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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
EU CTIS ID: 2026-525540-15-00
What this study is testing
To evaluate if topical chloramphenicol is non-inferior to topical ciprofloxacin in the resolution of otorrhoea in adult patients with CSOM.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients aged 18 years or older.
- Confirmed diagnosis of Chronic Suppurative Otitis Media (CSOM).
- Ability to follow the protocol instructions and attend all scheduled visits
- Signed written informed consent prior to any study procedures.
You likely can't join if
- Having received antibiotic treatment (either topical or systemic) within the month prior to inclusion in the study.
- Participation in another clinical trial within 30 days prior to inclusion.
- Any clinical condition, social circumstances, or concomitant medication that, in the investigator's judgment, compromises protocol compliance or participant safety.
- 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).
- Moderate or severe hepatic impairment, due to the potential risk of hepatotoxicity
- Severe chronic renal failure (eGFR < 20mL /min/1.73 m^2).
See the full eligibility criteria
- Patients aged 18 years or older.
- Confirmed diagnosis of Chronic Suppurative Otitis Media (CSOM).
- Ability to follow the protocol instructions and attend all scheduled visits
- Signed written informed consent prior to any study procedures.
- Having received antibiotic treatment (either topical or systemic) within the month prior to inclusion in the study.
- Participation in another clinical trial within 30 days prior to inclusion.
- Any clinical condition, social circumstances, or concomitant medication that, in the investigator's judgment, compromises protocol compliance or participant safety.
- 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).
- Moderate or severe hepatic impairment, due to the potential risk of hepatotoxicity
- Severe chronic renal failure (eGFR < 20mL /min/1.73 m^2).
- Women of childbearing potential with a negative pregnancy test at Visit 1 who do not agree to use effective contraceptive methods during the study.
- Clinical diagnosis of otomycosis.
- Hematological or bone marrow disorders: historical background or active statuts.
- 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.
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.