Cardiopulmonary ArrestPhase 1NCT01169402
Pharmacokinetics/Pharmacodynamics (PK/PD) of Fluconazole in Children on Extracorporeal Membrane Oxygenation (ECMO)
A Phase 1 study testing Fluconazole in people with Cardiopulmonary Arrest and Fungal Infection, run by Michael Cohen-Wolkowiez at 1 site in United States.
Trial summary
Extracorporeal membrane oxygenation (ECMO) is a form of heart-lung bypass used to support children who suffer heart or lung failure until whatever illness caused that failure can be treated and reversed. While on ECMO, children are at increased risk of infection, including fungal infection. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Cardiopulmonary Arrest, Fungal Infection
- What is being tested?
- Fluconazole
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to 20 Feb 2013
- 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
- <= 17.5 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.
Who cannot join
- Subject with a history of anaphylaxis attributed to an azole.
- 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.
- Subjects who are receiving or who have received cyclosporine, tacrolimus, or azithromycin in the 72 hours prior to first dose of study product require protocol chair notification prior to enrollment.
- 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 Fluconazole Prophylaxis in Children Supported With Extracorporeal Membrane Oxygenation
Extracorporeal membrane oxygenation (ECMO) is a form of heart-lung bypass used to support children who suffer heart or lung failure until whatever illness caused that failure can be treated and reversed. While on ECMO, children are at increased risk of infection, including fungal infection. Treatment for fungal infection includes not only antifungal medications but also removal of any large intravenous (IV) lines. Since ECMO requires large IV lines, proper treatment of fungal infections would be difficult if not impossible. The investigators believe that giving prophylactic antifungal medication to all children on ECMO may prevent fungal infections from developing in the first place.
Fluconazole is an antifungal medication that works well against the most common fungal infections and has been shown to be safe in children. Unfortunately, the ECMO machine has the potential to significantly alter the drug levels of medications so the investigators do not know the proper dose of Fluconazole to give children on ECMO. Standard dosing of fluconazole is 12mg per kilogram of body weight given intravenously once daily. Based on preliminary data and modeling from other studies, the investigators think 25mg per kilogram given once weekly will achieve proper drug levels to prevent fungal infections. The investigators have obtained FDA approval to give this dose of fluconazole to children on ECMO who are enrolled in the study. Blood samples will be collected at specific times around the first and second fluconazole doses to describe the PK and drug extraction by the ECMO circuit.
- Conditions
- Cardiopulmonary Arrest, Fungal Infection
- Being tested
- Fluconazole
- Keywords
- extracorporeal membrane oxygenation, ECMO, extracorporeal life support, fluconazole, diflucan, pharmacokinetics, pharmacodynamics
- Medical subject headings
- Heart Arrest, Mycoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluconazoleDrug
Also called Diflucan
25mg/kg intravenously once weekly while on ECMO
| Study group | Role | What they receive |
|---|---|---|
| Fluconazole | Experimental | Not described Receives: Drug: Fluconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics/Pharmacodynamics
Determine proper dosing of fluconazole in children supported with extracorporeal membrane oxygentation
Measured: Quarterly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2010 (estimated)
- Study startJul 2010
- Primary completion20 Feb 2013
- Study completion20 Feb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiopulmonary ArrestStudies 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
- 21 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
- Investigators
- Kevin M Watt, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01169402
- Sponsor's protocol ID
- Pro00022822
- Status last verified
- Nov 2017
- First submitted
- 22 Jul 2010
- Last updated
- 22 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Pharmacokinetics of Fluconazole Prophylaxis in Children Supported With Extracorporeal Membrane Oxygenation
- ClinicalTrials.gov ID
- NCT01169402
- Acronym / sponsor ID
- Pro00022822
- Conditions
- Cardiopulmonary Arrest, Fungal Infection
- Keywords
- extracorporeal membrane oxygenation, ECMO, extracorporeal life support, fluconazole, diflucan, pharmacokinetics, pharmacodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Michael Cohen-WolkowiezUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- 20 Feb 2013 (actual)
- Study completion
- 20 Feb 2013 (actual)
- First posted
- 26 Jul 2010 (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.
Extracorporeal membrane oxygenation (ECMO) is a form of heart-lung bypass used to support children who suffer heart or lung failure until whatever illness caused that failure can be treated and reversed. While on ECMO, children are at increased risk of infection, including fungal infection. Treatment for fungal infection includes not only antifungal medications but also removal of any large intravenous (IV) lines. Since ECMO requires large IV lines, proper treatment of fungal infections would be difficult if not impossible. The investigators believe that giving prophylactic antifungal medication to all children on ECMO may prevent fungal infections from developing in the first place.
Fluconazole is an antifungal medication that works well against the most common fungal infections and has been shown to be safe in children. Unfortunately, the ECMO machine has the potential to significantly alter the drug levels of medications so the investigators do not know the proper dose of Fluconazole to give children on ECMO. Standard dosing of fluconazole is 12mg per kilogram of body weight given intravenously once daily. Based on preliminary data and modeling from other studies, the investigators think 25mg per kilogram given once weekly will achieve proper drug levels to prevent fungal infections. The investigators have obtained FDA approval to give this dose of fluconazole to children on ECMO who are enrolled in the study. Blood samples will be collected at specific times around the first and second fluconazole doses to describe the PK and drug extraction by the ECMO circuit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fluconazole | Experimental | Drug: Fluconazole |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- <= 17.5 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.
Key exclusion criteria (5 listed)
- Subject with a history of anaphylaxis attributed to an azole.
- 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.
- Subjects who are receiving or who have received cyclosporine, tacrolimus, or azithromycin in the 72 hours prior to first dose of study product require protocol chair notification prior to enrollment.
- 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 |
|---|---|---|
| FluconazoleAlso: Diflucan25mg/kg intravenously once weekly while on ECMO | Drug | Fluconazole |
Primary outcome
Pharmacokinetics/Pharmacodynamics
Time frame: Quarterly
Determine proper dosing of fluconazole in children supported with extracorporeal membrane oxygentation
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 22 Nov 2017.
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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 M Watt, MD principal investigator
Duke University
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 Fluconazole in people with Cardiopulmonary Arrest and Fungal Infection, 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 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 22 Nov 2017. 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?
Pharmacokinetics/Pharmacodynamics (time frame: Quarterly). 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 22 Nov 2017.