Trial Outcomes & Findings for SVT-15652 Otic Solution for the Treatment of Otomycosis (NCT NCT03686384)

NCT ID: NCT03686384

Last Updated: 2024-12-03

Results Overview

Number and percentage of subjects with therapeutic cure

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 217 participants
• Primary outcome timeframe: Test of cure on day 24
• Results posted on: 2024-12-03

Participant Flow

The principal investigator was an otolaryngologist

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).

Participant milestones

Measure	SVT-15652 Investigational treatment 1 vial twice daily	Placebo Comparator 1 vial twice daily
Overall Study STARTED	82	36
Overall Study COMPLETED	75	21
Overall Study NOT COMPLETED	7	15

Reasons for withdrawal

Measure	SVT-15652 Investigational treatment 1 vial twice daily	Placebo Comparator 1 vial twice daily
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

SVT-15652 Otic Solution for the Treatment of Otomycosis

Baseline characteristics by cohort

Measure	SVT-15652 n=82 Participants Investigational treatment 1 vial twice daily	Placebo n=36 Participants Comparator 1 vial twice daily	Total n=118 Participants Total of all reporting groups
Age, Continuous	53.0 years STANDARD_DEVIATION 17.53 • n=5 Participants	53.4 years STANDARD_DEVIATION 19.91 • n=7 Participants	53.1 years STANDARD_DEVIATION 18.20 • n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants	15 Participants n=7 Participants	55 Participants n=5 Participants
Sex: Female, Male Male	42 Participants n=5 Participants	21 Participants n=7 Participants	63 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants	4 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) White	63 Participants n=5 Participants	26 Participants n=7 Participants	89 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment United States	76 participants n=5 Participants	32 participants n=7 Participants	108 participants n=5 Participants
Region of Enrollment Mexico	6 participants n=5 Participants	4 participants n=7 Participants	10 participants n=5 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

Number and percentage of subjects with therapeutic cure

Outcome measures

Measure	SVT-15652 n=82 Participants Investigational treatment 1 vial twice daily	Placebo n=36 Participants Comparator 1 vial twice daily
Therapeutical Cure (Clinical and Mycological Cure)	48 Participants	10 Participants

Adverse Events

SVT-15652

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	SVT-15652 n=134 participants at risk Investigational treatment 1 vial twice daily	Placebo n=68 participants at risk Comparator 1 vial twice daily
Ear and labyrinth disorders Ear pain	1.5% 2/134 • Number of events 2 • Overall study (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).	2.9% 2/68 • Number of events 2 • Overall study (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).
Nervous system disorders Headache	2.2% 3/134 • Number of events 3 • Overall study (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).	2.9% 2/68 • Number of events 2 • Overall study (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