Fungal InfectionNCT00514358
Fluconazole Pharmacokinetics in Infants
An observational study of Fungal Infection, run by Children's Hospital of Philadelphia at 5 sites in United States.
Trial summary
The purpose of this study is to determine the pharmacokinetics of fluconazole in infants and evaluate the dose exposure relationship of current fluconazole dosing in infants who are receiving fluconazole for the prevention or treatment of systemic fungal infections. Read more about this study
- Who is it for?
- Ages Up to 119 days
- Conditions the study is for
- Fungal Infection
- How many people
- 55 participants
- Where
- 5 sitesUnited States
- Study dates
- Nov 2005to Jun 2007
- Phase
- Observational
- 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 119 days
- All sexes
- No healthy volunteers
- Child
Study population: Premature and term infants less than 90 days of age who are receiving fluconazole as standard of care therapy.
Who may be able to join
- Infant born >23 weeks gestational age with postnatal age <120 days
- Due to receive fluconazole therapy for clinical care
- Permission from attending neonatologist
- Informed consent of parent or legal guardian
Who cannot join
None listed.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Virginia
Charlottesville, Virginia, 22908
Children's Hospital of Michigan, Wayne State University
Detroit, Michigan, 48201
Texas Children's Hospital, Baylor College of Medicine
Houston, Texas, 77030
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
University of Utah
Salt Lake City, Utah, 84132
About this study
Official title: A Multicenter, Open Label Pharmacokinetic Study of Fluconazole in Infants
The purpose of this study is to determine the pharmacokinetics of fluconazole in infants and evaluate the dose exposure relationship of current fluconazole dosing in infants who are receiving fluconazole for the prevention or treatment of systemic fungal infections.
Read the detailed description
Systemic fungal infections in neonates are associated with high morbidity and mortality. The increasing use of intravenous central catheters, parenteral nutrition, and antibiotics in neonatal intensive care units has contributed not only to improved survival but also to the increasing incidence of fungal sepsis particularly in preterm infants. Decreasing fungal colonization can decrease the risk of systemic fungal infection. Fluconazole is a potent antifungal agent in the triazole family. Fluconazole has been shown to reduce the risk of fungal colonization and systemic infection however we do not have sufficient pharmacokinetic information in neonates to support dosing guidelines. In this study, we will perform a population pharmacokinetic study in neonates receiving fluconazole as standard of care. Fluconazole levels will be measured using a liquid chromatography/tandem mass spectroscopy (LC/MS/MS) assay from very small quantities of blood appropriate for neonates. Pharmacokinetic data obtained in this study will support appropriate dosing of fluconazole in neonates and provide information regarding drug metabolism in neonates.
- Conditions
- Fungal Infection
- Keywords
- Fungal, Infection, sepsis, pharmacokinetics
- Medical subject headings
- Mycoses, Infections, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| gestational age | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To develop a population PK model of fluconazole drug disposition in premature infants who are receiving fluconazole for treatment or prophylaxis against systemic fungal infections.
PK blood samples obtained over 3 weeks in infants receiving fluconazole as standard of care
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2007 (estimated)
- Study startNov 2005
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Fungal InfectionStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Pediatric Pharmacology Research Units Network
- Investigators
- Kelly C. Wade, M.D., Ph.D., Principal investigator, Children's Hospital of PhiladelphiaPeter C Adamson, M.D., Principal investigator, Children's Hospital of PhiladelphiaJeffery Barrett, Ph.D., Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00514358
- Sponsor's protocol ID
- PPRU10826
- Status last verified
- Jul 2011
- First submitted
- 8 Aug 2007
- Last updated
- 7 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wade KC, Benjamin DK Jr, Kaufman DA, Ward RM, Smith PB, Jayaraman B, Adamson PC, Gastonguay MR, Barrett JS. Fluconazole dosing for the prevention or treatment of invasive candidiasis in young infants. Pediatr Infect Dis J. 2009 Aug;28(8):717-23. doi: 10.1097/INF.0b013e31819f1f50.
