Acute Otitis Externa
Conditions
Brief summary
The purpose of this study is to determine if a combination of an antibiotic plus a corticosteroid is safe and effective in treating AOE
Interventions
DRUGDF289 plus DF277
1 vial into the affected ear twice daily for 7 days
DRUGDF289
1 vial into the affected ear twice daily for 7 days
DRUGDF277
1 vial into the affected ear twice daily for 7 days
Sponsors
Salvat
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
No
Inclusion criteria
* Uncomplicated AOE of less tan 21 days, defined as a total symptom score of at least 2 for otalgia, 2 for edema and 1 for otorrhea * Brighton Grading of II or III * Culture-based diagnosis of acute bacterial otitis externa * Willingness to refrain from swimming through end of the study
Exclusion criteria
* Previous episode of AOE within 4 weeks prior to enrollment, or 2 or more episodes of AOE within 6 months prior to the enrollment. * Tympanic membrane perforation * Any condition or situation likely to cause the patient to be unable or unwilling to comply with study treatment or attend all study visits * Any condition in the patient or parent/guardian that, in the judgment of the principal investigator, could compromise patient safety, limit the patient's ability to complete the study, and/or compromise the objectives of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Therapeutic Cure (Clinical + Microbiological Cure) | End of Treatment (Day 8+2) | Therapeutic cure will be considered achieved if edema, otalgia and otorrhea are resolved with no further requirement of antimicrobial therapy and bacteriological response is Eradication or Presumed Eradication |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to End of Pain | From baseline to End of Study (Day 15+2) | First day on which there is no use of analgesics, the pain score is zero and remains zero until end of study |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DF289 Plus DF277 Otic solution
DF289 plus DF277: 1 vial into the affected ear twice daily for 7 days | 197 |
| DF289 Otic solution
DF289: 1 vial into the affected ear twice daily for 7 days | 196 |
| DF277 Otic solution
DF277: 1 vial into the affected ear twice daily for 7 days | 100 |
| Total | 493 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Administration of a wrong kit of study medication | 0 | 1 | 0 |
| Overall Study | Adverse Event | 1 | 1 | 2 |
| Overall Study | Consent withdrawn | 2 | 1 | 0 |
| Overall Study | Lack of Efficacy | 2 | 6 | 1 |
| Overall Study | Lost to Follow-up | 4 | 3 | 2 |
Baseline characteristics
| Characteristic | DF289 | DF277 | Total | DF289 Plus DF277 |
|---|---|---|---|---|
| Age, Categorical <=18 years | 57 Participants | 31 Participants | 145 Participants | 57 Participants |
| Age, Categorical >=65 years | 24 Participants | 15 Participants | 77 Participants | 38 Participants |
| Age, Categorical Between 18 and 65 years | 115 Participants | 54 Participants | 271 Participants | 102 Participants |
| Age, Continuous | 38.4 years STANDARD_DEVIATION 22.64 | 38.7 years STANDARD_DEVIATION 22.79 | 38.2 years STANDARD_DEVIATION 23.1 | 37.8 years STANDARD_DEVIATION 23.81 |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 0 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 30 Participants | 15 Participants | 74 Participants | 29 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 7 Participants | 4 Participants |
| Race (NIH/OMB) White | 161 Participants | 82 Participants | 405 Participants | 162 Participants |
| Region of Enrollment United States | 196 participants | 100 participants | 493 participants | 197 participants |
| Sex: Female, Male Female | 101 Participants | 56 Participants | 254 Participants | 97 Participants |
| Sex: Female, Male Male | 95 Participants | 44 Participants | 239 Participants | 100 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 196 | 0 / 195 | 0 / 100 |
| other Total, other adverse events | 11 / 196 | 12 / 195 | 4 / 100 |
| serious Total, serious adverse events | 1 / 196 | 0 / 195 | 0 / 100 |
Outcome results
Primary
Therapeutic Cure (Clinical + Microbiological Cure)
Therapeutic cure will be considered achieved if edema, otalgia and otorrhea are resolved with no further requirement of antimicrobial therapy and bacteriological response is Eradication or Presumed Eradication
Time frame: End of Treatment (Day 8+2)
Population: Randomized patients with positive culture for pathogens at baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DF289 Plus DF277 | Therapeutic Cure (Clinical + Microbiological Cure) | 63 Participants |
| DF289 | Therapeutic Cure (Clinical + Microbiological Cure) | 49 Participants |
| DF277 | Therapeutic Cure (Clinical + Microbiological Cure) | 20 Participants |
Secondary
Time to End of Pain
First day on which there is no use of analgesics, the pain score is zero and remains zero until end of study
Time frame: From baseline to End of Study (Day 15+2)
Population: Randomized patients with positive culture for pathogens at baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| DF289 Plus DF277 | Time to End of Pain | 5.0 days |
| DF289 | Time to End of Pain | 5.9 days |
| DF277 | Time to End of Pain | 7.7 days |