Trial · NCT00423267
POS vs FLU for First Line Treatment of Coccidioidomycosis (Study P04558Am1)(COMPLETED)
NCT00423267, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2010-06-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. POS vs FLU for First Line Treatment of Coccidioidomycosis (Study P04558Am1)(COMPLETED). Trials, record NCT00423267. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00423267
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- POS vs FLU for First Line Treatment of Coccidioidomycosis (Study P04558Am1)(COMPLETED)
- NCT number
- NCT00423267
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 16 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Coccidioidomycosis
- Interventions
- Posaconazole, Fluconazole
- First posted
- 2007-01-18
- Last updated
- 2017-04-11
- Results first posted
- 2010-06-30
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-related Treatment-emergent Adverse Events (TRAEs) That Occurred With Posaconazole (POS) or Fluconazole (FLU) in Period A | 12 months | Treatment-emergent adverse events are defined as new events that occur following subject entry into the study or events that worsen following study entry state. Treatment-related adverse events are defined as new events that occur following subject entry into the study or events that worsen following study entry state and are judged by the investigator to be possibly, probably or definitely related to study medication. |
| Primary | Number of Participants With Treatment-related Treatment-emergent Adverse Events (TRAEs) That Occurred With Posaconazole (POS) in Period B | 12 months | Treatment-emergent adverse events are defined as new events that occur following subject entry into the study or events that worsen following study entry state. Treatment-related adverse events are defined as new events that occur following subject entry into the study or events that worsen following study entry state and are judged by the investigator to be possibly, probably or definitely related to study medication. |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs)That Occurred With POS or FLU in Period A | 12 months | Treatment-emergent adverse events are defined as new events that occur following subject entry into the study or events that worsen following study entry state. |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) That Occurred With POS in Period B | 12 months | Treatment-emergent adverse events are defined as new events that occur following subject entry into the study or events that worsen following study entry state. |
| Secondary | Number of Participants With Laboratory Test Abnormalities (at Least a 1 Grade Shift From Baseline) That Occurred With POS or FLU in Period A | 12 months | Severity grading was based on Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. This is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE; Grade 2 Moderate AE; Grade 3 Severe AE; Grade 4 Life-threatening or disabling AE; Grade 5 Death related to AE. |
| Secondary | Number of Participants With Laboratory Abnormalities (at Least a 1 Grade Shift From Baseline) That Occurred With POS in Period B | 12 months | Severity grading was based on Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. This is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE; Grade 2 Moderate AE; Grade 3 Severe AE; Grade 4 Life-threatening or disabling AE; Grade 5 Death related to AE. |
| Secondary | Number of Participant Discontinuations Due to Adverse Events and/or Laboratory Evaluations of Safety in Period A | 12 months | |
| Secondary | Number of Participant Discontinuations Due to Adverse Events and/or Laboratory Evaluations of Safety in Period B | 12 months |
Source ClinicalTrials.gov
Outcomes8
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 Treatment-related Treatment-emergent Adverse Events (TRAEs) That Occurred With Posaconazole (POS) or Fluconazole (FLU) in Period A | 12 months | Participants | NUMBER | |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs)That Occurred With POS or FLU in Period A | 12 months | Participants | NUMBER | |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) That Occurred With POS in Period B | 12 months | Participants | NUMBER | |
| SECONDARY | Number of Participants With Laboratory Test Abnormalities (at Least a 1 Grade Shift From Baseline) That Occurred With POS or FLU in Period A | 12 months | Participants | NUMBER | |
| PRIMARY | Number of Participants With Treatment-related Treatment-emergent Adverse Events (TRAEs) That Occurred With Posaconazole (POS) in Period B | 12 months | Participants | NUMBER | |
| SECONDARY | Number of Participants With Laboratory Abnormalities (at Least a 1 Grade Shift From Baseline) That Occurred With POS in Period B | 12 months | Participants | NUMBER | |
| SECONDARY | Number of Participant Discontinuations Due to Adverse Events and/or Laboratory Evaluations of Safety in Period A | 12 months | Participants | NUMBER | |
