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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Institut De Recerca Biomedica De Lleida Fundacio Dr. Pifarre

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Otorhinolaryngologic Diseases [C09]

Decision date (initial)

2026-06-11

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Safety, Efficacy

To evaluate if topical chloramphenicol is non-inferior to topical ciprofloxacin in the resolution of otorrhoea in adult patients with CSOM.

Secondary objectives 5

1. Hearing Improvement: To compare the reduction of hearing loss between both treatment groups by measuring changes in auditory thresholds (dB) via pure-tone audiometry.
2. Safety and Tolerability: To evaluate the incidence of local or systemic adverse reactions associated with the use of topical chloramphenicol and ciprofloxacin.
3. Treatment Adherence: To assess patient adherence to the topical treatment through vial return count and patient self-reporting.
4. Patient-Reported Outcomes (PROs): To evaluate patient perception, quality of life, and treatment satisfaction using a validated questionnaire (Annex 3).
5. Subgroup Analysis (Gender): To analyze potential differences in efficacy and safety between male and female participants.

Conditions and MedDRA coding

chronic suppurative otitis media (CSOM)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Patients aged 18 years or older.
2. Confirmed diagnosis of Chronic Suppurative Otitis Media (CSOM).
3. Ability to follow the protocol instructions and attend all scheduled visits
4. Signed written informed consent prior to any study procedures.

Exclusion criteria 11

1. Having received antibiotic treatment (either topical or systemic) within the month prior to inclusion in the study.
2. Known allergy, hypersensitivity, or intolerance to chloramphenicol, ciprofloxacin, or any of the excipients present in the formulations: Povidone K30, Boric Acid, Sodium Borate, Sodium Chloride, or parabens-group preservatives (present in the commercial solution of ciprofloxacin).
3. Moderate or severe hepatic impairment, due to the potential risk of hepatotoxicity
4. Severe chronic renal failure (eGFR < 20mL /min/1.73 m^2).
5. Women of childbearing potential with a negative pregnancy test at Visit 1 who do not agree to use effective contraceptive methods during the study.
6. Clinical diagnosis of otomycosis.
7. Hematological or bone marrow disorders: historical background or active statuts.
8. Recent use (within the last 7 days) or anticipated need during the study of any topical otic medication other than the one assigned in the protocol, including non-studied topical antibiotics, otic antifungals, and topical corticosteroids.
9. Need for systemic antibiotic, antifungal, or immunosuppressive treatment (including oral corticosteroids) during the study period, which could interfere with the evaluation of the topical therapy.
10. Participation in another clinical trial within 30 days prior to inclusion.
11. Any clinical condition, social circumstances, or concomitant medication that, in the investigator's judgment, compromises protocol compliance or participant safety.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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 endpoints 5

1. Change in auditory thresholds (measured in dB) from baseline (Day 1) to Day 14, assessed via pure-tone audiometry.
2. Incidence, type, and severity of local or systemic adverse events (e.g., local irritation, pruritus, otalgia) reported throughout the study period.
3. 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.
4. Patient-reported quality of life and therapeutic satisfaction scores at Day 14, measured using a validated CSOM-specific questionnaire.
5. Comparative efficacy and safety outcomes at Day 14 and final analysis, stratified by patient gender.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Institut De Recerca Biomedica De Lleida Fundacio Dr. Pifarre

Sponsor organisation

Institut De Recerca Biomedica De Lleida Fundacio Dr. Pifarre

Address

Avinguda De L'Alcalde Rovira Roure 80

City

Lleida

Postcode

25196

Country

Spain

Scientific contact point

Organisation

Institut De Recerca Biomedica De Lleida Fundacio Dr. Pifarre

Contact name

José Maria Sala-Vivé Gallego

Public contact point

Organisation

Institut De Recerca Biomedica De Lleida Fundacio Dr. Pifarre

Contact name

José Maria Sala-Vivé Gallego

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications