Invasive Fungal InfectionsPhase 1NCT00734500
Anidulafungin PK in Infants and Toddlers
A Phase 1 study testing Anidulafungin in people with Invasive Fungal Infections, run by Michael Cohen-Wolkowiez at 1 site in United States.
Trial summary
This is a prospective, open-label, single center, pharmacokinetic study of anidulafungin in infants and toddlers less than 24 months of age with suspected serious infection. There will be up to 24 subjects enrolled; each will receive anidulafungin. Read more about this study
- Who is it for?
- Ages 48 hours to 24 months
- Conditions the study is for
- Invasive Fungal Infections
- What is being tested?
- Anidulafungin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Jun 2010
- Phase
- Phase 1
- 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 48 hours to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age < 24 months at the time of enrollment
- Patient must have sufficient venous access to permit administration of study medication
- Infant or toddler suspected to have a serious infection and from whom a blood culture has been obtained with 48 hours of study entry
- Availability and willingness of the parent/legally authorized representative to provide written informed consent.
Who cannot join
- Patients with a history of anaphylaxis attributed to an echinocandin
- Any other concomitant condition, which in the opinion of the investigator would preclude a patient's participation in the study
- Previous participation in this study
- Previous exposure to an echinocandin in the month prior to study.
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective, open-label, single center, pharmacokinetic study of anidulafungin in infants and toddlers less than 24 months of age with suspected serious infection. There will be up to 24 subjects enrolled; each will receive anidulafungin. Patients will receive anidulafungin 3 mg/kg loading dose on day 1 of study and will receive 1.5 mg/kg every 24 hours on study days 2-5.Plasma pharmacokinetics will be evaluated using a limited sampling scheme. We hypothesize that the PK parameters of anidulafungin will not differ from those observed in older children and adults.
- Conditions
- Invasive Fungal Infections
- Being tested
- Anidulafungin
- Medical subject headings
- Invasive Fungal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnidulafunginDrug
Also called Eraxis
Intravenous form. Loading Dose: 3 mg/kg/dose. Maintenance dose: 1.5 mg/kg/dose. Treatment duration: 5 days total.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Treatment Receives: Drug: Anidulafungin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Pharmacokinetics (Area Under the Curve) of Anidulafungin in Infants and Toddlers Less Than 24 Months of Age With Suspected Serious Infection.
Area under the curve at steady state
Measured: 5 days
Secondary outcomes (1)
Safety (Participants With Adverse Events) of Anidulafungin in Infants and Toddlers Less Than 24 Months of Age With Suspected Serious Infection.
Participants with Adverse events were collected during the study drug administration phase up to 10 days after last dose of study drug.
Measured: During and up to 10 days after last dose of study drug.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2008 (estimated)
- Study startJan 2008
- Primary completionJun 2010
- Study completionJun 2010
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.
- Other trials for Invasive Fungal InfectionsStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael Cohen-Wolkowiez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michael Cohen-Wolkowiez, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00734500
- Sponsor's protocol ID
- Pro00000637
- Status last verified
- Nov 2012
- First submitted
- 13 Aug 2008
- Last updated
- 21 Nov 2012
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anidulafungin PK in Infants and Toddlers
- ClinicalTrials.gov ID
- NCT00734500
- Acronym / sponsor ID
- Pro00000637
- Conditions
- Invasive Fungal Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Michael Cohen-WolkowiezUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 14 Aug 2008 (estimated)
- Results
- Posted 14 Dec 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, open-label, single center, pharmacokinetic study of anidulafungin in infants and toddlers less than 24 months of age with suspected serious infection. There will be up to 24 subjects enrolled; each will receive anidulafungin. Patients will receive anidulafungin 3 mg/kg loading dose on day 1 of study and will receive 1.5 mg/kg every 24 hours on study days 2-5.Plasma pharmacokinetics will be evaluated using a limited sampling scheme. We hypothesize that the PK parameters of anidulafungin will not differ from those observed in older children and adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: AnidulafunginTreatment |
Who may qualify
- Ages
- 48 hours to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age < 24 months at the time of enrollment
- Patient must have sufficient venous access to permit administration of study medication
- Infant or toddler suspected to have a serious infection and from whom a blood culture has been obtained with 48 hours of study entry
- Availability and willingness of the parent/legally authorized representative to provide written informed consent.
Key exclusion criteria (4 listed)
- Patients with a history of anaphylaxis attributed to an echinocandin
- Any other concomitant condition, which in the opinion of the investigator would preclude a patient's participation in the study
- Previous participation in this study
- Previous exposure to an echinocandin in the month prior to study.
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 |
|---|---|---|
| AnidulafunginAlso: EraxisIntravenous form. Loading Dose: 3 mg/kg/dose. Maintenance dose: 1.5 mg/kg/dose. Treatment duration: 5 days total. | Drug | Treatment |
Primary outcome
The Pharmacokinetics (Area Under the Curve) of Anidulafungin in Infants and Toddlers Less Than 24 Months of Age With Suspected Serious Infection.
Time frame: 5 days
Area under the curve at steady state
1 secondary outcome
Safety (Participants With Adverse Events) of Anidulafungin in Infants and Toddlers Less Than 24 Months of Age With Suspected Serious Infection.
Time frame: During and up to 10 days after last dose of study drug.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Anidulafungin in people with Invasive Fungal Infections, run by Michael Cohen-Wolkowiez at 1 site 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 4 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 21 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 14 Dec 2011). 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?
The Pharmacokinetics (Area Under the Curve) of Anidulafungin in Infants and Toddlers Less Than 24 Months of Age With Suspected Serious Infection. (time frame: 5 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 21 Nov 2012.