| SECONDARY | Number of Participant Discontinuations Due to Adverse Events and/or Laboratory Evaluations of Safety in Period B | 12 months | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group21
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 Treatment-related Treatment-emergent Adverse Events (TRAEs) That Occurred With Posaconazole (POS) or Fluconazole (FLU) in Period A | Posaconazole | 5 | Participants | ||
| Number of Participants With Treatment-related Treatment-emergent Adverse Events (TRAEs) That Occurred With Posaconazole (POS) or Fluconazole (FLU) in Period A | Fluconazole | 3 | Participants | ||
| Number of Participants With Treatment-emergent Adverse Events (TEAEs)That Occurred With POS or FLU in Period A | Posaconazole | 8 | Participants | ||
| Number of Participants With Treatment-emergent Adverse Events (TEAEs)That Occurred With POS or FLU in Period A | Fluconazole | 5 | Participants | ||
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) That Occurred With POS in Period B | Posaconazole | 8 | Participants | ||
| Number of Participants With Laboratory Test Abnormalities (at Least a 1 Grade Shift From Baseline) That Occurred With POS or FLU in Period A | Posaconazole | Hematology | 4 | Participants | |
| Number of Participants With Laboratory Test Abnormalities (at Least a 1 Grade Shift From Baseline) That Occurred With POS or FLU in Period A | Fluconazole | Hematology | 1 | Participants | |
| Number of Participants With Laboratory Test Abnormalities (at Least a 1 Grade Shift From Baseline) That Occurred With POS or FLU in Period A | Posaconazole | Liver function tests | 4 | Participants | |
| Number of Participants With Laboratory Test Abnormalities (at Least a 1 Grade Shift From Baseline) That Occurred With POS or FLU in Period A | Fluconazole | Liver function tests | 3 | Participants | |
| Number of Participants With Laboratory Test Abnormalities (at Least a 1 Grade Shift From Baseline) That Occurred With POS or FLU in Period A | Posaconazole | Renal function tests | 0 | Participants |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period A | STARTED | Posaconazole | 9 | |
| Period A | STARTED | Fluconazole | 7 | |
| Period A | COMPLETED | Posaconazole | 7 | |
| Period A | COMPLETED | Fluconazole | 6 | |
| Period A | NOT COMPLETED | Posaconazole | 2 | |
| Period A | NOT COMPLETED | Fluconazole | 1 | |
| Period B | STARTED | Posaconazole | 12 | |
| Period B | STARTED | Fluconazole | 0 | |
| Period B | COMPLETED | Posaconazole | 12 | |
| Period B | COMPLETED | Fluconazole | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events222
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 | ANAEMIA | Blood and lymphatic system disorders | Posaconazole Period A | 1 | 9 | 1 |
| other | ANAEMIA | Blood and lymphatic system disorders | Fluconazole Period A | 0 | 7 | 0 |
| other | ANAEMIA | Blood and lymphatic system disorders | Posaconazole Period B | 0 | 12 | 0 |
| other | BRADYCARDIA | Cardiac disorders | Posaconazole Period A | 1 | 9 | 1 |
| other | BRADYCARDIA | Cardiac disorders | Fluconazole Period A | 0 | 7 | 0 |
| other | BRADYCARDIA | Cardiac disorders | Posaconazole Period B | 0 | 12 | 0 |
| other | PALPITATIONS | Cardiac disorders | Posaconazole Period A | 1 | 9 | 1 |
| other | PALPITATIONS | Cardiac disorders | Fluconazole Period A | 1 | 7 | 1 |
| other | PALPITATIONS | Cardiac disorders | Posaconazole Period B | 0 | 12 | 0 |
| other | DEAFNESS | Ear and labyrinth disorders | Posaconazole Period A | 0 | 9 | 0 |
1 to 10 of 222Source ClinicalTrials.gov
See all 222 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Posaconazole Period A | ||
| Total, all-cause mortality | Fluconazole Period A | ||
| Total, all-cause mortality | Posaconazole Period B | ||
| Total, other adverse events | Posaconazole Period A | 8 | 9 |
| Total, other adverse events | Fluconazole Period A | 5 | 7 |
| Total, other adverse events | Posaconazole Period B | 8 | 12 |
| Total, serious adverse events | Posaconazole Period A | 0 | 9 |
| Total, serious adverse events | Fluconazole Period A | 0 | 7 |
| Total, serious adverse events | Posaconazole Period B | 1 | 12 |
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Posaconazole vs Fluconazole: Number of Participants With Treatment-emergent Adverse Events (TEAEs)That Occurred With POS or FLU in Period A | Trial comparisons |
| Posaconazole vs Fluconazole: Number of Participant Discontinuations Due to Adverse Events and/or Laboratory Evaluations of Safety in Period A | Trial comparisons |
| Posaconazole vs Fluconazole: Number of Participants With Treatment-related Treatment-emergent Adverse Events (TRAEs) That Occurred With Posaconazole (POS) or Fluconazole (FLU) in Period A | 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/NCT00423267
GET https://conductscience.org/api/trials/v1/NCT00423267/results?page=2