Trial · NCT00150345
Immediate vs. Deferred Empirical Antifungal Treatment With Voriconazole In Neutropenic Patients
NCT00150345, Phase 3, Completed, Pfizer; results first posted 2010-08-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Immediate vs. Deferred Empirical Antifungal Treatment With Voriconazole In Neutropenic Patients. Trials, record NCT00150345. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00150345
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Immediate vs. Deferred Empirical Antifungal Treatment With Voriconazole In Neutropenic Patients
- NCT number
- NCT00150345
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 147 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Possible Fungal Infection
- Interventions
- voriconazole (Vfend), voriconazole (Vfend)
- First posted
- 2005-09-08
- Last updated
- 2012-01-19
- Results first posted
- 2010-08-18
- Limitations and caveats
One participant in the Immediate Voriconazole treatment group was incorrectly included in the original Primary efficacy analysis and has now been excluded; IFI was identified on the day study treatment started (not prior to study treatment).
Source ClinicalTrials.gov
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Proven or Probable Invasive Fungal Infections (IFI): Complete Case Analysis | 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. |
| Secondary | Number of Participants With Defervescence Day 5 (4 Days After Initiation of Study Treatment) | Day 5 (96 hours through 120 hours after start 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). |
| Secondary | Number of Participants With Defervescence Day 9 (8 Days After Initiation of Study Treatment) | Day 9 (192 hours through 216 hours after start 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). |
| Secondary | Time to Continuous Defervescence | Day 2 through Day 28 | 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. |
| Secondary | Number of Participants Per Reason for Lack of Defervescence | Day 2 through Day 28 | |
| Secondary | Number of Participants That Died on or Before Day 28 (Mortality) | Day 2 through Day 28 | 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. |
| Secondary | Time to Negative Panfungal Polymerase Chain Reaction (PCR) | Day 2 through Day 28 | 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. |
| Secondary | Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association of Positive PCR Assessments With Achievement of Continuous Defervescence (Yes) | Day 2 through Day 28 | 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. |
| Secondary | Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association of Positive PCR Assessments With Achievement of Continuous Defervescence (No) | Day 2 through Day 28 | 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. |
| Secondary | Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Age | Day 2 through Day 28 | 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. |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 registered outcomesOutcomes29
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Proven or Probable Invasive Fungal Infections (IFI): Complete Case Analysis | Day 2 through Day 28 | Modified Intent-to-Treat population (MITT): participants in ITT population (at least 1 dose of study treatment) with valid post-baseline proven or probable IFI, did not have fungemia or other IFI at screening or randomization, no antipyretic analgesics on Day 5 (or Day 9 of open-label voriconazole). N=number of complete case evaluable participants. | participants | NUMBER |
| SECONDARY | Number of Participants With Defervescence Day 5 (4 Days After Initiation of Study Treatment) | Day 5 (96 hours through 120 hours after start of study treatment) | MITT | participants | NUMBER |
| SECONDARY | Number of Participants With Defervescence Day 9 (8 Days After Initiation of Study Treatment) | Day 9 (192 hours through 216 hours after start of study treatment) | MITT | particpants | NUMBER |
| SECONDARY | Time to Continuous Defervescence | Day 2 through Day 28 | MITT | days | MEDIAN |
| SECONDARY | Number of Participants Per Reason for Lack of Defervescence | Day 2 through Day 28 | MITT | participants | NUMBER |
| SECONDARY | Number of Participants That Died on or Before Day 28 (Mortality) | Day 2 through Day 28 | MITT; N=number of participants evaluable until Day 28 (final visit) or died before the final visit. | participants | NUMBER |
| SECONDARY | Time to Negative Panfungal Polymerase Chain Reaction (PCR) | Day 2 through Day 28 | MITT; N=number of participants whose most recent panfungal PCR result prior to start of study medication was positive. | days | NUMBER |
| SECONDARY | Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association of Positive PCR Assessments With Achievement of Continuous Defervescence (Yes) | Day 2 through Day 28 | MITT; N=number of participants who completed the study and had a non-missing value for percent of positive panfungal PCR. | percent of positive PCR assessments | MEAN |
