Oropharyngeal CandidiasisPhase 1NCT00608335
Study of Mycamine® in Children With Fungal Infections to Evaluate Safety and Blood Levels of the Drug
A Phase 1 study testing Micafungin in people with Oropharyngeal Candidiasis and Candidemia, run by Astellas Pharma Inc at 13 sites in 2 countries.
Trial summary
Children with fungal infections will be divided into two groups by weight. Children weighing < 25 kg will receive a higher dose of study medication (per kg body weight) for 10 to 14 days than children weighing > 25 kg. Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- Oropharyngeal Candidiasis, Candidemia, Invasive Candidiasis
- What is being tested?
- Micafungin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 14 Oct 2007to 8 Sep 2011
- Phase
- Phase 1
- 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 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subject is 2 to 16 years inclusive
- Subject has suspected, proven or probable candidiasis, candidemia or other invasive candidiasis
- Subject has sufficient venous access to permit administration of study medication, collection of pharmacokinetic samples, and monitoring of laboratory safety variables
Who cannot join
- Subject has evidence of significant liver disease, as defined by aspartate transaminase (AST), alanine transaminase (ALT), bilirubin or alkaline phosphatase > 5 times the upper limit of normal (ULN)
- Subject has a concomitant medical condition that in the opinion of the investigator and/or medical monitor precludes enrollment into the study
- Subject has a history of anaphylaxis, hypersensitivity, or any serious reaction to the echinocandin class of antifungals
- Subject has received treatment with an echinocandin within one week prior to first dosing
- Subject status is unstable and subject is unlikely to complete all study required procedures
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States7 sites
University of Texas Southwestern
Dallas, Texas, 75390
Duke University Medical Center
Durham, North Carolina, 27710
Texas Children's Hospital
Houston, Texas, 77030
Children's Mercy Hospital
Kansas City, Missouri, 64108
University of California Los Angeles Medical Center
Los Angeles, California, 90095
Children's Hospital of Orange County
Orange, California, 92868
Oregon Health and Science University
Portland, Oregon, 97239
South Africa6 sites
Benmed Park Clinic
Benoni, 1500
Grootte Schuur Hospital
Cape Town, 7924
GCT -Sunnyside Medi-clinic
Lynn East, 0039
St. Mary's Hospital
Mariannhill, 3610
Jubilee Hospital
Themba, 0400
2 Military Hospital
Wynberg, 7824
About this study
Official title: A Phase 1, Open-Label Study Of The Safety And Pharmacokinetics Of Repeated-Dose Micafungin (FK463) In Children (2-5 Years AND 6-11 Years) And Adolescents (12-16 Years) With Esophageal Candidiasis Or Other Invasive Candidiasis
Children with fungal infections will be divided into two groups by weight. Children weighing < 25 kg will receive a higher dose of study medication (per kg body weight) for 10 to 14 days than children weighing > 25 kg.
Read the detailed description
This is a prospective, multicenter, open-label, repeat-dose study conducted in two groups. Subjects in Group 1 and Group 2 will receive treatment for 10 to 14 days (per investigator clinical judgment); dose level (3.0 mg/kg or 4.5 mg/kg) will be determined by the subject's weight at baseline. Study procedures in both groups will be similar except that serial blood samples for assessment of pharmacokinetics will be collected in Group 1. Subjects may only participate in one group of the study.
At least 24 subjects, with at least 8 in each of three age ranges, will be enrolled in Group 1 (PK + safety). At least 36 subjects will be enrolled in Group 2 (safety), with at least 12 in each of the three age ranges.
