Phase 3
N=147
Immediate vs. Deferred Empirical Antifungal Treatment With Voriconazole In Neutropenic Patients
Possible Fungal Infection
Bottom Line
View on ClinicalTrials.gov: NCT00150345 ↗Enrolled (actual)
147
Serious AEs
10.9%
Results posted
Aug 2010
Primary outcome: Primary: Number of Participants With Proven or Probable Invasive Fungal Infections (IFI): Complete Case Analysis — 6; 9 participants — p=0.258
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- voriconazole (Vfend) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Apr 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Proven or Probable Invasive Fungal Infections (IFI): Complete Case Analysis |
6; 9 | 0.258 |
| SECONDARY Number of Participants With Defervescence Day 5 (4 Days After Initiation of Study Treatment) |
32; 28 | 0.596 |
| SECONDARY Number of Participants With Defervescence Day 9 (8 Days After Initiation of Study Treatment) |
42; 34 | 0.864 |
| SECONDARY Time to Continuous Defervescence |
6.0; 5.0 | 0.955 |
| SECONDARY Number of Participants Per Reason for Lack of Defervescence |
3; 3; 7; 6; 1; 0 | — |
| SECONDARY Number of Participants That Died on or Before Day 28 (Mortality) |
4; 1 | — |
| SECONDARY Time to Negative Panfungal Polymerase Chain Reaction (PCR) |
4.0; 5.5 | 0.190 |
| SECONDARY Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association of Positive PCR Assessments With Achievement of Continuous Defervescence (Yes) |
10.6; 8.0 | 0.049 sig |
| SECONDARY Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association of Positive PCR Assessments With Achievement of Continuous Defervescence (No) |
21.7 | — |
| SECONDARY Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Age |
— | — |
| SECONDARY Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Gender |
12.3; 4.2; 10.4; 11.1 | — |
| SECONDARY Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Primary Underlying Neoplastic Disease |
13.9; 9.7; 10.5; 8.8 | — |
| SECONDARY Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Planned Allogeneic Transplants |
10.5; 6.5; 11.9; 8.8 | — |
| SECONDARY Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Concomitant Fluconazole |
13.5; 6.3; 10.9; 8.3 | — |
| SECONDARY Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Neutrophil Count >500 uL |
10.9; 7.9; 12.3; 8.3 | — |
| SECONDARY 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) |
— | — |
| SECONDARY Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Fungal Species Identified |
11.4; 8.0; 11.7; 8.0; 11.4; 8.0 | — |
| SECONDARY Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Fungal Species Identified (Aspergillus Spp=Yes) |
8.3 | — |
| SECONDARY Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Proven or Probable IFI (Complete Cases) Between Day 2 and Day 28 |
0.0; 16.7; 12.1; 7.3 | — |
| SECONDARY Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Defervescence Day 5 (4 Days After Initiation of Study Treatment) |
14.5; 8.3; 3.6; 6.9 | — |
| SECONDARY Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Defervescence (Yes) by Day 9 (8 Days After Initiation of Study Treatment) |
11.0; 8.0 | — |
| SECONDARY Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Defervescence (No) by Day 9 (8 Days After Initiation of Study Treatment) |
20.0 | — |
| SECONDARY Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Time to Defervescence |
— | — |
| SECONDARY Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Reasons for Lack of Continuous Defervescence (No) |
11.4; 8.0; 11.4; 8.0; 11.4; 8.0 | — |
| SECONDARY Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Reasons for Lack of Continuous Defervescence: Unknown Infection (Yes) |
21.7 | — |
| SECONDARY Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Mortality by Day 28 (Alive) |
11.4; 8.0 | — |
| SECONDARY Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Mortality by Day 28 (Died) |
— | — |
| SECONDARY Number of Participants Assessed as Needing Further Antineoplastic Therapy as Planned |
42; 32 | — |
| SECONDARY Number of Participants With Reasons Why Antineoplastic Therapy Not Continued as Planned |
— | — |
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.
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- Documented bacterial infection during screening or at randomization
- Fungemia or other documented invasive fungal infection during screening or at randomization.
Data sourced from ClinicalTrials.gov (NCT00150345). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.