| SECONDARY | Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association of Positive PCR Assessments With Achievement of Continuous Defervescence (No) | Day 2 through Day 28 | MITT; N=number of participants who completed the study and had a non-missing value for percent of positive panfungal PCR. | percent of positive PCR assessments | MEAN |
| SECONDARY | Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Age | Day 2 through Day 28 | MITT. Correlation of positive panfungal PCR assessments with age was not summarized as planned. | percent of positive PCR assessments | MEAN |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 outcomesResults by group98
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Proven or Probable Invasive Fungal Infections (IFI): Complete Case Analysis | Immediate Voriconazole | 6 | participants | ||
| Number of Participants With Proven or Probable Invasive Fungal Infections (IFI): Complete Case Analysis | Deferred Voriconazole Treatment | 9 | participants | ||
| Number of Participants With Defervescence Day 5 (4 Days After Initiation of Study Treatment) | Immediate Voriconazole | 32 | participants | ||
| Number of Participants With Defervescence Day 5 (4 Days After Initiation of Study Treatment) | Deferred Voriconazole Treatment | 28 | participants | ||
| Number of Participants With Defervescence Day 9 (8 Days After Initiation of Study Treatment) | Immediate Voriconazole | 42 | particpants | ||
| Number of Participants With Defervescence Day 9 (8 Days After Initiation of Study Treatment) | Deferred Voriconazole Treatment | 34 | particpants | ||
| Time to Continuous Defervescence | Immediate Voriconazole | 6.0 | 95% Confidence Interval 4.0 to 8.0 | days | |
| Time to Continuous Defervescence | Deferred Voriconazole Treatment | 5.0 | 95% Confidence Interval 4.0 to 7.0 | days | |
| Number of Participants Per Reason for Lack of Defervescence | Immediate Voriconazole | Fungal infection | 3 | participants | |
| Number of Participants Per Reason for Lack of Defervescence | Deferred Voriconazole Treatment | Fungal infection | 3 | participants |
1 to 10 of 98Source ClinicalTrials.gov
See all 98 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Immediate Voriconazole | 81 | |
| Overall Study | STARTED | Deferred Voriconazole Treatment | 66 | |
| Overall Study | COMPLETED | Immediate Voriconazole | 47 | |
| Overall Study | COMPLETED | Deferred Voriconazole Treatment | 34 | |
| Overall Study | NOT COMPLETED | Immediate Voriconazole | 34 | |
| Overall Study | NOT COMPLETED | Deferred Voriconazole Treatment | 32 |
Source ClinicalTrials.gov
Adverse events82
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Visual impairment | Eye disorders | Immediate Voriconazole | 5 | 81 | |
| other | Visual impairment | Eye disorders | Deferred Voriconazole Treatment | 2 | 66 | |
| other | Abdominal pain | Gastrointestinal disorders | Immediate Voriconazole | 2 | 81 | |
| other | Abdominal pain | Gastrointestinal disorders | Deferred Voriconazole Treatment | 5 | 66 | |
| other | Constipation | Gastrointestinal disorders | Immediate Voriconazole | 7 | 81 | |
| other | Constipation | Gastrointestinal disorders | Deferred Voriconazole Treatment | 3 | 66 | |
| other | Diarrhoea | Gastrointestinal disorders | Immediate Voriconazole | 22 | 81 | |
| other | Diarrhoea | Gastrointestinal disorders | Deferred Voriconazole Treatment | 13 | 66 | |
| other | Nausea | Gastrointestinal disorders | Immediate Voriconazole | 12 | 81 | |
| other | Nausea | Gastrointestinal disorders | Deferred Voriconazole Treatment | 6 | 66 |
1 to 10 of 82Source ClinicalTrials.gov
See all 82 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Immediate Voriconazole | ||
| Total, all-cause mortality | Deferred Voriconazole Treatment | ||
| Total, other adverse events | Immediate Voriconazole | 58 | 81 |
| Total, other adverse events | Deferred Voriconazole Treatment | 38 | 66 |
| Total, serious adverse events | Immediate Voriconazole | 8 | 81 |
| Total, serious adverse events | Deferred Voriconazole Treatment | 8 | 66 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Immediate Voriconazole vs Deferred Voriconazole Treatment: Number of Participants Assessed as Needing Further Antineoplastic Therapy as Planned | Trial comparisons |
| Immediate Voriconazole vs Deferred Voriconazole Treatment: Number of Participants That Died on or Before Day 28 (Mortality) | Trial comparisons |
| Immediate Voriconazole vs Deferred Voriconazole Treatment: Number of Participants With Proven or Probable Invasive Fungal Infections (IFI): Complete Case Analysis | Trial comparisons |
| Immediate Voriconazole vs Deferred Voriconazole Treatment: Number of Participants With Defervescence Day 5 (4 Days After Initiation of Study Treatment) | Trial comparisons |
| Immediate Voriconazole vs Deferred Voriconazole Treatment: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00150345
GET https://conductscience.org/api/trials/v1/NCT00150345/registered?page=2