chronic suppurative otitis media (CSOM)
Conditions
Brief summary
Proportion of patients with complete resolution of otorrhoea at Day 14, assessed by otoscopy/endoscopy performed by at least two otolaryngologists with digital photographic records.
Detailed description
Change in auditory thresholds (measured in dB) from baseline (Day 1) to Day 14, assessed via pure-tone audiometry., Incidence, type, and severity of local or systemic adverse events (e.g., local irritation, pruritus, otalgia) reported throughout the study period., Treatment adherence rate at Day 14, defined as the proportion of unused medication (vial count) and verified by patient self-reporting in the treatment diary., Patient-reported quality of life and therapeutic satisfaction scores at Day 14, measured using a validated CSOM-specific questionnaire., Comparative efficacy and safety outcomes at Day 14 and final analysis, stratified by patient gender.
Interventions
DRUGCetraxal ótico 3 mg/ml gotas óticas en solución.
DRUGCHLORAMPHENICOL
Sponsors
Institut De Recerca Biomedica De Lleida Fundacio Dr. Pifarre
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with complete resolution of otorrhoea at Day 14, assessed by otoscopy/endoscopy performed by at least two otolaryngologists with digital photographic records. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in auditory thresholds (measured in dB) from baseline (Day 1) to Day 14, assessed via pure-tone audiometry., Incidence, type, and severity of local or systemic adverse events (e.g., local irritation, pruritus, otalgia) reported throughout the study period., Treatment adherence rate at Day 14, defined as the proportion of unused medication (vial count) and verified by patient self-reporting in the treatment diary., Patient-reported quality of life and therapeutic satisfaction scores at Day 14, measured using a validated CSOM-specific questionnaire., Comparative efficacy and safety outcomes at Day 14 and final analysis, stratified by patient gender. | — |
Outcome results
None listed