- Being tested
- Micafungin
- Keywords
- Antifungal, Micafungin, Echinocandin, Candidiasis
- Medical subject headings
- Candidemia, Candidiasis, Invasive, Candidiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicafunginDrug
Also called FK463
IV
| Study group | Role | What they receive |
|---|---|---|
| 1. Micafungin 3.0 mg | Experimental | IV Receives: Drug: Micafungin |
| 2. Micafungin 4.5 mg | Experimental | IV Receives: Drug: Micafungin |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK parameters (AUCtau, Tmax, and Cmax)
Measured: 10 - 14 Days
Secondary outcomes (4)
Adverse events
Measured: Day 1 to End of Study
Vital signs
Measured: Day 1 to End of Study
Hematology and chemistry laboratory tests
Measured: Day 1 to End of Study
12-lead ECGs and Physical examination
Measured: Day 1 to End of Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2008 (estimated)
- Study start14 Oct 2007
- Primary completion8 Sep 2011
- Study completion8 Sep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oropharyngeal CandidiasisStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Senior Medical Director, Study director, Astellas Pharma Global Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00608335
- Sponsor's protocol ID
- 9463-CL-2101
- Status last verified
- Nov 2024
- First submitted
- 23 Jan 2008
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label Study Of The Safety And Pharmacokinetics Of Repeated-Dose Micafungin (FK463) In Children (2-5 Years AND 6-11 Years) And Adolescents (12-16 Years) With Esophageal Candidiasis Or Other Invasive Candidiasis
- ClinicalTrials.gov ID
- NCT00608335
- Acronym / sponsor ID
- 9463-CL-2101
- Keywords
- Antifungal, Micafungin, Echinocandin, Candidiasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 14 Oct 2007 (actual)
- Primary completion
- 8 Sep 2011 (actual)
- Study completion
- 8 Sep 2011 (actual)
- First posted
- 6 Feb 2008 (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.
Children with fungal infections will be divided into two groups by weight. Children weighing < 25 kg will receive a higher dose of study medication (per kg body weight) for 10 to 14 days than children weighing > 25 kg.
Detailed description
This is a prospective, multicenter, open-label, repeat-dose study conducted in two groups. Subjects in Group 1 and Group 2 will receive treatment for 10 to 14 days (per investigator clinical judgment); dose level (3.0 mg/kg or 4.5 mg/kg) will be determined by the subject's weight at baseline. Study procedures in both groups will be similar except that serial blood samples for assessment of pharmacokinetics will be collected in Group 1. Subjects may only participate in one group of the study.
At least 24 subjects, with at least 8 in each of three age ranges, will be enrolled in Group 1 (PK + safety). At least 36 subjects will be enrolled in Group 2 (safety), with at least 12 in each of the three age ranges.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. Micafungin 3.0 mg | Experimental | Drug: MicafunginIV |
| 2. Micafungin 4.5 mg | Experimental | Drug: MicafunginIV |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Subject is 2 to 16 years inclusive
- Subject has suspected, proven or probable candidiasis, candidemia or other invasive candidiasis
- Subject has sufficient venous access to permit administration of study medication, collection of pharmacokinetic samples, and monitoring of laboratory safety variables
Key exclusion criteria (5 listed)
- Subject has evidence of significant liver disease, as defined by aspartate transaminase (AST), alanine transaminase (ALT), bilirubin or alkaline phosphatase > 5 times the upper limit of normal (ULN)
- Subject has a concomitant medical condition that in the opinion of the investigator and/or medical monitor precludes enrollment into the study
- Subject has a history of anaphylaxis, hypersensitivity, or any serious reaction to the echinocandin class of antifungals
- Subject has received treatment with an echinocandin within one week prior to first dosing
- Subject status is unstable and subject is unlikely to complete all study required procedures
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 |
|---|---|---|
| MicafunginAlso: FK463IV | Drug | 1. Micafungin 3.0 mg, 2. Micafungin 4.5 mg |
Primary outcome
PK parameters (AUCtau, Tmax, and Cmax)
Time frame: 10 - 14 Days
4 secondary outcomes
Adverse events
Time frame: Day 1 to End of Study
Vital signs
Time frame: Day 1 to End of Study
Hematology and chemistry laboratory tests
Time frame: Day 1 to End of Study
12-lead ECGs and Physical examination
Time frame: Day 1 to End of Study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Individual participant dataSharing planned: Yes. Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Related trials for Oropharyngeal Candidiasis
RecruitingObservational study
Oropharyngeal Candidiasis (OPC) and S-ECC
Candida Infection, Oral Thrush
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.
Senior Medical Director study director
Astellas Pharma Global Development
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Micafungin in people with Oropharyngeal Candidiasis and Candidemia, run by Astellas Pharma Inc at 13 sites in 2 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 5 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: finished, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, South Africa. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
PK parameters (AUCtau, Tmax, and Cmax) (time frame: 10 - 14 Days). 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 18 Nov 2024.