Trial · NCT04218851
Posaconazole (MK-5592) Intravenous and Oral in Children With Invasive Aspergillosis (IA) (MK-5592-104)
NCT04218851, Phase 2, Completed, Merck Sharp & Dohme LLC; results first posted 2025-01-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Posaconazole (MK-5592) Intravenous and Oral in Children With Invasive Aspergillosis (IA) (MK-5592-104). Trials, record NCT04218851. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04218851
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Posaconazole (MK-5592) Intravenous and Oral in Children With Invasive Aspergillosis (IA) (MK-5592-104)
- NCT number
- NCT04218851
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 31 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Invasive Aspergillosis
- Interventions
- Posaconazole IV, Posaconazole PFS, Posaconazole tablet
- First posted
- 2020-01-06
- Last updated
- 2025-01-14
- Other registries' IDs
- eudract:2019-002267-10
- Results first posted
- 2025-01-14
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Experience One or More Treatment-related Adverse Events (AEs) | Up to 14 days after treatment (up to Day 102) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Treatment-related AEs were determined by the investigator to be related to the drug. The 95% confidence interval (CI) was based on the exact binomial method by Clopper- Pearson. |
| Secondary | Percentage of Participants Who Have a Favorable Global Clinical Response Through Week 6 | Up to week 6 | A global clinical response is assessed by the investigator as favorable if the participant is alive and has a complete response (CR) or partial response (PR). CR is defined as survival within the prespecified period of observation, resolution of all attributable symptoms and signs of disease, resolution of radiological lesion(s), and documented clearance of infected sites that are accessible to repeated sampling. PR is defined as survival within the prespecified period of observation, improvement in attributable symptoms and signs of disease, improvement of radiological lesion(s), and evidence of clearance of infected sites that are accessible to repeated sampling. |
| Secondary | Percentage of Participants Who Have a Favorable Global Clinical Response Through Week 12 | Up to Week 12 | A global clinical response is assessed by the investigator as favorable if the participant is alive and has a complete response (CR) or partial response (PR). CR is defined as survival within the prespecified period of observation, resolution of all attributable symptoms and signs of disease, resolution of radiological lesion(s), and documented clearance of infected sites that are accessible to repeated sampling. PR is defined as survival within the prespecified period of observation, improvement in attributable symptoms and signs of disease, improvement of radiological lesion(s), and evidence of clearance of infected sites that are accessible to repeated sampling. |
| Secondary | Percentage of Participants Who Have a Relapse of Invasive Aspergillosis (IA) at Any Point After Achieving Favorable Global Clinical Response | Up to 28 days post-treatment (up to Day 116) | In participants who achieved favorable global clinical response, relapse of IA is defined as the re-emergence of clinical, radiographic, or other relevant abnormalities indicating IA. |
| Secondary | Average Plasma Concentration (Cavg) of POS by Age Cohorts | Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12 | Steady state Cavg was determined by population PK analysis of plasma concentrations obtained pre-dose up to Week 12 for each of Cohorts 1 and 2, as well as the pooled Cohorts 1 and 2. Some participants had 2 Cavg parameter values (1 for IV dosing, 1 for oral dosing). |
| Secondary | Minimum Plasma Concentration (Cmin) of POS by Age Cohorts | Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12 | Steady state Cmin was determined by population PK analysis of plasma concentrations obtained pre-dose up to Week 12 for each of Cohorts 1 and 2, as well as the pooled Cohorts 1 and 2. Some participants had 2 Cmin parameter values (1 for IV dosing, 1 for oral dosing). |
| Secondary | Maximum Plasma Concentration (Cmax) of POS by Age Cohorts | Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12 | Steady state Cmax was determined by population PK analysis of plasma concentrations obtained pre-dose up to Week 12 for each of Cohorts 1 and 2, as well as the pooled Cohorts 1 and 2. Some participants had 2 Cmax parameter values (1 for IV dosing, 1 for oral dosing). |
| Secondary | Area Under the Concentration Time Curve Over the Dosing Interval (AUCtau) of POS by Age Cohorts | Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12 | Steady state AUCtau was determined by population PK analysis of plasma concentrations obtained pre-dose up to Week 12 for each of Cohorts 1 and 2, as well as the pooled Cohorts 1 and 2. Some participants had 2 AUCtau parameter values (1 for IV dosing, 1 for oral dosing). |
