Invasive CandidiasisPhase 1NCT01666769
Pharmacokinetics of Micafungin in Children on Extracorporeal Membrane Oxygenation
A Phase 1 study testing Micafungin in people with Invasive Candidiasis, run by Kevin Watt at 1 site in United States.
Trial summary
Determine proper dosing of micafungin in children supported with extracorporeal membrane oxygenation (ECMO). Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- 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
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to 9 Feb 2016
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- <= 17.85 years at the time of enrollment.
- Sufficient venous access to permit administration of study medication.
- Supported with either venoarterial (VA) or venovenous (VV) ECMO.
- Availability and willingness of the parent/legal guardian to provide written informed consent.
- For treatment dosing arm: confirmed or suspected infection
Who cannot join
- Subject with a history of anaphylaxis attributed to an echinocandin.
- Any other concomitant condition, which in the opinion of the investigator would preclude a subject's participation in the study.
- Previous participation in this study.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Safety and Pharmacokinetics of Micafungin in Children Supported With Extracorporeal Membrane Oxygenation
Determine proper dosing of micafungin in children supported with extracorporeal membrane oxygenation (ECMO).
Read the detailed description
Extracorporeal membrane oxygenation (ECMO) is a cardiopulmonary bypass device that provides life-saving, complete respiratory and cardiac support for children who suffer refractory heart or lung failure. While on ECMO, children are at increased risk of infection, including fungal infection. Antifungal prophylaxis can potentially reduce the burden of disease in children on ECMO. Because fungal infections can result in biofilms that are difficult to treat, treatment includes not only antifungal medications but also removal of any large intravenous lines. However, catheter removal for children on ECMO is impossible; therefore, therapy relies upon optimal antifungal management alone.
Micafungin is an antifungal medication that works well against the most common fungal infections and has been shown to be safe in children. Micafungin may be particularly efficacious in children on ECMO because of the drug's ability to penetrate biofilms. However, the ECMO circuit is known to substantially alter drug levels for many drugs, resulting in important dosing changes. Appropriate micafungin dosing in this setting is unknown and sub-optimal dosing might result in therapeutic and prophylactic failure.
Standard dosing of micafungin are 4 and 2 mg per kilogram of body weight given intravenously once daily for treatment and prophylaxis, respectively. Based on preliminary data and modeling from other studies, investigators hypothesize that 8 and 4 mg per kilogram given once daily will achieve proper drug levels to respectively treat and prevent fungal infections in children under 2 years of age who are supported by ECMO. Because the ECMO circuit should have less of an impact on volume of distribution in larger children, investigators hypothesize that in children from 2 to 18 years old, standard dosing of micafungin will achieve proper drug concentrations.
Investigators hold the FDA investigational new drug application (IND #115255) to give micafungin to children on ECMO at the doses described above. Blood samples will be collected at specific times around the first and fourth micafungin doses to describe the pharmacokinetics and drug extraction by the ECMO circuit.
- Conditions
- Invasive Candidiasis
- Being tested
- Micafungin
- Keywords
- Extracorporeal membrane oxygenation, ECMO, Extracorporeal life support, Micafungin, Mycamine, Pharmacokinetics
- Medical subject headings
- Candidiasis, Invasive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicafunginDrug
Also called Mycamine
4 mg/kg/day
MicafunginDrug
Also called Mycamine
8 mg/kg/day
MicafunginDrug
Also called Mycamine
Standard of care Dosing
| Study group | Role | What they receive |
|---|---|---|
| Treatment Dosing | Other | Age group: 0 - <2y, Micafungin 8 mg/kg/day IV Receives: Drug: Micafungin |
| Prophylaxis dosing | Other | Age group: 0-<2y, Micafungin 4 mg/kg/day IV Receives: Drug: Micafungin |
| Standard of care Dosing | Other | Age group: 2-17.85 y, Micafungin standard of care dosing (decided by treating physician) Receives: Drug: Micafungin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic primary endpoints
Clearance rate (CL), Volume of distribution (V), Oxygenator extraction efficacy
Measured: Around the first and fourth doses of micafungin: 0-4h prior to and 0-30 min, 60-90 min, 2-4h, 8-10h, 12-16h, 22-24h after infusion of study drug
Secondary outcomes (1)
Safety
Number of adverse events (any untoward medical occurrence in humans, whether or not considered drug-related, which occurs during the conduct of a clinical trial)
Measured: From Dose 1 until 7 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2012 (estimated)
- Study startJan 2013
- Primary completion2 Feb 2016
- Study completion9 Feb 2016
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kevin Watt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kevin Watt, Duke University
- Investigators
- Kevin Watt, MD, Principal investigator, Duke Clinical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01666769
- Sponsor's protocol ID
- Pro00039552
- Status last verified
- Nov 2019
- First submitted
- 14 Aug 2012
- Last updated
- 5 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Pharmacokinetics of Micafungin in Children Supported With Extracorporeal Membrane Oxygenation
- ClinicalTrials.gov ID
- NCT01666769
- Acronym / sponsor ID
- Pro00039552
- Conditions
- Invasive Candidiasis
- Keywords
- Extracorporeal membrane oxygenation, ECMO, Extracorporeal life support, Micafungin, Mycamine, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Kevin WattUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- 2 Feb 2016 (actual)
- Study completion
- 9 Feb 2016 (actual)
- First posted
- 16 Aug 2012 (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.
