Trial · NCT02180165
Assessing the Safety and Efficacy of MK-5592 (Posaconazole) in Japanese Participants With Fungal Infection (MK-5592-101)
NCT02180165, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2019-01-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Assessing the Safety and Efficacy of MK-5592 (Posaconazole) in Japanese Participants With Fungal Infection (MK-5592-101). Trials, record NCT02180165. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02180165
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Assessing the Safety and Efficacy of MK-5592 (Posaconazole) in Japanese Participants With Fungal Infection (MK-5592-101)
- NCT number
- NCT02180165
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 116 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Aspergillosis
- Interventions
- Posaconazole, Voriconazole
- First posted
- 2014-07-02
- Last updated
- 2021-01-28
- Results first posted
- 2019-01-11
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With an Adverse Event | Up to approximately Day 98 | An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the Sponsor's product is also an AE. |
| Secondary | Percentage of Participants With Successful Overall Response for Invasive Aspergillosis in Cohort 2 at Day 42 | Day 42 | Successful treatment (or successful overall response) is defined as complete response and partial response to treatment assessed by the clinical adjudication committee (CAC). The 95% confidence interval (CI) is based on the Clopper-Pearson exact method. |
| Secondary | Percentage of Participants With Successful Overall Response for Invasive Aspergillosis in Cohort 2 at Day 84 | Day 84 | Successful treatment (or successful overall response) is defined as complete response and partial response to treatment assessed by CAC. The 95% CI is based on the Clopper-Pearson exact method. |
| Secondary | Percentage of Participants With Successful Overall Response for Chronic Pulmonary Aspergillosis in Cohort 2 at Day 42 | Day 42 | Successful treatment (or successful overall response) is defined as favorable response to treatment assessed by CAC. The 95% CI is based on the Clopper-Pearson exact method. |
| Secondary | Percentage of Participants With Successful Overall Response for Chronic Pulmonary Aspergillosis in Cohort 2 at Day 84 | Day 84 | Successful treatment (or successful overall response) is defined as favorable response to treatment assessed by CAC. The 95% CI is based on the Clopper-Pearson exact method. |
| Secondary | Percentage of Participants With Successful Overall Response for Invasive Aspergillosis and Chronic Pulmonary Aspergillosis in Cohort 2 at End of Trial (Day 84) | Day 84 | Successful treatment (or successful overall response) for invasive aspergillosis is defined as complete response and partial response to treatment assessed by CAC. Successful treatment (or successful overall response) for chronic pulmonary aspergillosis is defined as favorable response to treatment.The 95% CI is based on the Clopper-Pearson exact method. |
| Secondary | Percentage of Participants With Successful Overall Response for Zygomycosis in Cohort 2 at Day 42 | Day 42 | Zygomycosis is an infection caused by zygomycete fungi. Successful treatment (or successful overall response) is defined as complete response and partial response to treatment assessed by CAC. The 95% CI is based on the Clopper-Pearson exact method. |
| Secondary | Percentage of Participants With Successful Overall Response for Zygomycosis in Cohort 2 at Day 84 | Day 84 | Zygomycosis is an infection caused by zygomycete fungi. Successful treatment (or successful overall response) is defined as complete response and partial response to treatment assessed by CAC. The 95% CI is based on the Clopper-Pearson exact method. |
| Secondary | Percentage of Participants With Successful Overall Response for Invasive Aspergillosis in Cohort 2 at Day 42 as Assessed by the Clinical Investigator | Day 42 | Successful treatment (or successful overall response) for invasive aspergillosis is defined as complete response and partial response to treatment assessed by the clinical investigator.The 95% CI is based on the Clopper-Pearson exact method. |