| Secondary | Time to Reach Cmax (Tmax) of POS by Age Cohorts | Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12 | Steady state Tmax was determined by population PK analysis of plasma concentrations obtained pre-dose up to Week 12 for each of Cohorts 1 and 2, as well as the pooled Cohorts 1 and 2. Some participants had 2 Tmax parameter values (1 for IV dosing, 1 for oral dosing). |
| Secondary | Average Plasma Concentration (Cavg) of POS by Formulation | Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12 | Steady-state Cavg was determined by population PK analysis from plasma concentration obtained pre-dose up to Week 12 for each of the POS formulations: IV, PFS and tablet. Some participants may have received more than 1 formulation, and results were only reported when N \> 2. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Experience One or More Treatment-related Adverse Events (AEs) | Up to 14 days after treatment (up to Day 102) | All enrolled participants who received at least 1 dose of study treatment, regardless of their IA classification. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Have a Favorable Global Clinical Response Through Week 6 | Up to week 6 | Participants who have possible, probable, or proven IA; receive at least 1 dose of study treatment; have at least 1 post-allocation observation subsequent to at least 1 dose of study treatment; and have baseline data for those analyses that require baseline data. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Have a Favorable Global Clinical Response Through Week 12 | Up to Week 12 | Participants who have possible, probable, or proven IA; receive at least 1 dose of study treatment; have at least 1 post-allocation observation subsequent to at least 1 dose of study treatment; and have baseline data for those analyses that require baseline data. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Have a Relapse of Invasive Aspergillosis (IA) at Any Point After Achieving Favorable Global Clinical Response | Up to 28 days post-treatment (up to Day 116) | Participants who have possible, probable, or proven IA; receive at least 1 dose of study treatment; have at least 1 post-allocation observation subsequent to at least 1 dose of study treatment; have baseline data for those analyses that require baseline data; and who have achieved a favorable global clinical response at the end of study treatment. | Percentage of participants | NUMBER |
| SECONDARY | Average Plasma Concentration (Cavg) of POS by Age Cohorts | Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12 | All treated participants who had at least 1 postdose plasma concentration obtained after receiving at least 5 days of treatment. Per protocol PK results were analyzed for each age cohort, as well as the pooled age cohorts. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Minimum Plasma Concentration (Cmin) of POS by Age Cohorts | Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12 | All treated participants who had at least 1 postdose plasma concentration obtained after receiving at least 5 days of treatment. Per protocol PK results were analyzed for each age cohort, as well as the pooled age cohorts. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Maximum Plasma Concentration (Cmax) of POS by Age Cohorts | Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12 | All treated participants who had at least 1 postdose plasma concentration obtained after receiving at least 5 days of treatment. Per protocol PK results were analyzed for each age cohort, as well as the pooled age cohorts. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Area Under the Concentration Time Curve Over the Dosing Interval (AUCtau) of POS by Age Cohorts | Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12 | All treated participants who had at least 1 postdose plasma concentration obtained after receiving at least 5 days of treatment. Per protocol PK results were analyzed for each age cohort, as well as the pooled age cohorts. | ng*h/mL | GEOMETRIC_MEAN |
| SECONDARY | Time to Reach Cmax (Tmax) of POS by Age Cohorts | Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12 | All treated participants who had at least 1 postdose plasma concentration obtained after receiving at least 5 days of treatment. Per protocol PK results were analyzed for each age cohort, as well as the pooled age cohorts. | hr. | MEDIAN |
