Trial · NCT01165320
A Study of Caspofungin (MK-0991) in Japanese Children and Adolescents With Documented Candida or Aspergillus Infections (MK-0991-074)
NCT01165320, Phase 2, Completed, Merck Sharp & Dohme LLC; results first posted 2014-04-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Caspofungin (MK-0991) in Japanese Children and Adolescents With Documented Candida or Aspergillus Infections (MK-0991-074). Trials, record NCT01165320. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01165320
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Caspofungin (MK-0991) in Japanese Children and Adolescents With Documented Candida or Aspergillus Infections (MK-0991-074)
- NCT number
- NCT01165320
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 20 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Candidiasis, Esophageal, Candidiasis, Invasive, Aspergillosis
- Interventions
- Caspofungin
- First posted
- 2010-07-19
- Last updated
- 2018-08-27
- Results first posted
- 2014-04-23
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With an Overall Favorable Response to Therapy | Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days | Invasive candidiasis: favorable overall response required resolved clinical findings and negative culture test for Candida species on follow-up. If Candida species were not observed in the baseline blood culture, favorable overall response required resolved clinical findings and resolved or improved radiographic findings. Aspergillosis: favorable overall response required resolved, improved, or unchanged clinical findings and resolved or improved radiographic findings, or resolved or improved clinical findings and resolved, improved, or stable radiographic findings. |
| Primary | Percentage of Participants With One or More Drug-Related Adverse Experiences | Invasive candidiasis: up to 70 days; aspergillosis: up to 98 days | An adverse experience (AE) is defined as any unfavorable or unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an AE. A drug-related AE is one judged to be definitely, probably, or possibly related to the study drug. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With an Overall Favorable Response to Therapy | Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days | The full analysis set included all enrolled participants who received \>=1 dose of study drug. No participants with esophageal candidiasis were identified for inclusion in the study and assessment for response to therapy. Participants whose overall response assessment was unable to judge were counted as having an unfavorable response. | Percentage of Participants | NUMBER |
| PRIMARY | Percentage of Participants With One or More Drug-Related Adverse Experiences | Invasive candidiasis: up to 70 days; aspergillosis: up to 98 days | The full analysis set included all enrolled participants who received \>=1 dose of study drug. No participants with esophageal candidiasis were identified for inclusion in the study and assessment for safety outcomes. | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With an Overall Favorable Response to Therapy | Participants With Invasive Candidiasis | 66.7 | Percentage of Participants | ||
| Percentage of Participants With an Overall Favorable Response to Therapy | Participants With Aspergillosis | 62.5 | Percentage of Participants | ||
| Percentage of Participants With One or More Drug-Related Adverse Experiences | Participants With Invasive Candidiasis | 58.3 | Percentage of Participants | ||
| Percentage of Participants With One or More Drug-Related Adverse Experiences | Participants With Aspergillosis | 37.5 | Percentage of Participants |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Participants With Invasive Candidiasis | 12 | |
| Overall Study | STARTED | Participants With Aspergillosis | 8 | |
| Overall Study | STARTED | Participants With Esophageal Candidiasis | 0 | |
| Overall Study | COMPLETED | Participants With Invasive Candidiasis | 9 | |
| Overall Study | COMPLETED | Participants With Aspergillosis | 4 | |
| Overall Study | COMPLETED | Participants With Esophageal Candidiasis | 0 | |
| Overall Study | NOT COMPLETED | Participants With Invasive Candidiasis | 3 | |
| Overall Study | NOT COMPLETED | Participants With Aspergillosis | 4 | |
| Overall Study | NOT COMPLETED | Participants With Esophageal Candidiasis | 0 |
Source ClinicalTrials.gov
Adverse events96
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 | Participants With Invasive Candidiasis | 1 | 12 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Participants With Aspergillosis | 0 | 8 | 0 |
| other | Bone Marrow Failure | Blood and lymphatic system disorders | Participants With Invasive Candidiasis | 1 | 12 | 1 |
| other | Bone Marrow Failure | Blood and lymphatic system disorders | Participants With Aspergillosis | 0 | 8 | 0 |
| other | Febrile Neutropenia | Blood and lymphatic system disorders | Participants With Invasive Candidiasis | 1 | 12 | 1 |
| other | Febrile Neutropenia | Blood and lymphatic system disorders | Participants With Aspergillosis | 0 | 8 | 0 |
| other | Ocular Icterus | Eye disorders | Participants With Invasive Candidiasis | 1 | 12 | 1 |
| other | Ocular Icterus | Eye disorders | Participants With Aspergillosis | 0 | 8 | 0 |
| other | Abdominal Discomfort | Gastrointestinal disorders | Participants With Invasive Candidiasis | 1 | 12 | 1 |
| other | Abdominal Discomfort | Gastrointestinal disorders | Participants With Aspergillosis | 0 | 8 | 0 |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Participants With Invasive Candidiasis | ||
| Total, all-cause mortality | Participants With Aspergillosis | ||
| Total, other adverse events | Participants With Invasive Candidiasis | 10 | 12 |
| Total, other adverse events | Participants With Aspergillosis | 5 | 8 |
| Total, serious adverse events | Participants With Invasive Candidiasis | 1 | 12 |
| Total, serious adverse events | Participants With Aspergillosis | 2 | 8 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25701307 | RESULT |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Participants With Invasive Candidiasis vs Participants With Aspergillosis: serious adverse events |
Source 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/NCT01165320
GET https://conductscience.org/api/trials/v1/NCT01165320/events?page=2