Invasive AspergillosisPhase 3NCT00836875
A Study To Evaluate The Safety Of Voriconazole As Treatment Of Invasive Aspergillosis (Fungal Infection) And Other Rare Molds In Children
A Phase 3 study testing Voriconazole in people with Invasive Aspergillosis, run by Pfizer at 25 sites in 8 countries.
Trial summary
The purpose of this study is to evaluate the safety profile of voriconazole (an antifungal drug) when used in children who have invasive aspergillosis (IA) and other rare systemic fungal infections. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Invasive Aspergillosis
- What is being tested?
- Voriconazole
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 25 sitesin 8 countries
- Study dates
- May 2009to May 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Immunocompromised with clinically compatible illness.
- Diagnosis of proven or probable or possible Invasive Aspergillosis (based on a modified version of the revised EORTC/MSG consensus definitions).
- Diagnosis of infection due to Scedosporium or Fusarium species.
- Male and female from 2 to 17 years of age.
- Females with childbearing potential must have negative pregnancy test and be using appropriate contraception.
Who cannot join
- Allergy or hypersensitivity to the azole drugs.
- Female subjects who are pregnant or lactating.
- Patients who received more than four days of antifungal drugs to treat the current episode of invasive aspergillosis or rare mold infection.
- Received within 24 hours prior to enrollment drugs that may cause QT interval prolongation.
- Significant liver, kidney or heart dysfunction.
- Not expected to survive for at least 5 days.
Trial locations and contacts
25 sites in 8 countries.
25 sites in 8 countries
United States9 sites
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Childrens Hospital Los Angeles
Los Angeles, California, 90027
Children's Hospital & Research Center Oakland (CHRCO)
Oakland, California, 94609
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
Children's Pavilion, Virginia Commonwealth University Health System
Richmond, Virginia, 23219
Virginia Commonwealth University Health System, Hospital Pharmacy
Richmond, Virginia, 23298-0042
Pediatric Hematology and Oncology, Virginia Commonwealth University Health System
Richmond, Virginia, 23298
Virginia Commonwealth University/MCV Clinical Pathology
Richmond, Virginia, 23298
Virginia Commonwealth University
Richmond, Virginia, 23298
Spain5 sites
Hospital General Universitari Vall D'Hebron
Barcelona, 08035
Hospital Universitari Vall d'Hebron. Servicio de Farmacia
Barcelona, 08035
Hospital Universitario Vall d'Hebron
Barcelona, 08035
HOSPITAL UNIVERSITARIO 12 DE OCTUBRE Servicio de Farmacia
Madrid, 28041
Hospital Universitario 12 de Octubre
Madrid, 28041
Thailand3 sites
Department of Pediatrics, Faculty of Medicine, Siriraj Hospital, Mahidol University
Bangkok Noi, Bangkok, 10700
Department of Pediatrics, Faculty of Medicine, Chulalongkorn University
Patumwan, Bangkok, 10330
Department of Pediatrics, Phramongkutklao hospital
Rajathevee, Bangkok, 10400
Canada2 sites
Alberta Children's Hospital, Pediatric Oncology Office
Calgary, Alberta, T3B 6A8
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8
Czechia2 sites
Fakultni nemocnice Brno
Brno, 625 00
Fakultni nemocnice Brno
Brno, 62500
Singapore2 sites
National University Hospital
Singapore, 119074
KK Women's and Children's Hospital
Singapore, 229899
Poland1 site
Klinika Transplantacji Szpiku, Onkologii i Hematologii Dzieciecej
Wroclaw, 50-345
About this study
Official title: A Prospective, Open-label, Non-randomized, Multi-center Study To Investigate The Safety And Tolerability Of Voriconazole As Primary Therapy For Treatment Of Invasive Aspergillosis And Molds Such As Scedosporium Or Fusarium Species In Pediatric Patients.
The purpose of this study is to evaluate the safety profile of voriconazole (an antifungal drug) when used in children who have invasive aspergillosis (IA) and other rare systemic fungal infections.
- Conditions
- Invasive Aspergillosis
- Being tested
- Voriconazole
- Keywords
- Pediatrics voriconazole invasive fungal infection invasive aspergillosis immunocompromized
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VoriconazoleDrug
All subjects will receive voriconazole for a minimum of 6 weeks and a maximum of 12 weeks. All subjects must receive intravenous (IV) voriconazole for the first week of therapy.
Group 1: Subjects 2 to 11 years old and subjects 12 to 14 years old with low body weight (<50 kg) will receive 9 mg/kg IV every 12 hours (q12h) on day 1, then 8 mg/kg IV q12h starting day 2. If there is a significant clinical improvement after the first week of IV therapy, subjects may be switched to the step-down oral regimen (9 mg/kg PO q12h with a maximum dose of 350 mg PO q12h) at the discretion of the investigator.
Group 2: Subjects 12 to 17 years old (excluding 12-14-year-olds weighing <50 kg) will receive 6 mg/kg IV q12h on day 1, then 4 mg/kg IV q12h starting day 2. Similar to Group 1, subjects may be switched to the step-down oral regimen (200 mg PO q12h) at the discretion of the investigator. Oral voriconazole can be administered as tablet or oral suspension.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Children from 2 to 17 years who have possible, probable or proven invasive aspergillosis, or other rare mold infection (eg, Scedosporium and Fusarium). Receives: Drug: Voriconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AEs)
Measured: Baseline, daily while hospitalized, Days 7, 14, 28, 42, 84, and 114, at end of treatment, and up to 1 month post treatment
Secondary outcomes (4)
Percentage of Participants With a Global Response of Success
Percentage of participants with global response of success at Weeks 6 and at EOT (up to Week 12). Global response of success was defined as a participant who achieved a complete or partial global response per the investigator. Complete response was defined as resolution of all clinical signs and symptoms PLUS resolution of 90 percent (%) or more of the lesions visible on radiological studies and attributed to invasive aspergillosis (IA) at Baseline. Partial response was defined as clinical improvement PLUS 50% to <90% resolution of the radiological lesions attributed to IA at Baseline.
Measured: Weeks 6 and End of Treatment (EOT; up to Week 12)
All-Cause Mortality - Number of Participant Deaths
Number of participant deaths reported at Week 6 and at EOT (up to Week 12).
Measured: Week 6 and EOT (up to Week 12)
Attributable Mortality - Number of Participant Deaths
Number of participant deaths attributable to study drug reported at Week 6 and at EOT (up to Week 12).
Measured: Weeks 6 and EOT (up to Week 12)
Time to Death
Measured: Baseline up to 1 month post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2009 (estimated)
- Study startMay 2009
- Primary completionMay 2013
- Study completionMay 2013
Why it stopped: This protocol terminated prematurely on July 8, 2013 due to slow enrollment, not because of any safety issues or concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Invasive 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
- Non-randomised
- Masking
- None (open label)
- Enrolment
- 31 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
- NCT00836875
- Sponsor's protocol ID
- A1501080
- Other IDs
- 2008-005275-10, 2008
- Status last verified
- May 2017
- First submitted
- 3 Feb 2009
- Last updated
- 16 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Martin JM, Macias-Parra M, Mudry P, Conte U, Yan JL, Liu P, Capparella MR, Aram JA. Safety, Efficacy, and Exposure-Response of Voriconazole in Pediatric Patients With Invasive Aspergillosis, Invasive Candidiasis or Esophageal Candidiasis. Pediatr Infect Dis J. 2017 Jan;36(1):e1-e13. doi: 10.1097/INF.0000000000001339.
PubMed 27636722
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-label, Non-randomized, Multi-center Study To Investigate The Safety And Tolerability Of Voriconazole As Primary Therapy For Treatment Of Invasive Aspergillosis And Molds Such As Scedosporium Or Fusarium Species In Pediatric Patients.
- ClinicalTrials.gov ID
- NCT00836875
- Acronym / sponsor ID
- A1501080
- Conditions
- Invasive Aspergillosis
- Keywords
- Pediatrics voriconazole invasive fungal infection invasive aspergillosis immunocompromized
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This protocol terminated prematurely on July 8, 2013 due to slow enrollment, not because of any safety issues or concerns.
- Enrolment
- 31 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- May 2009 (actual)
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 4 Feb 2009 (estimated)
- Results
- Posted 23 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety profile of voriconazole (an antifungal drug) when used in children who have invasive aspergillosis (IA) and other rare systemic fungal infections.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: VoriconazoleChildren from 2 to 17 years who have possible, probable or proven invasive aspergillosis, or other rare mold infection (eg, Scedosporium and Fusarium). |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Immunocompromised with clinically compatible illness.
