Trial · NCT03816176
A Study to Evaluate Isavuconazonium Sulfate for the Treatment of Invasive Aspergillosis (IA) or Invasive Mucormycosis (IM) in Pediatric Participants
NCT03816176, Phase 2, Completed, Astellas Pharma Global Development, Inc.; results first posted 2023-09-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate Isavuconazonium Sulfate for the Treatment of Invasive Aspergillosis (IA) or Invasive Mucormycosis (IM) in Pediatric Participants. Trials, record NCT03816176. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03816176
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate Isavuconazonium Sulfate for the Treatment of Invasive Aspergillosis (IA) or Invasive Mucormycosis (IM) in Pediatric Participants
- NCT number
- NCT03816176
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 31 participants, actual
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Conditions
- Invasive Mucormycosis, Invasive Aspergillosis
- Interventions
- Isavuconazonium sulfate, Isavuconazonium sulfate
- First posted
- 2019-01-25
- Last updated
- 2024-12-05
- Other registries' IDs
- eudract:2018-003975-36
- Results first posted
- 2023-09-21
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | From first dose to 30 days after the last dose (maximum 210 Days) | An AE is any untoward medical occurrence in a participant administered a study drug, which does not have to have a causal relationship with this treatment. It can be any unfavorable sign, symptom, or disease temporally associated with the use of a medicinal product. TEAE is defined as an AE observed after starting administration of the study drug through 30 days after the last dose. |
| Primary | Percentage of Participants With All - Cause Mortality Through Day 42 | Baseline up to 42 days | All - Cause Mortality Through Day 42 |
| Secondary | Percentage of Participants With All - Cause Mortality | Baseline up to day 84 and end of treatment (EOT) (up to a maximum of 180 days) (Average duration of treatment: 57.7 days) | EOT was defined as anytime from "day 1 to a maximum of day 180". Data reported in the table below for each category, i.e., Day 84 represented data between Day 1 and Day 84 and for EOT, data represented between Day 1 to the EOT day for each individual. Participants who died after EOT assessment but before reaching Day 84 were included in the data for Day 84 category. Only those deaths that occurred after Day 84 would be included in EOT category if the death occurred during the treatment period (i.e. prior to the EOT). |
| Secondary | Percentage of Participants With Overall Response: Adjudication Committee (AC) Assessment | Baseline up to days 42, 84 and EOT (180 days) | Overall response was based on a composite of clinical, mycological, and radiological responses with success criteria assessed. Success criteria as assessed by AC in: Clinical response: * Complete: Resolution of all attributable clinical symptoms and physical findings * Partial: Resolution of at Least some of the clinical symptoms and physical findings associated with IFD Mycological response: * Eradication: No growth of the original (at baseline) causative organism on culture or identified by histology/cytology on post baseline (after day 7) cultures and/or histology/cytology * Presumed eradication: Missing post baseline documentation of eradication of the original causative organism at baseline PLUS resolution of all or some clinical symptoms/physical finding Radiological response: * Complete: ≥ 90% improvement * Partial: At least \< 25% response at day 42 and at least 50% by Day 84 |
| Secondary | Percentage of Participants With Clinical Response: AC Assessment | Baseline up to days 42, 84 and EOT (180 days) | AC Assessed Clinical response was defined as follows: * Success: Complete (if resolution of all attributable clinical symptoms and physical findings occurs); Partial (if resolution of at least some of the clinical symptoms and physical findings associated with IFD) * Failure: Stable (if minor of no change in clinical symptoms and physical findings associated with IFD); Progression (if worsening or new clinical symptoms and physical findings associated with IFD, or if alternative systemic antifungal treatment is required) * Not Evaluable: If not assessed or no clinical signs or symptoms at baseline * No assessment: Those participants that do not fall under any of the above criteria |
| Secondary | Percentage of Participants With Clinical Response: Investigator Assessment | Baseline up to days 42, 84 and EOT (180 days) | Investigator-assessed Clinical Response was defined as follows: * Success: if resolution of all attributable signs and symptoms or resolution of attributable clinical symptoms and physical findings * Failure: if no resolution of any attributable signs and symptoms or no resolution of any attributable signs and symptoms (no change) or worsening of any attributable signs and symptoms * Not Evaluable: if results not available /participant unevaluable or if no attributable signs and symptoms * No assessment: Those participants that do not fall under any of the above criteria |