PubMed 19593252Wade KC, Wu D, Kaufman DA, Ward RM, Benjamin DK Jr, Sullivan JE, Ramey N, Jayaraman B, Hoppu K, Adamson PC, Gastonguay MR, Barrett JS; National Institute of Child Health and Development Pediatric Pharmacology Research Unit Network. Population pharmacokinetics of fluconazole in young infants. Antimicrob Agents Chemother. 2008 Nov;52(11):4043-9. doi: 10.1128/AAC.00569-08. Epub 2008 Sep 22.
PubMed 18809946
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open Label Pharmacokinetic Study of Fluconazole in Infants
- ClinicalTrials.gov ID
- NCT00514358
- Acronym / sponsor ID
- PPRU10826
- Conditions
- Fungal Infection
- Keywords
- Fungal, Infection, sepsis, pharmacokinetics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Pediatric Pharmacology Research Units Network
- Study start
- Nov 2005
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 9 Aug 2007 (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.
The purpose of this study is to determine the pharmacokinetics of fluconazole in infants and evaluate the dose exposure relationship of current fluconazole dosing in infants who are receiving fluconazole for the prevention or treatment of systemic fungal infections.
Detailed description
Systemic fungal infections in neonates are associated with high morbidity and mortality. The increasing use of intravenous central catheters, parenteral nutrition, and antibiotics in neonatal intensive care units has contributed not only to improved survival but also to the increasing incidence of fungal sepsis particularly in preterm infants. Decreasing fungal colonization can decrease the risk of systemic fungal infection. Fluconazole is a potent antifungal agent in the triazole family. Fluconazole has been shown to reduce the risk of fungal colonization and systemic infection however we do not have sufficient pharmacokinetic information in neonates to support dosing guidelines. In this study, we will perform a population pharmacokinetic study in neonates receiving fluconazole as standard of care. Fluconazole levels will be measured using a liquid chromatography/tandem mass spectroscopy (LC/MS/MS) assay from very small quantities of blood appropriate for neonates. Pharmacokinetic data obtained in this study will support appropriate dosing of fluconazole in neonates and provide information regarding drug metabolism in neonates.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| gestational age | – | – |
Who may qualify
- Ages
- Up to 119 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Premature and term infants less than 90 days of age who are receiving fluconazole as standard of care therapy.
Key inclusion criteria (4 listed)
- Infant born >23 weeks gestational age with postnatal age <120 days
- Due to receive fluconazole therapy for clinical care
- Permission from attending neonatologist
- Informed consent of parent or legal guardian
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To develop a population PK model of fluconazole drug disposition in premature infants who are receiving fluconazole for treatment or prophylaxis against systemic fungal infections.
Time frame: 3 weeks
PK blood samples obtained over 3 weeks in infants receiving fluconazole as standard of care
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 7 Jul 2011.
- Results publication: PubMed 19593252Wade KC, Benjamin DK Jr, Kaufman DA, Ward RM, Smith PB, Jayaraman B, Adamson PC, Gastonguay MR, Barrett JS. Fluconazole dosing for the prevention or treatment of invasive candidiasis in young infants. Pediatr Infect Dis J. 2009 Aug;28(8):717-23. doi: 10.1097/INF.0b013e31819f1f50.
- Results publication: PubMed 18809946Wade KC, Wu D, Kaufman DA, Ward RM, Benjamin DK Jr, Sullivan JE, Ramey N, Jayaraman B, Hoppu K, Adamson PC, Gastonguay MR, Barrett JS; National Institute of Child Health and Development Pediatric Pharmacology Research Unit Network. Population pharmacokinetics of fluconazole in young infants. Antimicrob Agents Chemother. 2008 Nov;52(11):4043-9. doi: 10.1128/AAC.00569-08. Epub 2008 Sep 22.
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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.
Kelly C. Wade, M.D., Ph.D. principal investigator
Children's Hospital of Philadelphia
Peter C Adamson, M.D. principal investigator
Children's Hospital of Philadelphia
Jeffery Barrett, Ph.D. principal investigator
Children's Hospital of Philadelphia
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fungal Infection, run by Children's Hospital of Philadelphia at 5 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 4 inclusion and 0 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 7 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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.
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?
To develop a population PK model of fluconazole drug disposition in premature infants who are receiving fluconazole for treatment or prophylaxis against systemic fungal infections. (time frame: 3 weeks). 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 NCT00514358, which also lists 2 linked publications.
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 7 Jul 2011.