Evaluation of the Non-Inferiority of Topical Chloramphenicol Versus Topical Ciprofloxacin in the Resolution of Otorrhea in Adults With Chronic Suppurative Otitis Media (CSOM) – Protocol OMCOS

Condition studied

chronic suppurative otitis media (CSOM)

Investigational medicinal product(s)

Eligibility

Primary endpoint

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.

Endpoint detail

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.