Clinical Trials Logo
  1. Home
  2. Candidiasis
  3. NCT00001810

An Open Label, Non-Comparative, Multicenter, Phase III Trial of the Efficacy, Safety and Toleration of Voriconazole in the Primary or Secondary Treatment of Invasive Fungal Infections

Candidiasis Clinical Trial

Official title:
An Open Label, Non-Comparative, Multicenter, Phase III Trial of the Efficacy, Safety and Toleration of Voriconazole in the Primary or Secondary Treatment of Invasive Fungal Infections

Clinical Trial Summary

The objective of this study is to evaluate the efficacy, safety and toleration of voriconazole in the primary treatment of systemic or invasive fungal infections due to fungal pathogens for which there is no licensed therapy; and in the secondary treatment of systemic or invasive fungal infections in patients failing or intolerant to treatment with approved systemic antifungal agents. This trial is a Phase II multicenter, open label study investigating the utilization of voriconazole for the treatment of systemic or invasive fungal infections. Enrollment is targeted for 150 patients to be recruited from multiple centers. The patient population will consist of patients with proven, deeply invasive fungal infection for which there is no licensed therapy or if the patient is failing or intolerant to treatment with approved systemic antifungal agents. Voriconazole will be administered initially by a loading dose of 6 mg/kg q12 hours for the first two doses followed by 4 mg/kg q12 hours. Efficacy will be evaluated by clinical, radiological and microbiological response.

Clinical Trial Description

The objective of this study is to evaluate the efficacy, safety and toleration of voriconazole in the primary treatment of systemic or invasive fungal infections due to fungal pathogens for which there is no licensed therapy; and in the secondary treatment of systemic or invasive fungal infections in patients failing or intolerant to treatment with approved systemic antifungal agents. This trial is a Phase III multicenter, open label study investigating the utilization of voriconazole for the treatment of systemic or invasive fungal infections. Enrollment is targeted for 150 patients to be recruited from multiple centers. The patient population will consist of patients with proven, deeply invasive fungal infection for which there is no licensed therapy or if the patient is failing or intolerant to treatment with approved systemic antifungal agents. Voriconazole will be administered initially by a loading dose of 6 mg/kg q12 hours for the first two doses followed by 4 mg/kg q12 hours. Efficacy will be evaluated by clinical, radiological and microbiological response. ;

Study Design

Endpoint Classification: Efficacy Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00001810
Study type Interventional
Source National Institutes of Health Clinical Center (CC)
Contact
Status Completed
Phase Phase 3
Start date April 1999
Completion date October 2000
View Details
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