| Secondary | Percentage of Participants With Successful Overall Response for Chronic Pulmonary Aspergillosis in Cohort 2 at Day 84 as Assessed by the Clinical Investigator | Day 84 | Successful treatment (or successful overall response) for chronic pulmonary aspergillosis is defined as favorable response to treatment assessed by the clinical investigator.The 95% CI is based on the Clopper-Pearson exact method. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
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 an Adverse Event | Up to approximately Day 98 | Cohort 1: All randomized participants with chronic pulmonary aspergillosis who received at least one dose of study treatment. Cohort 2: All randomized participants with invasive aspergillosis and chronic pulmonary aspergillosis who received at least one dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Successful Overall Response for Invasive Aspergillosis in Cohort 2 at Day 42 | Day 42 | Participants in cohort 2 diagnosed by CAC with proven or probable invasive aspergillosis; who received at least one dose of study treatment; and had a baseline observation for the analysis endpoint. Participants in cohort 1 were not analyzed for this outcome measure. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Successful Overall Response for Invasive Aspergillosis in Cohort 2 at Day 84 | Day 84 | Participants in cohort 2 diagnosed by CAC with proven or probable invasive aspergillosis; who received at least one dose of study treatment; and had a baseline observation for the analysis endpoint. Participants in cohort 1 were not analyzed for this outcome measure. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Successful Overall Response for Chronic Pulmonary Aspergillosis in Cohort 2 at Day 42 | Day 42 | Participants in cohort 2 diagnosed by CAC with proven or probable chronic pulmonary aspergillosis; who received at least one dose of study treatment; and had a baseline observation for the analysis endpoint. Participants in cohort 1 were not analyzed for this outcome measure. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Successful Overall Response for Chronic Pulmonary Aspergillosis in Cohort 2 at Day 84 | Day 84 | Participants in cohort 2 diagnosed by CAC with proven or probable chronic pulmonary aspergillosis; who received at least one dose of study treatment; and had a baseline observation for the analysis endpoint. Participants in cohort 1 were not analyzed for this outcome measure. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Successful Overall Response for Invasive Aspergillosis and Chronic Pulmonary Aspergillosis in Cohort 2 at End of Trial (Day 84) | Day 84 | Participants in cohort 2 diagnosed by CAC with proven or probable invasive aspergillosis or chronic pulmonary aspergillosis; who received at least one dose of study treatment; and had a baseline observation for the analysis endpoint. Participants in cohort 1 were not analyzed for this outcome measure. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Successful Overall Response for Zygomycosis in Cohort 2 at Day 42 | Day 42 | Participants in cohort 2, posaconazole treatment only, diagnosed by CAC with proven or probable zygomycosis; who received at least one dose of study treatment; and had a baseline observation for the analysis endpoint. Participants in cohort 1, and cohort 2 voriconazole treatment were not analyzed for this outcome measure. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Successful Overall Response for Zygomycosis in Cohort 2 at Day 84 | Day 84 | Participants in cohort 2, posaconazole treatment only, diagnosed by CAC with proven or probable zygomycosis; who received at least one dose of study treatment; and had a baseline observation for the analysis endpoint. Participants in cohort 1, and cohort 2 voriconazole treatment were not analyzed for this outcome measure. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Successful Overall Response for Invasive Aspergillosis in Cohort 2 at Day 42 as Assessed by the Clinical Investigator | Day 42 | Participants in cohort 2 diagnosed by CAC with proven or probable invasive aspergillosis; who received at least one dose of study treatment; and had a baseline observation for the analysis endpoint. Participants in cohort 1 were not analyzed for this outcome measure. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Successful Overall Response for Chronic Pulmonary Aspergillosis in Cohort 2 at Day 84 as Assessed by the Clinical Investigator | Day 84 | Participants in cohort 2 diagnosed by CAC with proven or probable chronic pulmonary aspergillosis; who received at least one dose of study treatment; and had a baseline observation for the analysis endpoint. Participants in cohort 1 were not analyzed for this outcome measure. | Percentage of participants | NUMBER |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group48
