CandidiasisPhase 1NCT00797420
Pharmacokinetics (PK) Study of a Fluconazole Loading Dose in Infants and Toddlers
A Phase 1 study testing Fluconazole Loading Dose and Fluconazole Loading Dose & High Dose in people with Candidiasis, run by Daniel Benjamin at 1 site in United States.
Trial summary
The purpose of this study is to investigate the pharmacokinetics and safety of a fluconazole loading dose in infants and toddlers. Read more about this study
- Who is it for?
- Ages 48 hours to 2 years
- Conditions the study is for
- Candidiasis
- What is being tested?
- Fluconazole Loading Dose and Fluconazole Loading Dose & High Dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Sep 2011
- 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 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- suspected sepsis with blood culture within 48 hours
- age ≥ 48 hours and < 2 years of age
- sufficient venous access to permit study drug administration
Who cannot join
- allergic reaction to azole
- history of fluconazole administration in prior 5 days
- liver dysfunction
- renal failure
- concomitant use of cyclosporine, tacrolimus, or azithromycin
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Univeristy Medical Center
Durham, North Carolina, 27715
About this study
Official title: Pharmacokinetics of a Fluconazole Loading Dose in Infants and Toddlers
The purpose of this study is to investigate the pharmacokinetics and safety of a fluconazole loading dose in infants and toddlers.
Read the detailed description
This is an open label study to investigative the pharmacokinetics and safety of a fluconazole loading dose in infants and toddlers < 2 years of age with suspected sepsis. There will be two treatment groups: single fluconazole loading dose 25 mg/kg; fluconazole loading dose 25mg/kg followed by 12 mg/kg daily for total of 5 days. There will be three age cohorts within each group: pre-term < 30 week EGA infants > 48 hours and < 31 days; > 30 weeks EGA infants > 48 hours and < 31 days; infants ≥ 31 days and < 2 years of age. The study requires administration of fluconazole over 1-5 days depending on treatment group followed by 1 week of safety monitoring. Six to eight 100 µL PK samples will be obtained over the 5 days of drug administration. The risks are reasonable vs. the benefits and have been minimized appropriately. There may be benefit to the subjects (administration of empirical antifungal therapy), and information from the study may benefit a large number of other infants and toddlers with suspected or proven fungal sepsis. There is a data analysis plan.
- Conditions
- Candidiasis
- Being tested
- Fluconazole Loading Dose, Fluconazole Loading Dose & High Dose
- Keywords
- fluconazole, pharmacokinetic, candidiasis, sepsis, pediatric, infants, antifungal, candidemia, fungemia, loading dose
- Medical subject headings
- Candidiasis, Sepsis, Candidemia, Fungemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluconazole Loading DoseDrug
Also called Diflucan
Single Fluconazole loading dose 25 mg/kg
Fluconazole Loading Dose & High DoseDrug
Also called Diflucan
Fluconazole loading dose 25 mg/kg, followed by fluconazole 12 mg/kg q24 hours for total of 5 days
| Study group | Role | What they receive |
|---|---|---|
| Loading Dose | Other | Loading Dose Receives: Drug: Fluconazole Loading Dose |
| Loading & high dose | Other | Loading dose \& high dose Fluconazole Receives: Drug: Fluconazole Loading Dose & High Dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration of Fluconazole
Measured: 6-8 samples over 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionJan 2010
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daniel Benjamin
- Sponsor type
- University, hospital or other
- Collaborators
- Pediatric Pharmacology Research Units Network
- Responsible party
- Sponsor-investigator, Daniel Benjamin, Duke University
- Investigators
- Daniel Benjamin, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00797420
- Sponsor's protocol ID
- Pro00011454
- Other IDs
- NIH-5U10-HD-045962-04
- Status last verified
- Nov 2018
- First submitted
- 23 Nov 2008
- Last updated
- 5 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Benjamin DK Jr, Stoll BJ. Infection in late preterm infants. Clin Perinatol. 2006 Dec;33(4):871-82; abstract x. doi: 10.1016/j.clp.2006.09.005.
PubMed 17148010Stoll BJ, Hansen N, Fanaroff AA, Wright LL, Carlo WA, Ehrenkranz RA, Lemons JA, Donovan EF, Stark AR, Tyson JE, Oh W, Bauer CR, Korones SB, Shankaran S, Laptook AR, Stevenson DK, Papile LA, Poole WK. Late-onset sepsis in very low birth weight neonates: the experience of the NICHD Neonatal Research Network. Pediatrics. 2002 Aug;110(2 Pt 1):285-91. doi: 10.1542/peds.110.2.285.
PubMed 12165580Benjamin DK Jr, DeLong ER, Steinbach WJ, Cotton CM, Walsh TJ, Clark RH. Empirical therapy for neonatal candidemia in very low birth weight infants. Pediatrics. 2003 Sep;112(3 Pt 1):543-7. doi: 10.1542/peds.112.3.543.
PubMed 12949281Novelli V, Holzel H. Safety and tolerability of fluconazole in children. Antimicrob Agents Chemother. 1999 Aug;43(8):1955-60. doi: 10.1128/AAC.43.8.1955.
PubMed 10428919Brammer KW, Coates PE. Pharmacokinetics of fluconazole in pediatric patients. Eur J Clin Microbiol Infect Dis. 1994 Apr;13(4):325-9. doi: 10.1007/BF01974613.
