CandidiasisPhase 3NCT01092832
A Study Of The Safety, Tolerability And Effective Of Voriconazole For The Treatment Of Serious Candida Infection And Candida Infection Of The Throat In Pediatric Patients
A Phase 3 study testing voriconazole in people with Candidiasis, run by Pfizer at 14 sites in 8 countries.
Trial summary
The purpose of this study is to determine whether voriconazole is safe and effective for the treatment of serious Candida infection and Candida infection of the esophagus in children and adolescents. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Candidiasis
- 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
- 23 participants
- Where
- 14 sitesin 8 countries
- Study dates
- Oct 2010to Jun 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
- Male or female 2 to <18 years of age; Subjects 2 to <12 years of age will be permitted to enroll in this study only after a Pfizer sponsored pharmacokinetic study confirms the proposed dosage corresponding to this age group is appropriate.
- Patients with confirmed Candida infection of the blood, body tissues, or the esophagus.
- Patient's doctor feels voriconazole is an appropriate choice of therapy.
Who cannot join
- A known allergy to voriconazole or to azole to antifungal drugs.
- Females who are pregnant, lactating (breast feeding) or planning a pregnancy during the course of the study, or who are of childbearing potential and not using highly effective method of birth control.
- A patient who is receiving treatment with a drug know to interfere with the heart's electrical system (QTc prolongation).
- A patient who is receiving treatment with a drug that is not permitted to be used with voriconazole.
- For primary therapy: a patient who has received more than 48 hours of antifungal therapy for the current episode of Candida infection.
- A patient with significant underlying liver disease at the time of enrollment in the study.
- A patient with significant renal disease (CrCl < 50 ml/min) at the time of enrollment in the study.
- A patient with a high likelihood of death within 72 hours of study enrollment due to factors unrelated to Candida infection.
Trial locations and contacts
14 sites in 8 countries.
14 sites in 8 countries
Hong Kong3 sites
Department of Paediatrics and Adolescent Medicine
Hong Kong, 0
Queen Mary Hospital
Hong Kong
The Chinese University of Hong Kong, Prince of Wales Hospital
Shatin, N.T.
Hungary3 sites
Semmelweis Egyetem, II. sz. Szemeszeti Klinika
Budapest, 1085
Semmelweis Egyetem, II. sz. Gyermekgyogyaszati Klinika
Budapest, 1094
Fovarosi Onkormanyzat Egyesitett Szent Istvan és Szent Laszlo Korhaz-Rendelointezet
Budapest, 1097
China2 sites
Beijing Children's Hospital, Capital University of Medical Sciences
Beijing, 100045
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Philippines2 sites
Medical Research Laboratory Philippine General Hospital University of the Philippines
Ermita, Manila, 1000
Rm. 112 ICHHD, National Institutes of Health-University of the Philippines Manila
Manila, 1000
Mexico1 site
Instituto Nacional de Pediatria
Colonia Insurgentes Cuicuilco, Delegacion Coyoacan, Mexico City, 04530
Poland1 site
Oddzial Pediatryczny I- Hematologiczno-Onkologiczny
Olsztyn, 10-561
Slovakia1 site
Detska fakultna nemocnica s poliklinikou Bratislava
Bratislava, 833 40
About this study
Official title: A Prospective, Open-label, Non-comparative Study To Assess The Safety, Tolerability And Efficacy Of Voriconazole For The Primary And Salvage Treatment Of Invasive Candidiasis, Candidemia, And Esophageal Candidiasis In Pediatric Subjects
The purpose of this study is to determine whether voriconazole is safe and effective for the treatment of serious Candida infection and Candida infection of the esophagus in children and adolescents.
- Conditions
- Candidiasis
- Being tested
- voriconazole
- Keywords
- Invasive Candidiasis Candidemia Esophageal Candidiasis
- Medical subject headings
- Candidiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
voriconazoleDrug
Also called Vfend
Subjects 12 - <18 yrs (excluding subjects 12 - 14 yrs weighing <50kg): For IC, the loading dose is 6 mg/kg IV q12h on Day 1, followed by 4 mg/kg IV q12h thereafter. Oral therapy, if given, will be administered at a dose of 200 mg q12h. For EC, no loading dose is required, and subjects will be initiated on 3 mg/kg IV q12h. Oral therapy, if given, will be administered at a dose of 200 mg q12h.
Subjects 2 - <12 yrs, and subjects 12 - 14 weighing <50kg: For IC, the loading dose is 9 mg/kg IV q12h on Day 1, followed by 8 mg/kg IV q12h thereafter. For EC, no loading dose is required, and subjects will be initiated on 4 mg/kg IV q12. Oral therapy, if given, will be administered at a dose of 9 mg/kg q12h (maximum initial dose of 300 mg).
Subjects will be treated for a minimum of 14 days for invasive candidiasis/candidemia or a minimum of 7 days for esophageal candidiasis. Subjects will be treated for up to a maximum of 42 days.
| Study group | Role | What they receive |
|---|---|---|
| Active voriconazole | Experimental | All subjects in this study will receive active voriconazole in an open-label fashion; there is no comparator in this study. Receives: Drug: voriconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Adverse Events - Overall Summary
Percentage of participants with adverse events (AEs), serious adverse events (SAEs), severe AEs, who discontinued due to AEs, or who had dose redued or temporarily discontinued due to AEs.
