Invasive CandidiasisPhase 1NCT00607763
Study of Mycamine® in Infants and Toddlers With Fungal Infections to Evaluate Safety and Blood Levels of the Drug
A Phase 1 study testing Micafungin (Mycamine) in people with Invasive Candidiasis and Esophageal Candidiasis, run by Astellas Pharma Inc at 6 sites in United States.
Trial summary
Infants and toddlers with fungal infections will receive 10 to 14 days of treatment with an antifungal drug. Safety and drug blood levels will be assessed Read more about this study
- Who is it for?
- Ages 4 to 23 months
- Conditions the study is for
- Invasive Candidiasis, Esophageal Candidiasis, Oropharyngeal Candidiasis
- What is being tested?
- Micafungin (Mycamine)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 6 sitesUnited States
- Study dates
- Oct 2007to Oct 2009
- 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 4 to 23 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subject is ≥4 months to < 24 months
- 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
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Study site
Dallas, Texas, 75390
Study site
Houston, Texas, 77030
Study site
Kansas City, Missouri, 64108
Study site
Los Angeles, California, 90095
Study site
Louisville, Kentucky, 40202
Study site
Orange, California, 92868
About this study
Official title: A Phase 1, Open-Label Study Of The Safety And Pharmacokinetics Of Repeated-Dose Micafungin (FK463) In Infants And Toddlers (≥4 Months TO < 24 Months Of Age) With Esophageal Candidiasis Or Other Invasive Candidiasis
Infants and toddlers with fungal infections will receive 10 to 14 days of treatment with an antifungal drug. Safety and drug blood levels will be assessed
Read the detailed description
This is a prospective, multicenter, open-label, repeat-dose study. Subjects will receive treatment with intravenous micafungin for 10 to 14 days (per investigator clinical judgment) at a daily dose of 4.5 mg/kg (determined by the subject's weight at baseline). Serial blood samples for assessment of pharmacokinetics will be collected.
- Being tested
- Micafungin (Mycamine)
- Keywords
- Antifungal, Echinocandin, Candidiasis, Micafungin
- Medical subject headings
- Candidiasis, Invasive, Candidemia, Candidiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micafungin (Mycamine)Drug
Also called FK463
IV
| Study group | Role | What they receive |
|---|---|---|
| 1. Micafungin | Experimental | Not described Receives: Drug: Micafungin (Mycamine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Micafungin pharmacokinetics
Measured: 10 - 14 Days
Secondary outcomes (1)
Assess safety and tolerability of micafungin by adverse events, vital signs, hematology and chemistry laboratory tests, ECGs and physical evaluation
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 startOct 2007
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Central Contact, Study director, Astellas Pharma Global Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00607763
- Sponsor's protocol ID
- 9463-CL-2102
- Status last verified
- Aug 2014
- First submitted
- 23 Jan 2008
- Last updated
- 20 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2014. 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 Infants And Toddlers (≥4 Months TO < 24 Months Of Age) With Esophageal Candidiasis Or Other Invasive Candidiasis
- ClinicalTrials.gov ID
- NCT00607763
- Acronym / sponsor ID
- 9463-CL-2102
- Keywords
- Antifungal, Echinocandin, Candidiasis, Micafungin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (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.
Infants and toddlers with fungal infections will receive 10 to 14 days of treatment with an antifungal drug. Safety and drug blood levels will be assessed
Detailed description
This is a prospective, multicenter, open-label, repeat-dose study. Subjects will receive treatment with intravenous micafungin for 10 to 14 days (per investigator clinical judgment) at a daily dose of 4.5 mg/kg (determined by the subject's weight at baseline). Serial blood samples for assessment of pharmacokinetics will be collected.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1. Micafungin | Experimental | Drug: Micafungin (Mycamine) |
Who may qualify
- Ages
- 4 to 23 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Subject is ≥4 months to < 24 months
- 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 |
|---|---|---|
| Micafungin (Mycamine)Also: FK463IV | Drug | 1. Micafungin |
Primary outcome
Evaluation of Micafungin pharmacokinetics
Time frame: 10 - 14 Days
1 secondary outcome
Assess safety and tolerability of micafungin by adverse events, vital signs, hematology and chemistry laboratory tests, ECGs and physical evaluation
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 20 Aug 2014.
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Middle East Study of Infections in Patients With Hematological Malignancies
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Comparison of Uncomplicated Candidemia Therapy Duration in Children and Adults
Invasive Candidiasis
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A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Participants With Candidemia and/or Invasive Candidiasis.
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Shortening Treatment Duration in Uncomplicated Candidemia: the CanTEN Trial
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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.
Central Contact study director
Astellas Pharma Global Development
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Micafungin (Mycamine) in people with Invasive Candidiasis and Esophageal Candidiasis, run by Astellas Pharma Inc at 6 sites in United States.
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 20 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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?
Evaluation of Micafungin pharmacokinetics (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 20 Aug 2014.