PubMed 8070441Wade 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 18809946Anaissie EJ, Kontoyiannis DP, Huls C, Vartivarian SE, Karl C, Prince RA, Bosso J, Bodey GP. Safety, plasma concentrations, and efficacy of high-dose fluconazole in invasive mold infections. J Infect Dis. 1995 Aug;172(2):599-602. doi: 10.1093/infdis/172.2.599.
PubMed 7622915
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of a Fluconazole Loading Dose in Infants and Toddlers
- ClinicalTrials.gov ID
- NCT00797420
- Acronym / sponsor ID
- Pro00011454
- Conditions
- Candidiasis
- Keywords
- fluconazole, pharmacokinetic, candidiasis, sepsis, pediatric, infants, antifungal, candidemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Daniel BenjaminUniversity, hospital or other
- Collaborators
- Pediatric Pharmacology Research Units Network
- Study start
- Nov 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 25 Nov 2008 (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 investigate the pharmacokinetics and safety of a fluconazole loading dose in infants and toddlers.
Detailed description
This is an open label study to investigative the pharmacokinetics and safety of a fluconazole loading dose in infants and toddlers < 2 years of age with suspected sepsis. There will be two treatment groups: single fluconazole loading dose 25 mg/kg; fluconazole loading dose 25mg/kg followed by 12 mg/kg daily for total of 5 days. There will be three age cohorts within each group: pre-term < 30 week EGA infants > 48 hours and < 31 days; > 30 weeks EGA infants > 48 hours and < 31 days; infants ≥ 31 days and < 2 years of age. The study requires administration of fluconazole over 1-5 days depending on treatment group followed by 1 week of safety monitoring. Six to eight 100 µL PK samples will be obtained over the 5 days of drug administration. The risks are reasonable vs. the benefits and have been minimized appropriately. There may be benefit to the subjects (administration of empirical antifungal therapy), and information from the study may benefit a large number of other infants and toddlers with suspected or proven fungal sepsis. There is a data analysis plan.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Loading Dose | Other | Drug: Fluconazole Loading DoseLoading Dose |
| Loading & high dose | Other | Drug: Fluconazole Loading Dose & High DoseLoading dose \& high dose Fluconazole |
Who may qualify
- Ages
- 48 hours to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- suspected sepsis with blood culture within 48 hours
- age ≥ 48 hours and < 2 years of age
- sufficient venous access to permit study drug administration
Key exclusion criteria (5 listed)
- allergic reaction to azole
- history of fluconazole administration in prior 5 days
- liver dysfunction
- renal failure
- concomitant use of cyclosporine, tacrolimus, or azithromycin
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 |
|---|---|---|
| Fluconazole Loading DoseAlso: DiflucanSingle Fluconazole loading dose 25 mg/kg | Drug | Loading Dose |
| Fluconazole Loading Dose & High DoseAlso: DiflucanFluconazole loading dose 25 mg/kg, followed by fluconazole 12 mg/kg q24 hours for total of 5 days | Drug | Loading & high dose |
Primary outcome
Plasma concentration of Fluconazole
Time frame: 6-8 samples over 5 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 5 Nov 2018.
- Background: PubMed 17148010Benjamin DK Jr, Stoll BJ. Infection in late preterm infants. Clin Perinatol. 2006 Dec;33(4):871-82; abstract x. doi: 10.1016/j.clp.2006.09.005.
- Background: PubMed 12165580Stoll BJ, Hansen N, Fanaroff AA, Wright LL, Carlo WA, Ehrenkranz RA, Lemons JA, Donovan EF, Stark AR, Tyson JE, Oh W, Bauer CR, Korones SB, Shankaran S, Laptook AR, Stevenson DK, Papile LA, Poole WK. Late-onset sepsis in very low birth weight neonates: the experience of the NICHD Neonatal Research Network. Pediatrics. 2002 Aug;110(2 Pt 1):285-91. doi: 10.1542/peds.110.2.285.
- Background: PubMed 12949281Benjamin DK Jr, DeLong ER, Steinbach WJ, Cotton CM, Walsh TJ, Clark RH. Empirical therapy for neonatal candidemia in very low birth weight infants. Pediatrics. 2003 Sep;112(3 Pt 1):543-7. doi: 10.1542/peds.112.3.543.
- Background: PubMed 10428919Novelli V, Holzel H. Safety and tolerability of fluconazole in children. Antimicrob Agents Chemother. 1999 Aug;43(8):1955-60. doi: 10.1128/AAC.43.8.1955.
- Background: PubMed 8070441Brammer KW, Coates PE. Pharmacokinetics of fluconazole in pediatric patients. Eur J Clin Microbiol Infect Dis. 1994 Apr;13(4):325-9. doi: 10.1007/BF01974613.
- Background: 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.
- Background: PubMed 7622915Anaissie EJ, Kontoyiannis DP, Huls C, Vartivarian SE, Karl C, Prince RA, Bosso J, Bodey GP. Safety, plasma concentrations, and efficacy of high-dose fluconazole in invasive mold infections. J Infect Dis. 1995 Aug;172(2):599-602. doi: 10.1093/infdis/172.2.599.
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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.
Daniel Benjamin, 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 Loading Dose and Fluconazole Loading Dose & High Dose in people with Candidiasis, run by Daniel Benjamin 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 3 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 5 Nov 2018. 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?
Plasma concentration of Fluconazole (time frame: 6-8 samples over 5 days). 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 NCT00797420, which also lists 7 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 5 Nov 2018.