Otomycosis
Conditions
Brief summary
Multicenter, randomized, 2-arm parallel-group, double blind, placebo-controlled study in patients suffering from Otomycosis. This study will compare the efficacy and safety of SVT-15652 otic solution to that of Placebo, when administering one vial twice daily during 14 days.
Interventions
DRUGSVT-15652
1 vial twice daily
DRUGPlacebo
1 vial twice daily
Sponsors
Salvat
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: * At least 18 years of age * Clinical diagnosis of otomycosis in one or both ears, where topical treatment is indicated. * Signs/symptoms of pruritus, otalgia and ear fullness. * Debris or drainage clinically consistent with fungal infection. Main
Exclusion criteria
* Known bacterial otitis externa or malignant otitis externa. * Tympanic perforation, tympanostomy tubes inserted and post mastoid surgery. * Structural ear anomalies which may difficult the evaluation of the therapeutic response. * Uncontrolled diabetes mellitus. * Any infection requiring systemic antimicrobial or systemic antifungal therapy. * Concomitant medicines that may interfere with the study evaluations.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Therapeutic Cure (Clinical and Mycological Cure) | Test of cure on day 24 | Percentage of subjects with therapeutic cure |
Countries
Spain
Participant flow
Recruitment details
The principal investigator was an otolaryngologist.
Pre-assignment details
A fungal culture was performed at baseline to know if subject had an ear infection due to Aspergillus or Candida spp. The main efficacy population of the study was the MITT population (evaluable patients): randomized subjects who had a positive baseline culture for Aspergillus spp and/or Candida spp. From the 194 subjects enrolled in the study, only 110 patients showed positive fungal culture for Aspergillus and/or Candida spp.
Participants by arm
| Arm | Count |
|---|---|
| SVT-15652 Investigational treatment | 75 |
| Placebo Comparator | 35 |
| Total | 110 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | covid pandemic, bacterial ear culture | 2 | 0 |
| Overall Study | Lack of Efficacy | 3 | 5 |
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | SVT-15652 | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 52.8 years STANDARD_DEVIATION 15.5 | 52.4 years STANDARD_DEVIATION 15.53 | 51.5 years STANDARD_DEVIATION 15.78 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 72 Participants | 106 Participants | 34 Participants |
| Region of Enrollment Europe | 75 participants | 110 participants | 35 participants |
| Sex: Female, Male Female | 35 Participants | 50 Participants | 15 Participants |
| Sex: Female, Male Male | 40 Participants | 60 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 127 | 0 / 64 |
| other Total, other adverse events | 0 / 127 | 3 / 64 |
| serious Total, serious adverse events | 0 / 127 | 1 / 64 |
Outcome results
Primary
Therapeutic Cure (Clinical and Mycological Cure)
Percentage of subjects with therapeutic cure
Time frame: Test of cure on day 24
Population: MITT Population: Randomized patients who had positive baseline fungal culture for Aspergillus spp and/or Candida spp
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SVT-15652 | Therapeutic Cure (Clinical and Mycological Cure) | 59 Participants |
| Placebo | Therapeutic Cure (Clinical and Mycological Cure) | 8 Participants |