Measured: Baseline up to 1 month follow-up
Secondary outcomes (3)
Percentage of Participants With a Global Response of Success at End of Treatment (EOT)
Global response was determined programmatically based on investigator assessment of clinical and microbiological response. Global response of success was defined as clinical cure or improvement AND microbiological eradication or presumed eradication. Exact 95 percent (%) confidence interval for binomial proportions using Clopper-Pearson method.
Measured: EOT (from 7 to 42 days of treatment)
All-Cause Mortality - Number of Participant Deaths
Measured: Day 28 and 1 Month Follow-up
Time to Death
Measured: Baseline up to 1 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2010 (estimated)
- Study startOct 2010
- Primary completionMay 2013
- Study completionJun 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 CandidiasisStudies 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
- 23 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
- NCT01092832
- Sponsor's protocol ID
- A1501085
- Other IDs
- 2009-012848-16, 2009
- Status last verified
- May 2016
- First submitted
- 10 Mar 2010
- Last updated
- 23 Jun 2016
- 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 23 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-label, Non-comparative Study To Assess The Safety, Tolerability And Efficacy Of Voriconazole For The Primary And Salvage Treatment Of Invasive Candidiasis, Candidemia, And Esophageal Candidiasis In Pediatric Subjects
- ClinicalTrials.gov ID
- NCT01092832
- Acronym / sponsor ID
- A1501085
- Conditions
- Candidiasis
- Keywords
- Invasive Candidiasis Candidemia Esophageal Candidiasis
- 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
- 23 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- May 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 25 Mar 2010 (estimated)
- Results
- Posted 17 Aug 2015
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 determine whether voriconazole is safe and effective for the treatment of serious Candida infection and Candida infection of the esophagus in children and adolescents.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active voriconazole | Experimental | Drug: voriconazoleAll subjects in this study will receive active voriconazole in an open-label fashion; there is no comparator in this study. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Male or female 2 to <18 years of age; Subjects 2 to <12 years of age will be permitted to enroll in this study only after a Pfizer sponsored pharmacokinetic study confirms the proposed dosage corresponding to this age group is appropriate.
- Patients with confirmed Candida infection of the blood, body tissues, or the esophagus.
- Patient's doctor feels voriconazole is an appropriate choice of therapy.
Key exclusion criteria (8 listed)
- A known allergy to voriconazole or to azole to antifungal drugs.
- Females who are pregnant, lactating (breast feeding) or planning a pregnancy during the course of the study, or who are of childbearing potential and not using highly effective method of birth control.
- A patient who is receiving treatment with a drug know to interfere with the heart's electrical system (QTc prolongation).
- A patient who is receiving treatment with a drug that is not permitted to be used with voriconazole.
- For primary therapy: a patient who has received more than 48 hours of antifungal therapy for the current episode of Candida infection.
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 |
|---|---|---|
| voriconazoleAlso: VfendSubjects 12 - <18 yrs (excluding subjects 12 - 14 yrs weighing <50kg): For IC, the loading dose is 6 mg/kg IV q12h on Day 1, followed by 4 mg/kg IV q12h thereafter. Oral therapy, if given, will be administered at a dose of 200 mg q12h. For EC, no loading dose is required, and subjects will be initiated on 3 mg/kg IV q12h. Oral therapy, if given, will be administered at a dose of 200 mg q12h. Subjects 2 - <12 yrs, and subjects 12 - 14 weighing <50kg: For IC, the loading dose is 9 mg/kg IV q12h on Day 1, followed by 8 mg/kg IV q12h thereafter. For EC, no loading dose is required, and subjects will be initiated on 4 mg/kg IV q12. Oral therapy, if given, will be administered at a dose of 9 mg/kg q12h (maximum initial dose of 300 mg). Subjects will be treated for a minimum of 14 days for invasive candidiasis/candidemia or a minimum of 7 days for esophageal candidiasis. Subjects will be treated for up to a maximum of 42 days. | Drug | Active voriconazole |
Primary outcome
Percentage of Participants With Adverse Events - Overall Summary
Time frame: Baseline up to 1 month follow-up
Percentage of participants with adverse events (AEs), serious adverse events (SAEs), severe AEs, who discontinued due to AEs, or who had dose redued or temporarily discontinued due to AEs.
3 secondary outcomes
Percentage of Participants With a Global Response of Success at End of Treatment (EOT)
Time frame: EOT (from 7 to 42 days of treatment)
All-Cause Mortality - Number of Participant Deaths
Time frame: Day 28 and 1 Month Follow-up
Time to Death
Time frame: Baseline up to 1 month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2016.
- 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.
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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
14 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 Candidiasis, run by Pfizer at 14 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 3 inclusion and 8 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 23 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Hong Kong, Hungary, China, Philippines, 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 17 Aug 2015). 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?
Percentage of Participants With Adverse Events - Overall Summary (time frame: Baseline up to 1 month follow-up). 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 NCT01092832, 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 23 Jun 2016.