatment for more than 96 hours.
- Severe liver dysfunction.
About this study
Official title: A Prospective, Randomized Trial Comparing The Safety, Tolerability, And Efficacy Of Voriconazole And Anidulafungin In Combination To That Of Voriconazole Alone When Used For Primary Therapy Of Invasive Aspergillosis in Pediatric Subjects Aged 2 to 17 Years
This study aims to compare the safety, tolerability, and efficacy of voriconazole and anidulafungin in combination versus voriconazole alone in pediatric subjects aged 2 to 17 years with invasive aspergillosis.
- Being tested
- Voriconazole, Anidulafungin
- Keywords
- Aspergillosis, Combination Therapy, Voriconazole, Anidulafungin
- Medical subject headings
- Aspergillosis, Invasive Pulmonary Aspergillosis, Neuroaspergillosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VoriconazoleDrug
For Children aged 2-11 years and adolescents aged 12-14 years weighing <50 kg:
Voriconazole 9 mg/kg IV load q12h x 24h, then 8 mg/kg IV q12h, with option to switch to oral voriconazole at 9 mg/kg q12h (maximum 350 mg) after 7 days.
For adolescents aged 12-17 years, excluding 12-14-year-olds weighing <50kg:
Voriconazole 6 mg/kg IV q12h x 24h, then 4 mg/kg IV q12h, with an option to switch to oral voriconazole at 200 mg q12h after 7 days.
Voriconazole therapy is to be given for 6-12 weeks.
AnidulafunginDrug
Anidulafungin 3 mg/kg IV load q24h x 24h (maximum 200 mg), then 1.5 mg/kg q24h (maximum 100 mg).
Anidulafungin therapy is to be given for 2-4 weeks in combination with voriconazole.
VoriconazoleDrug
For Children aged 2-11 years and adolescents aged 12-14 years weighing <50 kg:
Voriconazole 9 mg/kg IV load q12h x 24h, then 8 mg/kg IV q12h, with option to switch to oral voriconazole at 9 mg/kg q12h (maximum 350 mg) after 7 days.
For adolescents aged 12-17 years, excluding 12-14-year-olds weighing <50kg:
Voriconazole 6 mg/kg IV q12h x 24h, then 4 mg/kg IV q12h, with an option to switch to oral voriconazole at 200 mg q12h after 7 days.
Voriconazole therapy is to be given for 6-12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Voriconazole and Anidulafungin Combination | Experimental | Subjects in the combination arm will receive voriconazole and anidulafungin in combination for 2-4 weeks followed by voriconazole monotherapy to complete 6-12 weeks of therapy. Receives: Drug: Voriconazole; Drug: Anidulafungin |
| Voriconazole Monotherapy | Active comparator | Subjects in the monotherapy arm will receive voriconazole monotherapy for 6-12 weeks of therapy. Receives: Drug: Voriconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of voriconazole and anidulafungin in combination versus voriconazole alone as determined by rates of adverse events
Measured: 12 weeks
Secondary outcomes (4)
Rate of all-cause mortality at 6 weeks
Measured: 6 weeks
Rate of all-cause mortality at EOT
Measured: 12 weeks
Global response to therapy at 6 weeks
Measured: 6 weeks
Global response to therapy at EOT
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2010 (estimated)
- Study startMay 2012
- Primary completionAug 2014 (estimated)
- Study completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AspergillosisStudies of the same condition, open and under way.
- More trials run by PfizerThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01188759
- Sponsor's protocol ID
- A1501095
- Status last verified
- May 2012
- First submitted
- 24 Aug 2010
- Last updated
- 11 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Trial Comparing The Safety, Tolerability, And Efficacy Of Voriconazole And Anidulafungin In Combination To That Of Voriconazole Alone When Used For Primary Therapy Of Invasive Aspergillosis in Pediatric Subjects Aged 2 to 17 Years
- ClinicalTrials.gov ID
- NCT01188759
- Acronym / sponsor ID
- A1501095
- Keywords
- Aspergillosis, Combination Therapy, Voriconazole, Anidulafungin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 25 Aug 2010 (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.
This study aims to compare the safety, tolerability, and efficacy of voriconazole and anidulafungin in combination versus voriconazole alone in pediatric subjects aged 2 to 17 years with invasive aspergillosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Voriconazole and Anidulafungin Combination | Experimental | Drug: Voriconazole, Drug: AnidulafunginSubjects in the combination arm will receive voriconazole and anidulafungin in combination for 2-4 weeks followed by voriconazole monotherapy to complete 6-12 weeks of therapy. |
| Voriconazole Monotherapy | Active comparator | Drug: VoriconazoleSubjects in the monotherapy arm will receive voriconazole monotherapy for 6-12 weeks of therapy. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Diagnosis of proven, probable, or possible invasive aspergillosis.
- Hematologic malignancy or allogeneic hematopoetic stem cell transplant.
Key exclusion criteria (4 listed)
- Sarcoidosis, aspergilloma, or allergic bronchopulmonary aspergillosis.
- Chronic invasive aspergillosis.
- Receipt of antifungal treatment for more than 96 hours.
- Severe liver dysfunction.
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 |
|---|---|---|
| VoriconazoleFor Children aged 2-11 years and adolescents aged 12-14 years weighing <50 kg: Voriconazole 9 mg/kg IV load q12h x 24h, then 8 mg/kg IV q12h, with option to switch to oral voriconazole at 9 mg/kg q12h (maximum 350 mg) after 7 days. For adolescents aged 12-17 years, excluding 12-14-year-olds weighing <50kg: Voriconazole 6 mg/kg IV q12h x 24h, then 4 mg/kg IV q12h, with an option to switch to oral voriconazole at 200 mg q12h after 7 days. Voriconazole therapy is to be given for 6-12 weeks. | Drug | Voriconazole and Anidulafungin Combination |
| AnidulafunginAnidulafungin 3 mg/kg IV load q24h x 24h (maximum 200 mg), then 1.5 mg/kg q24h (maximum 100 mg). Anidulafungin therapy is to be given for 2-4 weeks in combination with voriconazole. | Drug | Voriconazole and Anidulafungin Combination |
| VoriconazoleFor Children aged 2-11 years and adolescents aged 12-14 years weighing <50 kg: Voriconazole 9 mg/kg IV load q12h x 24h, then 8 mg/kg IV q12h, with option to switch to oral voriconazole at 9 mg/kg q12h (maximum 350 mg) after 7 days. For adolescents aged 12-17 years, excluding 12-14-year-olds weighing <50kg: Voriconazole 6 mg/kg IV q12h x 24h, then 4 mg/kg IV q12h, with an option to switch to oral voriconazole at 200 mg q12h after 7 days. Voriconazole therapy is to be given for 6-12 weeks. | Drug | Voriconazole Monotherapy |
Primary outcome
Safety and tolerability of voriconazole and anidulafungin in combination versus voriconazole alone as determined by rates of adverse events
Time frame: 12 weeks
4 secondary outcomes
Rate of all-cause mortality at 6 weeks
Time frame: 6 weeks
Rate of all-cause mortality at EOT
Time frame: 12 weeks
Global response to therapy at 6 weeks
Time frame: 6 weeks
Global response to therapy at EOT
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2012.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Voriconazole and Anidulafungin in people with Aspergillosis and Invasive Pulmonary Aspergillosis, run by Pfizer.
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 2 inclusion and 4 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: withdrawn, as of the sponsor's last update on 11 May 2012. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Safety and tolerability of voriconazole and anidulafungin in combination versus voriconazole alone as determined by rates of adverse events (time frame: 12 weeks). 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 11 May 2012.