Pharmacokinetics (PK) Study of a Fluconazole Loading Dose in Infants and Toddlers

November 2, 2018 updated by: Daniel Benjamin

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27715
        • Duke Univeristy Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 days to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Loading Dose
Drug: Fluconazole Loading Dose
Single Fluconazole loading dose 25 mg/kg
Other Names:
  • Diflucan
Other: Loading & high dose
Loading dose & high dose Fluconazole
Drug: Fluconazole Loading Dose & High Dose
Fluconazole loading dose 25 mg/kg, followed by fluconazole 12 mg/kg q24 hours for total of 5 days
Other Names:
  • Diflucan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma concentration of Fluconazole
Time Frame: 6-8 samples over 5 days
6-8 samples over 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daniel Benjamin

Collaborators

Pediatric Pharmacology Research Units Network

Investigators

  • Principal Investigator: Daniel Benjamin, MD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

November 23, 2008

First Submitted That Met QC Criteria

November 24, 2008

First Posted (Estimate)

November 25, 2008

Study Record Updates

Last Update Posted (Actual)

November 5, 2018

Last Update Submitted That Met QC Criteria

November 2, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00011454
  • NIH-5U10-HD-045962-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Candidiasis

Clinical Trials on Fluconazole Loading Dose

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uzbekistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe