CandidaPhase 1NCT00818584
An Open-Label Study of the Safety and Pharmacokinetics of Repeated-Dose Micafungin in Neonates
A Phase 1 study testing Micafungin in people with Candida, run by Astellas Pharma Inc at 7 sites in United States.
Trial summary
This study will evaluate pharmacokinetics and safety of intravenous micafungin in neonates with suspected candida infection Read more about this study
- Who is it for?
- Ages 48 hours to 120 days
- Conditions the study is for
- Candida
- 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
- 13 participants
- Where
- 7 sitesUnited States
- Study dates
- Aug 2007to Oct 2007
- 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 48 hours to 120 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Informed consent and HIPAA authorization of the infant's parent or legally authorized representative must be obtained prior to study entry
- Infant has sufficient venous access to permit study drug dosing
- Infant is suspected to have a systemic Candida infection and appropriate cultures (blood with or without urine/CSF) are obtained at the time of study entry
Who cannot join
- Infant has a history of anaphylaxis, hypersensitivity, or any serious reaction to the echinocandin class of antifungals
- Infant has received an echinocandin within one month prior to study entry
- Infant has a concomitant medical condition which, in the opinion of the investigator and/or medical advisor, may create an unacceptable additional risk
- Infant has a life expectancy of less than 96 hours
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Study site
Birmingham, Alabama, 35233
Study site
Charlottesville, Virginia, 22908
Study site
Dallas, Texas, 75390
Study site
Durham, North Carolina, 27710
Study site
Kansas City, Missouri, 64108
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 in Neonates
This study will evaluate pharmacokinetics and safety of intravenous micafungin in neonates with suspected candida infection
Read the detailed description
Subjects will be stratified by weight to receive one of two doses of study drug
- Conditions
- Candida
- Being tested
- Micafungin
- Keywords
- Micafungin, Candida, Neonates, Mycamine, FK463
- Medical subject headings
- Torulopsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicafunginDrug
Also called Mycamine, FK463
IV Administration
| Study group | Role | What they receive |
|---|---|---|
| 1. micafungin lower dose | Experimental | Not described Receives: Drug: Micafungin |
| 2. micafungin higher dose | Experimental | Not described Receives: Drug: Micafungin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of micafungin plasma pharmacokinetic parameters
Measured: Day 4
Secondary outcomes (1)
Monitor adverse events
Measured: 11 or 12 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2009 (estimated)
- Study startAug 2007
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CandidaStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Use Central Contact, Study director, Astellas Pharma US, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00818584
- Sponsor's protocol ID
- 9463-CL-2104
- Status last verified
- Mar 2013
- First submitted
- 6 Jan 2009
- Last updated
- 6 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Benjamin DK Jr, Smith PB, Arrieta A, Castro L, Sanchez PJ, Kaufman D, Arnold LJ, Kovanda LL, Sawamoto T, Buell DN, Hope WW, Walsh TJ. Safety and pharmacokinetics of repeat-dose micafungin in young infants. Clin Pharmacol Ther. 2010 Jan;87(1):93-9. doi: 10.1038/clpt.2009.200. Epub 2009 Nov 4.
PubMed 19890251
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2013. 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 in Neonates
- ClinicalTrials.gov ID
- NCT00818584
- Acronym / sponsor ID
- 9463-CL-2104
- Conditions
- Candida
- Keywords
- Micafungin, Candida, Neonates, Mycamine, FK463
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 7 Jan 2009 (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 will evaluate pharmacokinetics and safety of intravenous micafungin in neonates with suspected candida infection
Detailed description
Subjects will be stratified by weight to receive one of two doses of study drug
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. micafungin lower dose | Experimental | Drug: Micafungin |
| 2. micafungin higher dose | Experimental | Drug: Micafungin |
Who may qualify
- Ages
- 48 hours to 120 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Informed consent and HIPAA authorization of the infant's parent or legally authorized representative must be obtained prior to study entry
- Infant has sufficient venous access to permit study drug dosing
- Infant is suspected to have a systemic Candida infection and appropriate cultures (blood with or without urine/CSF) are obtained at the time of study entry
Key exclusion criteria (4 listed)
- Infant has a history of anaphylaxis, hypersensitivity, or any serious reaction to the echinocandin class of antifungals
- Infant has received an echinocandin within one month prior to study entry
- Infant has a concomitant medical condition which, in the opinion of the investigator and/or medical advisor, may create an unacceptable additional risk
- Infant has a life expectancy of less than 96 hours
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: Mycamine, FK463IV Administration | Drug | 1. micafungin lower dose, 2. micafungin higher dose |
Primary outcome
Assessment of micafungin plasma pharmacokinetic parameters
Time frame: Day 4
1 secondary outcome
Monitor adverse events
Time frame: 11 or 12 Days
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 6 Mar 2013.
- Background: PubMed 19890251Benjamin DK Jr, Smith PB, Arrieta A, Castro L, Sanchez PJ, Kaufman D, Arnold LJ, Kovanda LL, Sawamoto T, Buell DN, Hope WW, Walsh TJ. Safety and pharmacokinetics of repeat-dose micafungin in young infants. Clin Pharmacol Ther. 2010 Jan;87(1):93-9. doi: 10.1038/clpt.2009.200. Epub 2009 Nov 4.
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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.
Use Central Contact study director
Astellas Pharma US, Inc.
7 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 in people with Candida, run by Astellas Pharma Inc at 7 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 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: finished, as of the sponsor's last update on 6 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Assessment of micafungin plasma pharmacokinetic parameters (time frame: Day 4). 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 NCT00818584, 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 6 Mar 2013.