| Secondary | Percentage of Participants With Radiological Response: AC Assessment | Baseline up to days 42, 84 and EOT (180 days) | AC-assessed Radiological Response was defined as follows: * Success: Complete (if ≥ 90% improvement); Partial (if at least \< 25% response at day 42 and at least 50% response by Day 84) * Failure: Stable (if minor or no change in radiographic abnormalities associated with IFD, but no signs of progression); Progression (if worsening or new radiological abnormalities associated with IRD) * Not Evaluable: if no post baseline radiology available with baseline evidence of radiolical disease Or Radiology not applicable at baseline * No assessment: Those participants that do not fall under any of the above criteria |
| Secondary | Percentage of Participants With Radiological Response: Investigator Assessment | Baseline up to days 42, 84 and EOT (180 days) | Investigator's assessed radiological response was defined as follows: * Success: if ≥ 90% improvement, ≥ 50% to \< 90% improvement, ≥ 25% to 50% improvement (for Day 42 only) * Failure if \< 25% improvement at any time or no signs or radiological Images * Not Evaluable if results not evaluable or no radiological data available * No assessment: Those participants that do not fall under any of the above criteria |
| Secondary | Percentage of Participants With Mycological Response: AC Assessment | Baseline up to days 42, 84 and EOT (180 days) | AC assessed mycological response was defined as follows: * Success: Eradicated (no growth of the original \[at baseline\] causative organism on culture or identified by histology/cytology on post baseline \[after day 7\] cultures and/or histology/cytology); Presumed Eradicated (missing post baseline documentation of eradication of the original causative organism at baseline PLUS resolution of all or some clinical symptoms/physical finding) * Failure: Persistence (persistence of the original causative organism cultured or identified by histological /cytology at baseline); Presumed Persistence (missing post baseline documentation of the persistence of the original causative organism at baseline PLUS no resolution or worsening of any clinical symptoms/physical findings) * Not Evaluable - no mycological evidence * No assessment: Those participants that do not fall under any of the above criteria |
| Secondary | Percentage of Participats With Mycological Response: Investigator Assessment | Baseline up to days 42, 84 and EOT (180 days) | Investigator's assessed mycological response was defined as follows: * Success: Eradicated (no growth of the original \[at baseline\] causative organism on culture or identified by histology/cytology on post baseline \[after day 7\] cultures and/or histology/cytology); Presumed Eradicated (missing post baseline documentation of eradication of the original causative organism at baseline PLUS resolution of all or some clinical symptoms/physical finding) * Failure: Persistence (persistence of the original causative organism cultured or identified by histological /cytology at baseline); Presumed Persistence (missing post baseline documentation of the persistence of the original causative organism at baseline PLUS no resolution or worsening of any clinical symptoms/physical findings) * Not Evaluable: Indeterminate/no mycological follow-up or results available * No assessment: Those participants that do not fall under any of the above criteria |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
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 Emergent Adverse Events (TEAEs) | From first dose to 30 days after the last dose (maximum 210 Days) | The safety analysis set (SAF) consisted of all participant who were enrolled and received at least one dose of study drug. | Participants | NUMBER |
| PRIMARY | Percentage of Participants With All - Cause Mortality Through Day 42 | Baseline up to 42 days | FAS population | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With All - Cause Mortality | Baseline up to day 84 and end of treatment (EOT) (up to a maximum of 180 days) (Average duration of treatment: 57.7 days) | FAS population | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Overall Response: Adjudication Committee (AC) Assessment | Baseline up to days 42, 84 and EOT (180 days) | FAS population | Percentage of partticipants | NUMBER |
| SECONDARY | Percentage of Participants With Clinical Response: AC Assessment | Baseline up to days 42, 84 and EOT (180 days) | FAS population. If participant did not reach Day 42 or Day 84 of therapy then the AC did not perform these assessments. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinical Response: Investigator Assessment | Baseline up to days 42, 84 and EOT (180 days) | FAS population. If participant did not reach Day 42 or Day 84 of therapy then the investigator did not perform these assessments. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Radiological Response: AC Assessment | Baseline up to days 42, 84 and EOT (180 days) | FAS population. If participant did not reach Day 42 or Day 84 of therapy then the AC did not perform these assessments. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Radiological Response: Investigator Assessment | Baseline up to days 42, 84 and EOT (180 days) | FAS population. If participant did not reach Day 42 or Day 84 of therapy then the investigator did not perform these assessments. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Mycological Response: AC Assessment | Baseline up to days 42, 84 and EOT (180 days) | FAS population. If participant did not reach Day 42 or Day 84 of therapy then the AC did not perform these assessments. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participats With Mycological Response: Investigator Assessment | Baseline up to days 42, 84 and EOT (180 days) | FAS population. If participant did not reach Day 42 or Day 84 of therapy then the investigator did not perform these assessments. | Percentage of Participants | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group85
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 Emergent Adverse Events (TEAEs) | Isavuconazonium Sulfate | 29 | Participants | ||
| Percentage of Participants With All - Cause Mortality Through Day 42 | Isavuconazonium Sulfate | 6.5 | 95% Confidence Interval 0.79 to 21.42 | Percentage of participants | |
| Percentage of Participants With All - Cause Mortality | Isavuconazonium Sulfate | Day 84 | 9.7 | 95% Confidence Interval 2.04 to 25.75 | Percentage of participants |
| Percentage of Participants With All - Cause Mortality | Isavuconazonium Sulfate | EOT | 0.00 | 95% Confidence Interval 0.00 to 0.00 | Percentage of participants |
| Percentage of Participants With Overall Response: Adjudication Committee (AC) Assessment | Isavuconazonium Sulfate | Day 42 | 29.0 | Percentage of partticipants | |
| Percentage of Participants With Overall Response: Adjudication Committee (AC) Assessment | Isavuconazonium Sulfate | Day 84 | 25.8 | Percentage of partticipants | |
| Percentage of Participants With Overall Response: Adjudication Committee (AC) Assessment | Isavuconazonium Sulfate | EOT | 54.8 | Percentage of partticipants | |
| Percentage of Participants With Clinical Response: AC Assessment | Isavuconazonium Sulfate | Day 42 Success | 0 | Percentage of participants | |
| Percentage of Participants With Clinical Response: AC Assessment | Isavuconazonium Sulfate | Day 42 Failure | 0 | Percentage of participants | |
| Percentage of Participants With Clinical Response: AC Assessment | Isavuconazonium Sulfate | Day 42 Not Evaluable | 58.06 | Percentage of participants |
1 to 10 of 85Source ClinicalTrials.gov
See all 85 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Isavuconazonium Sulfate | 31 | |
| Overall Study | COMPLETED | Isavuconazonium Sulfate | 19 | |
| Overall Study | NOT COMPLETED | Isavuconazonium Sulfate | 12 |
Source ClinicalTrials.gov
Adverse events85
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 | Isavuconazonium Sulfate | 3 | 31 | 6 |
| other | Lymphopenia | Blood and lymphatic system disorders | Isavuconazonium Sulfate | 3 | 31 | 3 |
| other | Neutropenia | Blood and lymphatic system disorders | Isavuconazonium Sulfate | 2 | 31 | 4 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Isavuconazonium Sulfate | 3 | 31 | 3 |
| other | Tachycardia | Cardiac disorders | Isavuconazonium Sulfate | 3 | 31 | 3 |
| other | Ear pain | Ear and labyrinth disorders | Isavuconazonium Sulfate | 2 | 31 | 3 |
| other | Abdominal distension | Gastrointestinal disorders | Isavuconazonium Sulfate | 3 | 31 | 3 |
| other | Abdominal pain | Gastrointestinal disorders | Isavuconazonium Sulfate | 3 | 31 | 3 |
| other | Aphthous ulcer | Gastrointestinal disorders | Isavuconazonium Sulfate | 4 | 31 | 7 |
| other | Constipation | Gastrointestinal disorders | Isavuconazonium Sulfate | 3 | 31 | 3 |
1 to 10 of 85Source ClinicalTrials.gov
See all 85 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Isavuconazonium Sulfate | 3 | 31 |
| Total, other adverse events | Isavuconazonium Sulfate | 28 | 31 |
| Total, serious adverse events | Isavuconazonium Sulfate | 18 | 31 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39540734 | 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 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.
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/NCT03816176
GET https://conductscience.org/api/trials/v1/NCT03816176/results?page=2