Possible Fungal InfectionPhase 3IDEANCT00150345
Immediate vs. Deferred Empirical Antifungal Treatment With Voriconazole In Neutropenic Patients
A Phase 3 study testing voriconazole (Vfend) in people with Possible Fungal Infection, run by Pfizer at 28 sites in Germany.
Trial summary
A well-known side-effect of cytostatics (drugs against malignancies) is a decrease in the number of white blood cells, especially of the so-called neutrophil granulocytes, which are very important for the defense against infections. Hence their decrease (called "neutropenia") leads to a predisposition to infections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Possible Fungal Infection
- What is being tested?
- voriconazole (Vfend)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 28 sitesGermany
- Study dates
- Jan 2005to Apr 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute leukemia, aggressive lymphoma, bone marrow or stem cell transplantation;
- Neutropenia (<500 neutrophils/µL) of at least 10 days;
- Newly diagnosed fever;
- Positive panfungal polymerase chain reaction assay
Who cannot join
- Documented bacterial infection during screening or at randomization
- Fungemia or other documented invasive fungal infection during screening or at randomization.
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
Germany28 sites
Pfizer Investigational Site
Augsburg, 86156
Pfizer Investigational Site
Berlin, 10117
Pfizer Investigational Site
Berlin, 12200
Pfizer Investigational Site
Berlin, 13353
Pfizer Investigational Site
Bielefeld, 33611
Pfizer Investigational Site
Bremen, 28177
Pfizer Investigational Site
Chemnitz, 09113
Pfizer Investigational Site
Cologne, 50937
Pfizer Investigational Site
Dresden, 01307
Pfizer Investigational Site
Erlangen, 91054
Pfizer Investigational Site
Essen, 45239
Pfizer Investigational Site
Frankfurt (Oder), 15236
Pfizer Investigational Site
Freiburg im Breisgau, 79106
Pfizer Investigational Site
Göttingen, 37075
Pfizer Investigational Site
Hanover, 30623
Pfizer Investigational Site
Homburg/Saar, 66421
Pfizer Investigational Site
Kiel, 24116
Pfizer Investigational Site
Leipzig, 04103
Pfizer Investigational Site
Lübeck, 23538
Pfizer Investigational Site
Ludwigshafen, 67063
Pfizer Investigational Site
Mainz, 55101
Pfizer Investigational Site
München, 81675
Pfizer Investigational Site
München, 81737
Pfizer Investigational Site
Potsdam, 14467
Pfizer Investigational Site
Stuttgart, 70376
Pfizer Investigational Site
Trier, 54290
Pfizer Investigational Site
Wiesbaden, 65191
Pfizer Investigational Site
Würzburg, 97070
About this study
Official title: Immediate vs. Deferred Empirical Antifungal Treatment With Voriconazole In High-Risk Neutropenic Patients With Fever And A Positive Panfungal Polymerase Chain Reaction Assay (IDEA Study)
A well-known side-effect of cytostatics (drugs against malignancies) is a decrease in the number of white blood cells, especially of the so-called neutrophil granulocytes, which are very important for the defense against infections. Hence their decrease (called "neutropenia") leads to a predisposition to infections.
Since infections during neutropenia can be very dangerous, the patients are treated with antibiotics from the very first signs of such an infection (usually fever). If the antibiotics (drugs against bacteria) do not lead to a normalization of the body temperature within four days, a drug against fungi is added.
Read more
In the IDEA study, one half of the patients receive the antifungal drug voriconazole (as usual) only in case the antibiotics alone do not lead to a normalization of the body temperature (current standard of care). The other half of the patients receive voriconazole immediately after onset of fever (concomitantly with the antibiotics).
The research question is, whether in the "early-treatment" group fewer manifest fungal infections will be observed than in the "late-treatment" group.
