SYF8fe5f7ab371c4e3f881a904a7e14e1a5Registry ID: 2026-525540-15-00|Not Yet RecruitingPhase 3
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interventional
N/A
1 country
1
To evaluate if topical chloramphenicol is non-inferior to topical ciprofloxacin in the resolution of otorrhoea in adult patients with CSOM.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
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February 26, 2026
Actual (reported)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.
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.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
Cetraxal ótico 3 mg/ml gotas óticas en solución.
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
EAR DROPS, SOLUTION
View registry recordFormulated product
CHLORAMPHENICOL
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
EAR DROPS, SOLUTION
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
Cetraxal ótico 3 mg/ml gotas óticas en solución.
Named ingredient: Ciprofloxacin
View registry recordCHLORAMPHENICOL
Named ingredient: Chloramphenicol
View registry recordHospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
Lleida, 25196, Spain
José Maria Sala-Vivé Gallego
First Submitted
February 26, 2026
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
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