Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00739934
Other study ID # A1501088
Secondary ID
Status Completed
Phase Phase 2
First received August 20, 2008
Last updated January 26, 2011
Start date December 2008
Est. completion date October 2009

Study information

Verified date January 2011
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

In this study we will measure the concentration of the drug called voriconazole which is used to fight infections caused by fungus in children who usually are cancer patients and have their immune system down. Since we know the dose in adults, and we think we know the matching doses in the young patients ages 2 to 12 years old, we will compare the amount of drug that goes into the system with what we know works in adults. We give the drug by a needle directly into the blood, then few days later we stop that and give the drug by mouth. Meanwhile, we draw a little bit of blood at certain times to measure the drug in it.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date October 2009
Est. primary completion date October 2009
Accepts healthy volunteers No
Gender Both
Age group 2 Years to 11 Years
Eligibility Inclusion Criteria:

- Male or female from 2 to <12 years of age.

- Require treatment for the prevention of systemic fungal infection.

- Expected to develop neutropenia (ANC <500 cells/µL) lasting more than 10 days following chemotherapy.

- Anticipated to live for more than 3 months.

Exclusion Criteria:

- Evidence of any clinically significant liver or renal function or other abnormalities such as cardiac arrhythmia, hypokalemia, hypomagnesemia or hypocalcemia.

- Documented bacterial or viral infection not responding to appropriate treatment.

- Hypersensitivity to or severe intolerance of azole antifungal agents.

- Receiving other azoles or drugs that is are prohibited in the voriconazole label or associated.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
voriconazole (Vfend)
Study Days 1 to 7: IV voriconazole 7 mg/kg q12h. Study Days 8 to 14: Oral voriconazole (POS) 200 mg q12h Notes: If unable to switch to oral medication on Day 8, subjects can continue with IV treatment up to Day 20 before switching to oral dose. Only morning oral dose will be given on Day 14 (or the seventh day of oral dosing if IV regimen is extended). However, if clinically indicated, voriconazole treatment may be continued up to Day 30. (IV = Intravenous; POS = Powder for oral suspension)

Locations

Country Name City State
United States Pfizer Investigational Site Atlanta Georgia
United States Pfizer Investigational Site Atlanta Georgia
United States Pfizer Investigational Site Atlanta Georgia
United States Pfizer Investigational Site Baltimore Maryland
United States Pfizer Investigational Site Cleveland Ohio
United States Pfizer Investigational Site Durham North Carolina
United States Pfizer Investigational Site Houston Texas
United States Pfizer Investigational Site Jacksonville Florida
United States Pfizer Investigational Site Nashville Tennessee
United States Pfizer Investigational Site New Orleans Louisiana
United States Pfizer Investigational Site Orange California
United States Pfizer Investigational Site Portland Oregon
United States Pfizer Investigational Site Tucson Arizona
United States Pfizer Investigational Site Tucson Arizona

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Area Under the Curve Over Dosing Interval at Steady State (AUC12,ss) Following IV Administration AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear/Log trapezoidal method. Day 7 (up to Day 20 or more) at predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose No
Primary Peak Plasma Concentration at Steady State (Cmax,ss) Following IV Administration Day 7 (up to Day 20 or more) at predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose No
Primary Time to Reach Cmax (Tmax) Following IV Administration Day 7 (up to Day 20 or more) at predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose No
Primary AUC12,ss Following Oral Administration AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear/Log trapezoidal method. Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose No
Primary Cmax,ss Following Oral Administration Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose No
Primary Tmax Following Oral Administration Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose No
Secondary AUC12 Following IV Loading Dose AUC12 = Area under the plasma concentration-time profile from time zero (predose) to twelve hours. AUC12 was obtained by the Linear/Log trapezoidal method. Day 1 predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose No
Secondary Cmax Following an IV Loading Dose Day 1 predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose No
Secondary Tmax Following an IV Loading Dose Day 1 predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose No
Secondary Trough Concentrations (Cmin) Day 7 (up to Day 20 or more) for IV; Day 7 (or later) for oral at predose No
Secondary AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear/Log trapezoidal method. Days 1 and 7 (up to Day 20 or more) predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose No
Secondary Cmax,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration Days 1 and 7 (up to Day 20 or more) predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose No
Secondary Tmax of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration Zero Tmax refers to the highest concentration observed for one participant at predose. The profile of the metabolite is relatively flat, which could result in slight variation in sample collection or assay process. Days 1 and 7 (up to Day 20 or more) predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose No
Secondary AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear/Log trapezoidal method. Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose No
Secondary Cmax,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose No
Secondary Tmax of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose No
See also
  Status Clinical Trial Phase
Terminated NCT01982071 - A Study to Evaluate the Efficacy and Safety of Micafungin Against Invasive Candidiasis or Candidemia Phase 4
Completed NCT02391532 - Effect of Probiotic Bacteria on Oral Candida in Frail Elderly N/A
Completed NCT01447407 - Effect of Adjuvant & Route of Administration on Safety & Immunogenicity of NDV-3 Vaccine Phase 1
Not yet recruiting NCT00889356 - Evaluate Efficacy, Tolerability & Safety of Combination of Clindamycin and Ketoconazole for the Treatment of Mixed-Type Vaginosis, Bacterial Vaginosis and Candidiasis Phase 3
Completed NCT00105144 - Study of Micafungin in Patients With Invasive Candidiasis or Candidemia Phase 3
Completed NCT00163111 - A Clinical Study Intended To Compare Treatment With Voriconazole To Treatment With Amphotericin Followed By Fluconazole In Patients With Candidemia, A Serious Fungus Infection Of The Blood. Phase 3
Completed NCT00138502 - Funguria in Hospitalized Patients
Not yet recruiting NCT04502277 - Bioavailability of Flucanazole Early Phase 1
Completed NCT03203551 - Clinical and Laboratorial Evaluation of the Desinfection Solutions in Candida Species From Total Prostheses and Palate of Total Edentulous. N/A
Completed NCT05044156 - Investigation of the Relationship Between Salivary Histatine-5 Level and Vaginal Candidiasis in Women
Completed NCT01322698 - Staging Candidiasis in ICU Patients N/A
Terminated NCT01092832 - A Study Of The Safety, Tolerability And Effective Of Voriconazole For The Treatment Of Serious Candida Infection And Candida Infection Of The Throat In Pediatric Patients Phase 3
Terminated NCT00095316 - Caspofungin Study for Fungal Infections in Adults in Critical Care Settings Phase 3
Completed NCT04122560 - Fluconazole Pharmacokinetics, Including Bioavailability, in Obese Subjects After an Intravenous and Oral Administration Phase 4
Completed NCT02641717 - Validity of Patient-Collected Wet Mounts N/A
Recruiting NCT01253954 - A Multicenter Observational Study of Invasive Candida Infections Among ICU Patients in China N/A
Completed NCT00797420 - Pharmacokinetics (PK) Study of a Fluconazole Loading Dose in Infants and Toddlers Phase 1
Completed NCT00734539 - Fluconazole Prophylaxis for the Prevention of Candidiasis in Infants Less Than 750 Grams Birthweight Phase 3
Completed NCT00001937 - Comparing the Effectiveness of Fluconazole and a New Medicine (FK463) in Preventing Fungal Infections in Bone Marrow Transplant Patients Phase 3
Completed NCT02666716 - Pharmacokinetics of Fluconazole IV as Prophylaxis or Therapy to ICU Patients