- Conditions
- Possible Fungal Infection
- Being tested
- voriconazole (Vfend)
- Keywords
- Neutropenia, Fever of unknown origin, Empirical treatment, Voriconazole
- Medical subject headings
- Neutropenia, Fever of Unknown Origin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
voriconazole (Vfend)Drug
voriconazole, early treatment
voriconazole (Vfend)Drug
voriconazole, deferred treatment
| Study group | Role | What they receive |
|---|---|---|
| Early treatment | Experimental | Voriconazole starts within 18 hours of onset of fever intravenously with a loading dose of 6 mg/kg q12h for the first two doses followed by 4 mg/kg q12h (maintenance dose). Switched to oral treatment (200 mg BID) is possible after at least four days. Treatment will be ended if the patient is afebrile (< 38.0 °C) for 7 days with neutrophil counts < 500/µL, or if the patient is afebrile (< 38.0 °C) for 2 days with neutrophil counts > 500/µL. Receives: Drug: voriconazole (Vfend) |
| Deferred treatment | Other | Treatment with voriconazole (for dosage see "early treatment arm") is initiated only if a patient is persistently febrile on day 5 after the onset of fever despite antibiotic treatment. Receives: Drug: voriconazole (Vfend) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Proven or Probable Invasive Fungal Infections (IFI): Complete Case Analysis
Number of participants with proven (deep tissue infection, fungemia, or endemic fungal infections) or probable IFI (at least 1 host criterion [fever, body temperature <36 or >38 degrees Celsius, graft-versus-host disease, use of corticosteroids]; and 1 microbiological criterion [fungal or yeasts]; or clinical criteria [abnormal site consistent with infection]) as defined by European Organization for Research and Treatment of Cancer Mycosis Study Group (EORTC/MSG) criteria. Complete case analysis: must be evaluable until Day 28 or had developed a proven or probable IFI by the final visit.
Measured: Day 2 through Day 28
Secondary outcomes (28)
Number of Participants With Defervescence Day 5 (4 Days After Initiation of Study Treatment)
Number of participants who achieved defervescence (were afebrile). Defervescence stated if all of a participants's body temperatures within 24 hours of evaluation time were <38.0 degrees C. Defervescence was not stated and participant was discontinued from the study if participant received antipyretics (non-steroidal anti-inflammatory drugs or paracetamol).
Measured: Day 5 (96 hours through 120 hours after start of study treatment)
Number of Participants With Defervescence Day 9 (8 Days After Initiation of Study Treatment)
Number of participants who achieved defervescence (were afebrile). Defervescence stated if all of a participant's body temperatures within 24 hours of evaluation time were <38.0 degrees C. Defervescence was not stated and participant was discontinued from the study if participant received antipyretics (non-steroidal anti-inflammatory drugs or paracetamol).
Measured: Day 9 (192 hours through 216 hours after start of study treatment)
Time to Continuous Defervescence
Time (in days) from start of study medication to continuous defervescence. Continuous defervescence stated if participant maintains a body temperature of <38.0 degrees C for at least 96 hours.
Measured: Day 2 through Day 28
Number of Participants Per Reason for Lack of Defervescence
Measured: Day 2 through Day 28
Number of Participants That Died on or Before Day 28 (Mortality)
Number of participants that died on or before Day 28 after start of study treatment. A participant must be evaluable until Day 28 (final visit) or have died before the final visit.
Measured: Day 2 through Day 28
Time to Negative Panfungal Polymerase Chain Reaction (PCR)
Time (in days) from start of study medication to negative panfungal PCR; assessed for participants whose most recent panfungal PCR result prior to start of study medication was positive. Defined as negative if at least 2 successive and all following panfungal PCR assessments from start of study medication until 24 hours after end of treatment are negative. Measured as first quartile of time (point in time measurement; no median or measure of dispersion calculated); median time was not estimable for deferred voriconazole treatment group.
Measured: Day 2 through Day 28
Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association of Positive PCR Assessments With Achievement of Continuous Defervescence (Yes)
Percent of positive panfungal PCR assessments during treatment phase of study in association with achievement of continuous defervescence (response=Yes). Continuous defervescence stated if participant maintains a body temperature of <38.0 degrees C for at least 96 hours. Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.
