Fungal Infection
Conditions
Brief summary
The purpose of this study is to investigate the safety and efficacy of MK0991 in patients with deep-seated mycoses.
Interventions
Caspofungin acetate (50 mg/day for participants with esophageal candidiasis and 50 mg/day for participants with invasive candidiasis or aspergillosis after a 70 mg loading dose on Day 1), once daily intravenously (IV) for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
DRUGComparator: Micafungin sodium
Micafungin sodium 150 mg/day, once daily IV, for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Japanese Patients In Whom A Causative Fungus Is Detected Before Treatment With The Study Drug Or Patients With Strongly Suspected Deep-Seated Fungal Infection Due To Candida species (Spp.) Or Aspergillus Spp.
Exclusion criteria
* Patients With Mycoses Other Than Ones Due To Candida Spp. Or Aspergillus Spp. * Patients Who Will Receive Other Systemic Antifungal Agents For The First Time In Screening Period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Significant Drug-related Adverse Experience | 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis | A significant drug-related adverse experience was defined as a serious drug-related adverse experience or a drug-related adverse experience leading to study therapy discontinuation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Specific Safety Finding | 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis | A specific safety finding was defined as a drug-related adverse experience, a serious drug-related adverse experience, or a drug-related adverse experience leading to study therapy discontinuation. |
| Number of Participants With Favorable Overall Response at the End of Study Therapy | 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis | Favorable overall response for each infection category of deep-seated fungal infections was based on the determination of the Independent Efficacy Assessment Committee. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Caspofungin Caspofungin acetate (50 mg/day for participants with esophageal candidiasis and 50 mg/day for participants with invasive candidiasis or aspergillosis after a 70 mg loading dose on Day 1), once daily intravenously (IV) for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis. | 61 |
| Micafungin Micafungin sodium 150 mg/day, once daily IV for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis. | 60 |
| Total | 121 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Clinical adverse experience | 5 | 9 |
| Overall Study | Discontinued for other reason | 6 | 1 |
| Overall Study | Laboratory adverse experience | 2 | 2 |
| Overall Study | Lack of Efficacy | 7 | 13 |
| Overall Study | Withdrew consent | 7 | 3 |
Baseline characteristics
| Characteristic | Caspofungin | Micafungin | Total |
|---|---|---|---|
| Age, Continuous | 68.9 years STANDARD_DEVIATION 11.2 | 69.3 years STANDARD_DEVIATION 9 | 69.1 years STANDARD_DEVIATION 10.1 |
| Sex: Female, Male Female | 11 Participants | 14 Participants | 25 Participants |
| Sex: Female, Male Male | 50 Participants | 46 Participants | 96 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 44 / 60 | 40 / 60 |
| serious Total, serious adverse events | 12 / 60 | 14 / 60 |
Outcome results
Primary
Number of Participants With a Significant Drug-related Adverse Experience
A significant drug-related adverse experience was defined as a serious drug-related adverse experience or a drug-related adverse experience leading to study therapy discontinuation.
Time frame: 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis
Population: All Participants as Treated (APaT) population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Caspofungin | Number of Participants With a Significant Drug-related Adverse Experience | 3 Participants |
| Micafungin | Number of Participants With a Significant Drug-related Adverse Experience | 6 Participants |
Secondary
Number of Participants With a Specific Safety Finding
A specific safety finding was defined as a drug-related adverse experience, a serious drug-related adverse experience, or a drug-related adverse experience leading to study therapy discontinuation.
Time frame: 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis
Population: APaT population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Caspofungin | Number of Participants With a Specific Safety Finding | Drug-related adverse experience | 23 Participants |
| Caspofungin | Number of Participants With a Specific Safety Finding | Serious drug-related adverse experience | 0 Participants |
| Caspofungin | Number of Participants With a Specific Safety Finding | Discontinued by drug-related adverse experience | 3 Participants |
| Micafungin | Number of Participants With a Specific Safety Finding | Drug-related adverse experience | 25 Participants |
| Micafungin | Number of Participants With a Specific Safety Finding | Serious drug-related adverse experience | 2 Participants |
| Micafungin | Number of Participants With a Specific Safety Finding | Discontinued by drug-related adverse experience | 6 Participants |
Secondary
Number of Participants With Favorable Overall Response at the End of Study Therapy
Favorable overall response for each infection category of deep-seated fungal infections was based on the determination of the Independent Efficacy Assessment Committee.
Time frame: 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis
Population: Per Protocol Set (PPS) population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Caspofungin | Number of Participants With Favorable Overall Response at the End of Study Therapy | Esophageal candidiasis (n=6, n=6) | 6 Participants |
| Caspofungin | Number of Participants With Favorable Overall Response at the End of Study Therapy | Invasive candidiasis (n=3, n=1) | 3 Participants |
| Caspofungin | Number of Participants With Favorable Overall Response at the End of Study Therapy | Aspergillosis (n=30, n=33) | 14 Participants |
| Micafungin | Number of Participants With Favorable Overall Response at the End of Study Therapy | Esophageal candidiasis (n=6, n=6) | 5 Participants |
| Micafungin | Number of Participants With Favorable Overall Response at the End of Study Therapy | Invasive candidiasis (n=3, n=1) | 1 Participants |
| Micafungin | Number of Participants With Favorable Overall Response at the End of Study Therapy | Aspergillosis (n=30, n=33) | 14 Participants |