NCT00797420

Brief Summary

The purpose of this study is to investigate the pharmacokinetics and safety of a fluconazole loading dose in infants and toddlers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2008

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

November 23, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 25, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

November 5, 2018

Status Verified

November 1, 2018

Enrollment Period

1.2 years

First QC Date

November 23, 2008

Last Update Submit

November 2, 2018

Conditions

Candidiasis

Keywords

fluconazolepharmacokineticcandidiasissepsispediatricinfantsantifungalcandidemiafungemialoading dose

Outcome Measures

Primary Outcomes (1)

  • Plasma concentration of Fluconazole

    6-8 samples over 5 days

Study Arms (2)

Loading Dose

OTHER

Loading Dose

Drug: Fluconazole Loading Dose

Loading & high dose

OTHER

Loading dose \& high dose Fluconazole

Drug: Fluconazole Loading Dose & High Dose

Interventions

Fluconazole Loading DoseDRUG

Single Fluconazole loading dose 25 mg/kg

Also known as: Diflucan
Loading Dose
Fluconazole Loading Dose & High DoseDRUG

Fluconazole loading dose 25 mg/kg, followed by fluconazole 12 mg/kg q24 hours for total of 5 days

Also known as: Diflucan
Loading & high dose

Eligibility Criteria

Age48 Hours - 2 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • suspected sepsis with blood culture within 48 hours
  • age ≥ 48 hours and \< 2 years of age
  • sufficient venous access to permit study drug administration

You may not qualify if:

  • allergic reaction to azole
  • history of fluconazole administration in prior 5 days
  • liver dysfunction
  • renal failure
  • concomitant use of cyclosporine, tacrolimus, or azithromycin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke Univeristy Medical Center

Durham, North Carolina, 27715, United States

Location

Related Publications (7)

  • 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.

    PMID: 17148010BACKGROUND

  • Stoll 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.

    PMID: 12165580BACKGROUND

  • Benjamin 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.

    PMID: 12949281BACKGROUND

  • Novelli 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.

    PMID: 10428919BACKGROUND

  • Brammer 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.

    PMID: 8070441BACKGROUND

  • Wade 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.

    PMID: 18809946BACKGROUND

  • Anaissie 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.

    PMID: 7622915BACKGROUND

MeSH Terms

Conditions

CandidiasisSepsisCandidemiaFungemia

Interventions

Fluconazole

Condition Hierarchy (Ancestors)

MycosesBacterial Infections and MycosesInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsCandidiasis, InvasiveInvasive Fungal Infections

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Daniel Benjamin, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Pediatrics

Study Record Dates

First Submitted

November 23, 2008

First Posted

November 25, 2008

Study Start

November 1, 2008

Primary Completion

January 1, 2010

Study Completion

September 1, 2011

Last Updated

November 5, 2018

Record last verified: 2018-11

Locations

US(1)