Measured: Day 2 through Day 28
Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association of Positive PCR Assessments With Achievement of Continuous Defervescence (No)
Percent of positive panfungal PCR assessments during treatment phase of study in association with achievement of continuous defervescence (response=No). Continuous defervescence stated if participant maintains a body temperature of <38.0 degrees C for at least 96 hours. Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.
Measured: Day 2 through Day 28
Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Age
Percent of positive panfungal PCR assessments during treatment phase of study in association with age for participants who completed the study and have a non-missing value for percent of positive panfungal PCR.
Measured: Day 2 through Day 28
Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Gender
Percent of positive panfungal PCR assessments during treatment phase of study in association with gender (Female or Male). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.
Measured: Day 2 through Day 28
Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Primary Underlying Neoplastic Disease
Percent of positive panfungal PCR assessments during treatment phase of study in association with primary underlying neoplastic disease. Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.
Measured: Day 2 through Day 28
Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Planned Allogeneic Transplants
Percent of positive panfungal PCR assessments during treatment phase of study in association with allogeneic bone marrow transplant or allogeneic peripheral stem cell transplant (Yes or No). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.
Measured: Day 2 through Day 28
Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Concomitant Fluconazole
Percent positive panfungal PCR assessments during treatment phase of study in association with use of concomitant (prophylaxis) fluconazole (Yes or No). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.
Measured: Day 2 through Day 28
Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Neutrophil Count >500 uL
Percent of positive panfungal PCR assessments during treatment phase of study in association with neutrophil count >500 uL (Yes or No). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.
Measured: Day 2 through Day 28
Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With C-reactive Protein Level >1.25 Times the Upper Limit of Normal (x ULN)
Percent of positive panfungal PCR assessments during treatment phase of study in association with c-reactive protein level (measured in milligrams per liter [mg/L]) >1.25 x ULN (Yes or No). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.
Measured: Day 2 through Day 28
Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Fungal Species Identified
Percent of positive panfungal PCR assessments during treatment phase of study in association with fungal species (singular [one species]=sp; plural [many species]=spp) identified (Yes or No). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.
Measured: Day 2 through Day 28
Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Fungal Species Identified (Aspergillus Spp=Yes)
Percent of positive panfungal PCR assessments during treatment phase of study in association with fungal species (singular [one species]=sp; plural [many species]=spp) identified (Yes). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.
Measured: Day 2 through Day 28
Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Proven or Probable IFI (Complete Cases) Between Day 2 and Day 28
Percent of positive panfungal PCR assessments during treatment phase of study in association with proven or probable IFI (complete cases) between Day 2 and Day 28 (Yes or No). Complete case analysis: participant must be evaluable until Day 28 (final visit) or have developed a proven or probable IFI by the final visit. Participant considered evaluable until Day 28 if participant completed the study and completed an assessment of IFI at Day 28 or final visit. Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.
Measured: Day 2 through Day 28
Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Defervescence Day 5 (4 Days After Initiation of Study Treatment)
Percent of positive panfungal PCR assessments during treatment phase of study in association with defervescence (were afebrile) Day 5 (Yes or No). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.
Measured: Day 5 (96 hours through 120 hours after start of study treatment)
Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Defervescence (Yes) by Day 9 (8 Days After Initiation of Study Treatment)
Percent of positive panfungal PCR assessments during treatment phase of study in association with defervescence (were afebrile) Day 9 (Yes). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.
Measured: Day 2 through Day 9 (192 hours through 216 hours after start of study treatment)
Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Defervescence (No) by Day 9 (8 Days After Initiation of Study Treatment)
Percent of positive panfungal PCR assessments during treatment phase of study in association with defervescence (were afebrile) Day 9 (No). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.
Measured: Day 2 through Day 9 (192 hours through 216 hours after start of study treatment)
Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Time to Defervescence
Percent of positive panfungal PCR assessments during treatment phase of study in association with time to defervescence. Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.
Measured: Day 2 through Day 28
Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Reasons for Lack of Continuous Defervescence (No)
Percent of positive panfungal PCR assessments during treatment phase of study in association with lack of continuous defervescence (No). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.
Measured: Day 2 through Day 28
Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Reasons for Lack of Continuous Defervescence: Unknown Infection (Yes)
Percent of positive panfungal PCR assessments during treatment phase of study in association with lack of continuous defervescence (Yes). Percent calculated as number of positive PCR assessments divided by number of all PCR assessments in treatment phase multiplied by 100.
