Trial Outcomes & Findings for SVT-15652 Otic Solution for the Treatment of Otomycosis. (NCT NCT03686397)

NCT ID: NCT03686397

Last Updated: 2022-12-15

Results Overview

Percentage of subjects with therapeutic cure

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 194 participants
• Primary outcome timeframe: Test of cure on day 24
• Results posted on: 2022-12-15

Participant Flow

The principal investigator was an otolaryngologist.

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.

Participant milestones

Measure	SVT-15652 Investigational treatment	Placebo Comparator
Overall Study STARTED	75	35
Overall Study COMPLETED	70	27
Overall Study NOT COMPLETED	5	8

Reasons for withdrawal

Measure	SVT-15652 Investigational treatment	Placebo Comparator
Overall Study Protocol Violation	0	1
Overall Study Lack of Efficacy	3	5
Overall Study Adverse Event	0	1
Overall Study Withdrawal by Subject	0	1
Overall Study covid pandemic, bacterial ear culture	2	0

Baseline Characteristics

SVT-15652 Otic Solution for the Treatment of Otomycosis.

Baseline characteristics by cohort

Measure	SVT-15652 n=75 Participants Investigational treatment	Placebo n=35 Participants Comparator	Total n=110 Participants Total of all reporting groups
Age, Continuous	52.8 years STANDARD_DEVIATION 15.50 • n=93 Participants	51.5 years STANDARD_DEVIATION 15.78 • n=4 Participants	52.4 years STANDARD_DEVIATION 15.53 • n=27 Participants
Sex: Female, Male Female	35 Participants n=93 Participants	15 Participants n=4 Participants	50 Participants n=27 Participants
Sex: Female, Male Male	40 Participants n=93 Participants	20 Participants n=4 Participants	60 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) White	72 Participants n=93 Participants	34 Participants n=4 Participants	106 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Region of Enrollment Europe	75 participants n=93 Participants	35 participants n=4 Participants	110 participants n=27 Participants

PRIMARY outcome

Timeframe: Test of cure on day 24

Population: MITT Population: Randomized patients who had positive baseline fungal culture for Aspergillus spp and/or Candida spp

Percentage of subjects with therapeutic cure

Outcome measures

Measure	SVT-15652 n=75 Participants Investigational treatment	Placebo n=35 Participants Comparator
Therapeutic Cure (Clinical and Mycological Cure)	59 Participants	8 Participants

Adverse Events

SVT-15652

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	SVT-15652 n=127 participants at risk Investigational treatment	Placebo n=64 participants at risk Comparator
Infections and infestations Labyrinthitis	0.00% 0/127 • Overall study period (about 4 weeks) If pre-existing signs and symptoms of otomycosis worsen during the study, this was considered a treatment failure instead of an adverse event. The adverse events were reviewed in the safety population which included subjects who received at least 1 dose of study medication (subjects could have positive or negative fungal culture at baseline because the results of baseline culture were not available until a few days after starting the study treatment).	1.6% 1/64 • Number of events 1 • Overall study period (about 4 weeks) If pre-existing signs and symptoms of otomycosis worsen during the study, this was considered a treatment failure instead of an adverse event. The adverse events were reviewed in the safety population which included subjects who received at least 1 dose of study medication (subjects could have positive or negative fungal culture at baseline because the results of baseline culture were not available until a few days after starting the study treatment).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholesteatoma	0.00% 0/127 • Overall study period (about 4 weeks) If pre-existing signs and symptoms of otomycosis worsen during the study, this was considered a treatment failure instead of an adverse event. The adverse events were reviewed in the safety population which included subjects who received at least 1 dose of study medication (subjects could have positive or negative fungal culture at baseline because the results of baseline culture were not available until a few days after starting the study treatment).	1.6% 1/64 • Number of events 1 • Overall study period (about 4 weeks) If pre-existing signs and symptoms of otomycosis worsen during the study, this was considered a treatment failure instead of an adverse event. The adverse events were reviewed in the safety population which included subjects who received at least 1 dose of study medication (subjects could have positive or negative fungal culture at baseline because the results of baseline culture were not available until a few days after starting the study treatment).

Other adverse events

Measure	SVT-15652 n=127 participants at risk Investigational treatment	Placebo n=64 participants at risk Comparator
Nervous system disorders Dizziness	0.00% 0/127 • Overall study period (about 4 weeks) If pre-existing signs and symptoms of otomycosis worsen during the study, this was considered a treatment failure instead of an adverse event. The adverse events were reviewed in the safety population which included subjects who received at least 1 dose of study medication (subjects could have positive or negative fungal culture at baseline because the results of baseline culture were not available until a few days after starting the study treatment).	4.7% 3/64 • Number of events 3 • Overall study period (about 4 weeks) If pre-existing signs and symptoms of otomycosis worsen during the study, this was considered a treatment failure instead of an adverse event. The adverse events were reviewed in the safety population which included subjects who received at least 1 dose of study medication (subjects could have positive or negative fungal culture at baseline because the results of baseline culture were not available until a few days after starting the study treatment).

Additional Information

Medical Director

Laboratorios Salvat, S.A

Phone: +34933946400

Email: ejimenez@svt.com

Results disclosure agreements

• Principal investigator is a sponsor employee Any publication shall be expressly authorized in written by the Sponsor.
• Publication restrictions are in place

Restriction type: OTHER