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Completed

NCT Number: NCT00143312

Voriconazole for Secondary Prophylaxis of Invasive Fungal Infections in Patients With Allogeneic Stem Cell Transplants

To prevent recurrence of invasive fungal infection in patients with allogeneic stem cell transplants

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Key information

Conditions

Prophylaxis of Invasive Fungal Infections Bacterial Infections and Mycoses Hematologic Diseases Hemic and Lymphatic Diseases Infections Invasive Fungal Infections Leukemia Mycoses Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, Leuven, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with proven or probable IFI in previous 12 months receiving an allogenic stem cell transplant for any haematological disease

Exclusion criteria

  • Pregnant or lactating women
  • Severe disease other tham the underlying condition
  • Active, symptomatic uncontrolled Invasive Fungal Infection
  • Any evidence of active fungal disease as defined by MSG-EORTC criteria
  • Concomitant use of Voriconazole 36 hours before chemotherapy until 48 hours after chemotherapy
  • Other medical conditions, including HIV positive serology that would interfere with the evaluation of therapeutic response or safety of study drug

Treatment and study plan

Voriconazole

Drug

Voriconazole is given to patients at least 48 hours after chemotherapy

Primary outcomes

  1. Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Prophylaxis Until 12-month Follow-up Visit

    Time frame: 12 months

    Number of participants developing a proven or probable IFI from start of voriconazole prophylaxis until 12-month follow up

Secondary outcomes

  1. Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Prophylaxis Until 6-month Follow-up Visit

    Time frame: 6 months

    Number of participants developing a proven or probable IFI from start of voriconazole prophylaxis until 6-month follow up

  2. Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Voriconazole Prophylaxis Until End of Prophylaxis Visit

    Time frame: 150 days

    Number of participants developing a proven or probable IFI from start of voriconazole prophylaxis until the End of Prophylaxis visit

  3. Time to Occurrence of Proven or Probable Invasive Fungal Infection (IFI)

    Time frame: 12 months

    Time to occurrence of proven or probable IFI from the start of voriconazole prophylaxis. Time to occurrence is strictly time to recorded diagnosis of IFI since the exact day on which the IFI began will not be known.

  4. Time to Occurrence of Proven or Probable New (New Pathogen) Invasive Fungal Infection (IFI)

    Time frame: 12 months

    Time to occurrence of proven or probable new (new pathogen) IFI from the start of voriconazole prophylaxis. Time to occurrence is strictly time to recorded diagnosis of IFI.

  5. Time to Occurrence of Proven or Probable Recurrent Invasive Fungal Infection (IFI) (Same Pathogen as Previous Baseline IFI)

    Time frame: 12 months

    Time to occurrence of proven or probable recurrent (same pathogen as baseline) IFI from the start of voriconazole prophylaxis. Time to occurrence is strictly time to recorded diagnosis of IFI. The pathogen identified as the positive culture recorded nearest to, but not after, the proven or probable IFI, was assumed to be responsible for the IFI.

  6. Survival Without Proven or Probable Invasive Fungal Infection (IFI)

    Time frame: 6 months, 12 months

    Number of participants who survive (ie., are alive) without proven or probable IFI at each of the 6 and 12 month follow-up visits

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Collaborators

  • European Society for Blood and Marrow Transplantation

Registry information

Official study title

Prospective, Open-Label, Non-Comparative, Multicenter Study for the Secondary Prophylaxis of Invasive Fungal Infections (IFI) With Voriconazole in Patients With Allogeneic Stem Cell Transplants (SCT).

Acronym: VOSIFI

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Sep 2, 2005
Registry last updated
Oct 6, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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