Measured: Day 2 through Day 28
Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Mortality by Day 28 (Alive)
Percent of positive panfungal PCR assessments during treatment phase of study in association with mortality on or before Day 28 after start of study treatment (Alive). A participant must be evaluable until Day 28 (final visit).
Measured: Day 2 through Day 28
Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Mortality by Day 28 (Died)
Percent of positive panfungal PCR assessments during treatment phase of study in association with mortality on or before Day 28 after start of study treatment (Died). A participant must have died before Day 28 (final visit).
Measured: Day 2 through Day 28
Number of Participants Assessed as Needing Further Antineoplastic Therapy as Planned
Measured: Day 28
Number of Participants With Reasons Why Antineoplastic Therapy Not Continued as Planned
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startJan 2005
- Primary completionApr 2009
- Study completionApr 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 Possible Fungal InfectionStudies 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.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Infectious Diseases Working Party (AGIHO) of the German Society of Hematology and Oncology (DGHO)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00150345
- Sponsor's protocol ID
- A1501029
- Acronym
- IDEA
- Status last verified
- Jan 2012
- First submitted
- 6 Sep 2005
- Last updated
- 19 Jan 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate vs. Deferred Empirical Antifungal Treatment With Voriconazole In High-Risk Neutropenic Patients With Fever And A Positive Panfungal Polymerase Chain Reaction Assay (IDEA Study)
- ClinicalTrials.gov ID
- NCT00150345
- Acronym / sponsor ID
- IDEA / A1501029
- Conditions
- Possible Fungal Infection
- Keywords
- Neutropenia, Fever of unknown origin, Empirical treatment, Voriconazole
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Collaborators
- Infectious Diseases Working Party (AGIHO) of the German Society of Hematology and Oncology (DGHO)
- Study start
- Jan 2005
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 8 Sep 2005 (estimated)
- Results
- Posted 18 Aug 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A well-known side-effect of cytostatics (drugs against malignancies) is a decrease in the number of white blood cells, especially of the so-called neutrophil granulocytes, which are very important for the defense against infections. Hence their decrease (called "neutropenia") leads to a predisposition to infections.
Since infections during neutropenia can be very dangerous, the patients are treated with antibiotics from the very first signs of such an infection (usually fever). If the antibiotics (drugs against bacteria) do not lead to a normalization of the body temperature within four days, a drug against fungi is added.
In the IDEA study, one half of the patients receive the antifungal drug voriconazole (as usual) only in case the antibiotics alone do not lead to a normalization of the body temperature (current standard of care). The other half of the patients receive voriconazole immediately after onset of fever (concomitantly with the antibiotics).
The research question is, whether in the "early-treatment" group fewer manifest fungal infections will be observed than in the "late-treatment" group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early treatment | Experimental | Drug: voriconazole (Vfend)Voriconazole starts within 18 hours of onset of fever intravenously with a loading dose of 6 mg/kg q12h for the first two doses followed by 4 mg/kg q12h (maintenance dose). Switched to oral treatment (200 mg BID) is possible after at least four days. Treatment will be ended if the patient is afebrile (< 38.0 °C) for 7 days with neutrophil counts < 500/µL, or if the patient is afebrile (< 38.0 °C) for 2 days with neutrophil counts > 500/µL. |
| Deferred treatment | Other | Drug: voriconazole (Vfend)Treatment with voriconazole (for dosage see "early treatment arm") is initiated only if a patient is persistently febrile on day 5 after the onset of fever despite antibiotic treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Acute leukemia, aggressive lymphoma, bone marrow or stem cell transplantation;
- Neutropenia (<500 neutrophils/µL) of at least 10 days;
- Newly diagnosed fever;
- Positive panfungal polymerase chain reaction assay
Key exclusion criteria (2 listed)
- Documented bacterial infection during screening or at randomization
- Fungemia or other documented invasive fungal infection during screening or at randomization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| voriconazole (Vfend)voriconazole, early treatment | Drug | Early treatment |
| voriconazole (Vfend)voriconazole, deferred treatment | Drug | Deferred treatment |
Primary outcome
Number of Participants With Proven or Probable Invasive Fungal Infections (IFI): Complete Case Analysis
Time frame: Day 2 through Day 28
Number of participants with proven (deep tissue infection, fungemia, or endemic fungal infections) or probable IFI (at least 1 host criterion [fever, body temperature <36 or >38 degrees Celsius, graft-versus-host disease, use of corticosteroids]; and 1 microbiological criterion [fungal or yeasts]; or clinical criteria [abnormal site consistent with infection]) as defined by European Organization for Research and Treatment of Cancer Mycosis Study Group (EORTC/MSG) criteria. Complete case analysis: must be evaluable until Day 28 or had developed a proven or probable IFI by the final visit.
