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 |
|---|---|---|
| Therapeutical Cure (Clinical and Mycological Cure) | Test of cure on day 24 | Number and percentage of subjects with therapeutic cure |
Countries
United States
Participant flow
Recruitment details
The principal investigator was an otolaryngologist
Pre-assignment details
A fungal culture was performed at baseline to know if the subject has an ear infection due to Aspergillus and/or Candida spp. The main efficacy population of the study was the MITT population (evaluable patients): randomized subjects who have positive baseline culture for Aspergillus and/or Candida spp. From the 217 subjects enrolled, 202 were treated and included in the safety population. Only 118 patients showed positive fungal culture for Aspergillus and/or Candida spp (MITT population).
Participants by arm
| Arm | Count |
|---|---|
| SVT-15652 Investigational treatment
1 vial twice daily | 82 |
| Placebo Comparator
1 vial twice daily | 36 |
| Total | 118 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of Efficacy | 4 | 13 |
| Overall Study | Lost to Follow-up | 3 | 0 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Took prohibited medication | 0 | 1 |
Baseline characteristics
| Characteristic | SVT-15652 | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 53.0 years STANDARD_DEVIATION 17.53 | 53.4 years STANDARD_DEVIATION 19.91 | 53.1 years STANDARD_DEVIATION 18.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 4 Participants | 13 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 3 Participants | 7 Participants |
| Race (NIH/OMB) White | 63 Participants | 26 Participants | 89 Participants |
| Region of Enrollment Mexico | 6 participants | 4 participants | 10 participants |
| Region of Enrollment United States | 76 participants | 32 participants | 108 participants |
| Sex: Female, Male Female | 40 Participants | 15 Participants | 55 Participants |
| Sex: Female, Male Male | 42 Participants | 21 Participants | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 134 | 0 / 68 |
| other Total, other adverse events | 5 / 134 | 4 / 68 |
| serious Total, serious adverse events | 0 / 134 | 0 / 68 |
Outcome results
Primary
Therapeutical Cure (Clinical and Mycological Cure)
Number and 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 | Therapeutical Cure (Clinical and Mycological Cure) | 48 Participants |
| Placebo | Therapeutical Cure (Clinical and Mycological Cure) | 10 Participants |