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Open, Non Comparative Study Of Voriconazole In Slovak Patients With Very High Risk Of Developing An Invasive Fungal Infection

Last updated on April 11, 2018

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Invasive Fungal Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
2+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male or female patient of age 2 years or older.

- High-risk patients with proven, probable or possible invasive fungal infection (IFI)
according to the EORTC/MSG criteria.

- Patients indicated for secondary prophylaxis of invasive aspergillosis.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Patients with known hypersensitivity to voriconazole or to any of the excipients.

- Patients with contraindicated concomitant medications according to the SmPC.

- Children less than 2 years of age.

- Pregnancy and lactation.

NCT01137292
Pfizer
Completed
Open, Non Comparative Study Of Voriconazole In Slovak Patients With Very High Risk Of Developing An Invasive Fungal Infection

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Open, Non Comparative Study Of Voriconazole In Slovak Patients With Very High Risk Of Developing An Invasive Fungal Infection
Voriconazole In High-Risk Patients With Invasive Fungal Infections In Slovakia. An Open, Prospective, Non-Comparative Study
Assessment of safety and efficacy of voriconazole in real-life setting in the treatment of high risk patients with invasive fungal infections. The study is conducted in Slovakia only.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Male or female patients older than 2 years with invasive fungal infections.
Invasive Fungal Infections
Drug: voriconazole (VFEND®)
The use and dosage recommendations for voriconazole (VFEND®) will take place on the basis of the Summary of Product Characteristics (SmPC) and will be adjusted solely according to medical and therapeutic necessity. The formulation and dose will be managed by the treating physician according to the SmPC, disease and clinical situation. According to the SmPC, in the adults the treatment should be started with the loading dose of 6 mg/kg of voriconazole iv. every 12 hours (during the first 24 hrs) followed by the maintenance dose of 4 mg/kg BID. For peroral formulations, the initial dose should be depending on the weight of the patient 400 mg or 200 mg BID during the first 24 hrs, followed by the maintenance dose of 200 mg or 100 mg of voriconazole BID respectively For paediatric population (<12 years of age), there is no initial dose necessary. Depending on the formulation, the daily dosage should be in children 7 mg/kg iv. BID or 200 mg of voriconazole orally BID.
Active Treatment
Patients who are eligible for voriconazole treatment according to their physician decision.
Intervention: Drug: voriconazole (VFEND®)
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
177
November 2009
November 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female patient of age 2 years or older.
  • High-risk patients with proven, probable or possible invasive fungal infection (IFI) according to the EORTC/MSG criteria.
  • Patients indicated for secondary prophylaxis of invasive aspergillosis.

Exclusion Criteria:

  • Patients with known hypersensitivity to voriconazole or to any of the excipients.
  • Patients with contraindicated concomitant medications according to the SmPC.
  • Children less than 2 years of age.
  • Pregnancy and lactation.
Sexes Eligible for Study: All
2 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01137292
A1501082
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2011

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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