28 secondary outcomes
Number of Participants With Defervescence Day 5 (4 Days After Initiation of Study Treatment)
Time frame: Day 5 (96 hours through 120 hours after start of study treatment)
Number of Participants With Defervescence Day 9 (8 Days After Initiation of Study Treatment)
Time frame: Day 9 (192 hours through 216 hours after start of study treatment)
Time to Continuous Defervescence
Time frame: Day 2 through Day 28
Number of Participants Per Reason for Lack of Defervescence
Time frame: Day 2 through Day 28
Number of Participants That Died on or Before Day 28 (Mortality)
Time frame: Day 2 through Day 28
Time to Negative Panfungal Polymerase Chain Reaction (PCR)
Time frame: Day 2 through Day 28
Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association of Positive PCR Assessments With Achievement of Continuous Defervescence (Yes)
Time frame: Day 2 through Day 28
Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association of Positive PCR Assessments With Achievement of Continuous Defervescence (No)
Time frame: Day 2 through Day 28
Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Age
Time frame: Day 2 through Day 28
Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Gender
Time frame: Day 2 through Day 28
Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Primary Underlying Neoplastic Disease
Time frame: Day 2 through Day 28
Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Planned Allogeneic Transplants
Time frame: Day 2 through Day 28
Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Concomitant Fluconazole
Time frame: Day 2 through Day 28
Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Neutrophil Count >500 uL
Time frame: Day 2 through Day 28
Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With C-reactive Protein Level >1.25 Times the Upper Limit of Normal (x ULN)
Time frame: Day 2 through Day 28
Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Fungal Species Identified
Time frame: Day 2 through Day 28
Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Fungal Species Identified (Aspergillus Spp=Yes)
Time frame: Day 2 through Day 28
Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Proven or Probable IFI (Complete Cases) Between Day 2 and Day 28
Time frame: Day 2 through Day 28
Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Defervescence Day 5 (4 Days After Initiation of Study Treatment)
Time frame: Day 5 (96 hours through 120 hours after start of study treatment)
Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Defervescence (Yes) by Day 9 (8 Days After Initiation of Study Treatment)
Time frame: Day 2 through Day 9 (192 hours through 216 hours after start of study treatment)
Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Defervescence (No) by Day 9 (8 Days After Initiation of Study Treatment)
Time frame: Day 2 through Day 9 (192 hours through 216 hours after start of study treatment)
Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Time to Defervescence
Time frame: Day 2 through Day 28
Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Reasons for Lack of Continuous Defervescence (No)
Time frame: Day 2 through Day 28
Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Reasons for Lack of Continuous Defervescence: Unknown Infection (Yes)
Time frame: Day 2 through Day 28
Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Mortality by Day 28 (Alive)
Time frame: Day 2 through Day 28
Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Mortality by Day 28 (Died)
Time frame: Day 2 through Day 28
Number of Participants Assessed as Needing Further Antineoplastic Therapy as Planned
Time frame: Day 28
Number of Participants With Reasons Why Antineoplastic Therapy Not Continued as Planned
Time frame: Day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing voriconazole (Vfend) in people with Possible Fungal Infection, run by Pfizer at 28 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Aug 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Proven or Probable Invasive Fungal Infections (IFI): Complete Case Analysis (time frame: Day 2 through Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2012.