- Diagnosis of proven or probable or possible Invasive Aspergillosis (based on a modified version of the revised EORTC/MSG consensus definitions).
- Diagnosis of infection due to Scedosporium or Fusarium species.
- Male and female from 2 to 17 years of age.
- Females with childbearing potential must have negative pregnancy test and be using appropriate contraception.
Key exclusion criteria (6 listed)
- Allergy or hypersensitivity to the azole drugs.
- Female subjects who are pregnant or lactating.
- Patients who received more than four days of antifungal drugs to treat the current episode of invasive aspergillosis or rare mold infection.
- Received within 24 hours prior to enrollment drugs that may cause QT interval prolongation.
- Significant liver, kidney or heart 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 |
|---|---|---|
| VoriconazoleAll subjects will receive voriconazole for a minimum of 6 weeks and a maximum of 12 weeks. All subjects must receive intravenous (IV) voriconazole for the first week of therapy. Group 1: Subjects 2 to 11 years old and subjects 12 to 14 years old with low body weight (<50 kg) will receive 9 mg/kg IV every 12 hours (q12h) on day 1, then 8 mg/kg IV q12h starting day 2. If there is a significant clinical improvement after the first week of IV therapy, subjects may be switched to the step-down oral regimen (9 mg/kg PO q12h with a maximum dose of 350 mg PO q12h) at the discretion of the investigator. Group 2: Subjects 12 to 17 years old (excluding 12-14-year-olds weighing <50 kg) will receive 6 mg/kg IV q12h on day 1, then 4 mg/kg IV q12h starting day 2. Similar to Group 1, subjects may be switched to the step-down oral regimen (200 mg PO q12h) at the discretion of the investigator. Oral voriconazole can be administered as tablet or oral suspension. | Drug | 1 |
Primary outcome
Number of Participants With Adverse Events (AEs)
Time frame: Baseline, daily while hospitalized, Days 7, 14, 28, 42, 84, and 114, at end of treatment, and up to 1 month post treatment
4 secondary outcomes
Percentage of Participants With a Global Response of Success
Time frame: Weeks 6 and End of Treatment (EOT; up to Week 12)
All-Cause Mortality - Number of Participant Deaths
Time frame: Week 6 and EOT (up to Week 12)
Attributable Mortality - Number of Participant Deaths
Time frame: Weeks 6 and EOT (up to Week 12)
Time to Death
Time frame: Baseline up to 1 month post treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27636722Martin JM, Macias-Parra M, Mudry P, Conte U, Yan JL, Liu P, Capparella MR, Aram JA. Safety, Efficacy, and Exposure-Response of Voriconazole in Pediatric Patients With Invasive Aspergillosis, Invasive Candidiasis or Esophageal Candidiasis. Pediatr Infect Dis J. 2017 Jan;36(1):e1-e13. doi: 10.1097/INF.0000000000001339.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Invasive Aspergillosis
RecruitingObservational study
Natural History of Individuals With Immune System Problems That Lead to Fungal Infections
Chronic Mucocutaneous Candidiasis, Invasive Aspergillosis
RecruitingObservational study
Fungal Status and Prognosis in ABPA
ABPA, Allergic Bronchopulmonary Aspergillosis
RecruitingObservational study
Derivation and Validation of the Fungal Pneumonia Assessment and Likelihood Predictor Score
Pneumonia, Fungal Pneumonia
RecruitingObservational study
A Cohort Study of the Efficacy and Safety of Biologics in Patients With ABPA
ABPA, Biologics
Active, not recruitingObservational study
Liver Cirrhosis Patients With Invasive Pulmonary Aspergillosis: in Depth Understanding Clinical Host Risk Factors
Liver Cirrhosis, Viral Pneumonia
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
25 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Voriconazole in people with Invasive Aspergillosis, run by Pfizer at 25 sites in 8 countries.
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 5 inclusion and 6 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 16 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, Spain, Thailand, Canada, Czechia and 3 more countries. 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.
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?
Yes. Results are posted in the registry (first posted 23 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Adverse Events (AEs) (time frame: Baseline, daily while hospitalized, Days 7, 14, 28, 42, 84, and 114, at end of treatment, and up to 1 month post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00836875, which also lists 1 linked publication.
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 16 Jun 2017.