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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 2 years and older
• All sexes
• No healthy volunteers
• Child, Adult, Older adult

Study population: Male or female patients older than 2 years with invasive fungal infections.

About this study

Official title: Voriconazole In High-Risk Patients With Invasive Fungal Infections In Slovakia. An Open, Prospective, Non-Comparative Study

Conditions

Invasive Fungal Infections

Being tested

voriconazole (VFEND®)

Keywords

observational study, voriconazole, high-risk patients

Medical subject headings

Invasive Fungal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• voriconazole (VFEND®)Drug

  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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Number of Participants With Clinical and/or Mycological Efficacy by Response at the End of Treatment (EOT) Visit

   Clinical, mycological responses: clinical cure, clinical improvement, no clinical cure, mycological cure, no mycological cure, and no mycological culture performed. Participants could have had more than one response. Responses were based on the investigator's judgement according to the Infectious Disease Society of America, European Conference on Infections in Leukemia, and European Committee on Antimicrobial Susceptibility Testing guidelines.

   Measured: up to 2 weeks (EOT visit)

2. Number of Participants With Clinical and/or Mycological Efficacy by Response at the Test-of-Cure Visit

   Clinical, mycological responses: clinical cure, clinical improvement, no clinical cure, mycological cure, no mycological cure, no mycological culture performed, death, and lost from follow-up. Participants could have had more than one response. Responses were based on the investigator's judgement according to the Infectious Disease Society of America, European Conference on Infections in Leukemia, and European Committee on Antimicrobial Susceptibility Testing guidelines.

   Measured: more than 2 weeks (Test-of-Cure visit)

3. Number of Participants With Investigator's Satisfaction With the Efficacy of Voriconazole Assessment at the EOT Visit

   Investigator's Satisfaction Responses: very good, good, moderate, poor. Responses were based on the investigator's judgement.

   Measured: up to 2 weeks (EOT visit)

4. Number of Participants With Investigator's Satisfaction With the Tolerability of Voriconazole Assessment at the EOT Visit

   Investigator's Satisfaction Responses: very good, good, moderate, poor. Responses were based on the investigator's judgement.

   Measured: up to 2 weeks (EOT visit)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted4 Jun 2010 (estimated)
2. Study startApr 2007
3. Primary completionNov 2009
4. Study completionNov 2009

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
• Other trials for Invasive Fungal InfectionsStudies of the same condition, open and under way.
• More trials run by PfizerThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.