| SECONDARY | Average Plasma Concentration (Cavg) of POS by Formulation | Pre-dose, Day 1, Weeks 1, 2, 4, 6, 9 and 12 | All treated participants who had at least 1 postdose plasma concentration obtained after receiving at least 5 days of treatment. Per protocol PK results were analyzed for each POS formulation. | ng/mL | GEOMETRIC_MEAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group65
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Experience One or More Treatment-related Adverse Events (AEs) | Age Cohort 1 (2 -< 12 Years Old) | 14.3 | 95% Confidence Interval 1.8 | Percentage of participants | |
| Percentage of Participants Who Experience One or More Treatment-related Adverse Events (AEs) | Age Cohort 2 (12 -< 18 Years Old) | 29.4 | 95% Confidence Interval 10.3 | Percentage of participants | |
| Percentage of Participants Who Have a Favorable Global Clinical Response Through Week 6 | Age Cohort 1 (2 -< 12 Years Old) | Success, Complete Response | 42.9 | Percentage of participants | |
| Percentage of Participants Who Have a Favorable Global Clinical Response Through Week 6 | Age Cohort 2 (12 -< 18 Years Old) | Success, Complete Response | 17.6 | Percentage of participants | |
| Percentage of Participants Who Have a Favorable Global Clinical Response Through Week 6 | Age Cohort 1 (2 -< 12 Years Old) | Success, Partial Response | 21.4 | Percentage of participants | |
| Percentage of Participants Who Have a Favorable Global Clinical Response Through Week 6 | Age Cohort 2 (12 -< 18 Years Old) | Success, Partial Response | 52.9 | Percentage of participants | |
| Percentage of Participants Who Have a Favorable Global Clinical Response Through Week 12 | Age Cohort 1 (2 -< 12 Years Old) | Success, Complete Response | 57.1 | Percentage of participants | |
| Percentage of Participants Who Have a Favorable Global Clinical Response Through Week 12 | Age Cohort 2 (12 -< 18 Years Old) | Success, Complete Response | 41.2 | Percentage of participants | |
| Percentage of Participants Who Have a Favorable Global Clinical Response Through Week 12 | Age Cohort 1 (2 -< 12 Years Old) | Success, Partial Response | 21.4 | Percentage of participants | |
| Percentage of Participants Who Have a Favorable Global Clinical Response Through Week 12 | Age Cohort 2 (12 -< 18 Years Old) | Success, Partial Response | 35.3 | Percentage of participants |
1 to 10 of 65Source ClinicalTrials.gov
See all 65 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Age Cohort 1 (2 -< 12 Years Old) | 14 | |
| Overall Study | STARTED | Age Cohort 2 (12 -< 18 Years Old) | 17 | |
| Overall Study | COMPLETED | Age Cohort 1 (2 -< 12 Years Old) | 13 | |
| Overall Study | COMPLETED | Age Cohort 2 (12 -< 18 Years Old) | 14 | |
| Overall Study | NOT COMPLETED | Age Cohort 1 (2 -< 12 Years Old) | 1 | |
| Overall Study | NOT COMPLETED | Age Cohort 2 (12 -< 18 Years Old) | 3 |
Source ClinicalTrials.gov
Adverse events336
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 | Age Cohort 1 (2 -< 12 Years Old) | 0 | 14 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Age Cohort 2 (12 -< 18 Years Old) | 2 | 17 | 3 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Age Cohort 1 (2 -< 12 Years Old) | 1 | 14 | 1 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Age Cohort 2 (12 -< 18 Years Old) | 2 | 17 | 2 |
| other | Lymphocytosis | Blood and lymphatic system disorders | Age Cohort 1 (2 -< 12 Years Old) | 0 | 14 | 0 |
| other | Lymphocytosis | Blood and lymphatic system disorders | Age Cohort 2 (12 -< 18 Years Old) | 1 | 17 | 1 |
| other | Myelosuppression | Blood and lymphatic system disorders | Age Cohort 1 (2 -< 12 Years Old) | 0 | 14 | 0 |
| other | Myelosuppression | Blood and lymphatic system disorders | Age Cohort 2 (12 -< 18 Years Old) | 1 | 17 | 1 |
| other | Neutropenia | Blood and lymphatic system disorders | Age Cohort 1 (2 -< 12 Years Old) | 0 | 14 | 0 |
| other | Neutropenia | Blood and lymphatic system disorders | Age Cohort 2 (12 -< 18 Years Old) | 2 | 17 | 2 |
1 to 10 of 336Source ClinicalTrials.gov
See all 336 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Age Cohort 1 (2 -< 12 Years Old) | 2 | 14 |
| Total, all-cause mortality | Age Cohort 2 (12 -< 18 Years Old) | 4 | 17 |
| Total, other adverse events | Age Cohort 1 (2 -< 12 Years Old) | 12 | 14 |
| Total, other adverse events | Age Cohort 2 (12 -< 18 Years Old) | 14 | 17 |
| Total, serious adverse events | Age Cohort 1 (2 -< 12 Years Old) | 4 | 14 |
| Total, serious adverse events | Age Cohort 2 (12 -< 18 Years Old) | 8 | 17 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41589852 | DERIVED |
Source PubMed
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Age Cohort 1 (2 -< 12 Years Old) vs Age Cohort 2 (12 -< 18 Years Old): deaths from any cause | Trial comparisons |
| Age Cohort 1 (2 -< 12 Years Old) vs Age Cohort 2 (12 -< 18 Years Old): 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.
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