Acute Otitis Media
Conditions
Keywords
with tubes
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 middle ear infections in children with ear tubes.
Interventions
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 12 Years
Healthy volunteers
No
Inclusion criteria
* 6 months to 12 years * ear tube in the ear which will be treated * otorrhea for 3 weeks or less * moderate or severe otorrhea
Exclusion criteria
* other ear diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Cessation of Otorrhea | From baseline until the end of the study (up to 22 days) |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DF289 Ear drops
DF289: Ear drops | 112 |
| DF277 Ear drops
DF277: Ear drops | 108 |
| DF289 Plus DF277 Ear drops
DF289 plus DF277: Ear drops | 111 |
| Total | 331 |
Baseline characteristics
| Characteristic | DF289 | DF277 | DF289 Plus DF277 | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 112 Participants | 108 Participants | 111 Participants | 331 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 3.3 years STANDARD_DEVIATION 2.4 | 3.2 years STANDARD_DEVIATION 2.3 | 3.2 years STANDARD_DEVIATION 2.5 | 3.2 years STANDARD_DEVIATION 2.4 |
| Sex: Female, Male Female | 43 Participants | 49 Participants | 46 Participants | 138 Participants |
| Sex: Female, Male Male | 69 Participants | 59 Participants | 65 Participants | 193 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 20 / 112 | 29 / 107 | 25 / 111 |
| serious Total, serious adverse events | 1 / 112 | 0 / 107 | 1 / 111 |
Outcome results
Primary
Time to Cessation of Otorrhea
Time frame: From baseline until the end of the study (up to 22 days)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| DF289 | Time to Cessation of Otorrhea | 6.83 days |
| DF277 | Time to Cessation of Otorrhea | 22 days |
| DF289 Plus DF277 | Time to Cessation of Otorrhea | 4.94 days |