Determine proper dosing of micafungin in children supported with extracorporeal membrane oxygenation (ECMO).
Detailed description
Extracorporeal membrane oxygenation (ECMO) is a cardiopulmonary bypass device that provides life-saving, complete respiratory and cardiac support for children who suffer refractory heart or lung failure. While on ECMO, children are at increased risk of infection, including fungal infection. Antifungal prophylaxis can potentially reduce the burden of disease in children on ECMO. Because fungal infections can result in biofilms that are difficult to treat, treatment includes not only antifungal medications but also removal of any large intravenous lines. However, catheter removal for children on ECMO is impossible; therefore, therapy relies upon optimal antifungal management alone.
Micafungin is an antifungal medication that works well against the most common fungal infections and has been shown to be safe in children. Micafungin may be particularly efficacious in children on ECMO because of the drug's ability to penetrate biofilms. However, the ECMO circuit is known to substantially alter drug levels for many drugs, resulting in important dosing changes. Appropriate micafungin dosing in this setting is unknown and sub-optimal dosing might result in therapeutic and prophylactic failure.
Standard dosing of micafungin are 4 and 2 mg per kilogram of body weight given intravenously once daily for treatment and prophylaxis, respectively. Based on preliminary data and modeling from other studies, investigators hypothesize that 8 and 4 mg per kilogram given once daily will achieve proper drug levels to respectively treat and prevent fungal infections in children under 2 years of age who are supported by ECMO. Because the ECMO circuit should have less of an impact on volume of distribution in larger children, investigators hypothesize that in children from 2 to 18 years old, standard dosing of micafungin will achieve proper drug concentrations.
Investigators hold the FDA investigational new drug application (IND #115255) to give micafungin to children on ECMO at the doses described above. Blood samples will be collected at specific times around the first and fourth micafungin doses to describe the pharmacokinetics and drug extraction by the ECMO circuit.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment Dosing | Other | Drug: MicafunginAge group: 0 - <2y, Micafungin 8 mg/kg/day IV |
| Prophylaxis dosing | Other | Drug: MicafunginAge group: 0-<2y, Micafungin 4 mg/kg/day IV |
| Standard of care Dosing | Other | Drug: MicafunginAge group: 2-17.85 y, Micafungin standard of care dosing (decided by treating physician) |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- <= 17.85 years at the time of enrollment.
- Sufficient venous access to permit administration of study medication.
- Supported with either venoarterial (VA) or venovenous (VV) ECMO.
- Availability and willingness of the parent/legal guardian to provide written informed consent.
- For treatment dosing arm: confirmed or suspected infection
Key exclusion criteria (4 listed)
- Subject with a history of anaphylaxis attributed to an echinocandin.
- Any other concomitant condition, which in the opinion of the investigator would preclude a subject's participation in the study.
- Previous participation in this study.
- Pregnancy
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: Mycamine4 mg/kg/day | Drug | Prophylaxis dosing |
| MicafunginAlso: Mycamine8 mg/kg/day | Drug | Treatment Dosing |
| MicafunginAlso: MycamineStandard of care Dosing | Drug | Standard of care Dosing |
Primary outcome
Pharmacokinetic primary endpoints
Time frame: Around the first and fourth doses of micafungin: 0-4h prior to and 0-30 min, 60-90 min, 2-4h, 8-10h, 12-16h, 22-24h after infusion of study drug
Clearance rate (CL), Volume of distribution (V), Oxygenator extraction efficacy
1 secondary outcome
Safety
Time frame: From Dose 1 until 7 days after the last dose
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 5 Nov 2019.
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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.
Kevin Watt, MD principal investigator
Duke Clinical Research Institute
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 Micafungin in people with Invasive Candidiasis, run by Kevin Watt 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 5 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 5 Nov 2019. 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?
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?
Pharmacokinetic primary endpoints (time frame: Around the first and fourth doses of micafungin: 0-4h prior to and 0-30 min, 60-90 min, 2-4h, 8-10h, 12-16h, 22-24h after infusion of study drug). 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 5 Nov 2019.