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 an Adverse Event | Cohort 1: Posaconazole | 15 | Participants | ||
| Number of Participants With an Adverse Event | Cohort 1: Voriconazole | 6 | Participants | ||
| Number of Participants With an Adverse Event | Cohort 2: Posaconazole | 57 | Participants | ||
| Number of Participants With an Adverse Event | Cohort 2: Voriconazole | 27 | Participants | ||
| Percentage of Participants With Successful Overall Response for Invasive Aspergillosis in Cohort 2 at Day 42 | Cohort 2: Posaconazole | 40.0 | 95% Confidence Interval 5.3 to 85.3 | Percentage of participants | |
| Percentage of Participants With Successful Overall Response for Invasive Aspergillosis in Cohort 2 at Day 42 | Cohort 2: Voriconazole | 100 | 95% Confidence Interval 29.2 to 100 | Percentage of participants | |
| Percentage of Participants With Successful Overall Response for Invasive Aspergillosis in Cohort 2 at Day 84 | Cohort 2: Posaconazole | 60.0 | 95% Confidence Interval 14.7 to 94.7 | Percentage of participants | |
| Percentage of Participants With Successful Overall Response for Invasive Aspergillosis in Cohort 2 at Day 84 | Cohort 2: Voriconazole | 100 | 95% Confidence Interval 29.2 to 100 | Percentage of participants | |
| Percentage of Participants With Successful Overall Response for Chronic Pulmonary Aspergillosis in Cohort 2 at Day 42 | Cohort 2: Posaconazole | 56.3 | 95% Confidence Interval 41.2 to 70.5 | Percentage of participants | |
| Percentage of Participants With Successful Overall Response for Chronic Pulmonary Aspergillosis in Cohort 2 at Day 42 | Cohort 2: Voriconazole | 87.0 | 95% Confidence Interval 66.4 to 97.2 | Percentage of participants |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1: Posaconazole | 15 | |
| Overall Study | STARTED | Cohort 1: Voriconazole | 7 | |
| Overall Study | STARTED | Cohort 2: Posaconazole | 63 | |
| Overall Study | STARTED | Cohort 2: Voriconazole | 31 | |
| Overall Study | Treated Participants | Cohort 1: Posaconazole | 15 | |
| Overall Study | Treated Participants | Cohort 1: Voriconazole | 7 | |
| Overall Study | Treated Participants | Cohort 2: Posaconazole | 62 | |
| Overall Study | Treated Participants | Cohort 2: Voriconazole | 31 | |
| Overall Study | Type of Aspergillosis | Cohort 1: Posaconazole | 15 | |
| Overall Study | Type of Aspergillosis | Cohort 1: Voriconazole | 7 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events452
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 | Cohort 1: Posaconazole | 0 | 15 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 1: Voriconazole | 0 | 7 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 2: Posaconazole | 2 | 62 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 2: Voriconazole | 2 | 31 | 2 |
| other | Eosinophilia | Blood and lymphatic system disorders | Cohort 1: Posaconazole | 1 | 15 | 1 |
| other | Eosinophilia | Blood and lymphatic system disorders | Cohort 1: Voriconazole | 0 | 7 | 0 |
| other | Eosinophilia | Blood and lymphatic system disorders | Cohort 2: Posaconazole | 0 | 62 | 0 |
| other | Eosinophilia | Blood and lymphatic system disorders | Cohort 2: Voriconazole | 0 | 31 | 0 |
| other | Blepharitis | Eye disorders | Cohort 1: Posaconazole | 1 | 15 | 1 |
| other | Blepharitis | Eye disorders | Cohort 1: Voriconazole | 0 | 7 | 0 |
1 to 10 of 452Source ClinicalTrials.gov
See all 452 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1: Posaconazole | 1 | 15 |
| Total, all-cause mortality | Cohort 1: Voriconazole | 1 | 7 |
| Total, all-cause mortality | Cohort 2: Posaconazole | 6 | 62 |
| Total, all-cause mortality | Cohort 2: Voriconazole | 0 | 31 |
| Total, other adverse events | Cohort 1: Posaconazole | 15 | 15 |
| Total, other adverse events | Cohort 1: Voriconazole | 6 | 7 |
| Total, other adverse events | Cohort 2: Posaconazole | 58 | 62 |
| Total, other adverse events | Cohort 2: Voriconazole | 31 | 31 |
| Total, serious adverse events | Cohort 1: Posaconazole | 3 | 15 |
| Total, serious adverse events | Cohort 1: Voriconazole | 2 | 7 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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