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Non‑Inferiority Study of Topical Chloramphenicol vs Topical Ciprofloxacin for Otorrhea in Adults with Chronic Suppurative Otitis Media

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What is this study about?

The study focuses on adults who have chronic suppurative otitis media, a long‑lasting ear infection that causes persistent discharge (otorrhoea) from the ear. Two topical antibiotics are being compared: chloramphenicol ear drops and ciprofloxacin ear drops. The purpose of the study is to determine whether the former is not worse than the latter in stopping the ear discharge.

Participants will be assigned to receive one of the ear‑drop treatments for about two weeks. During the study they will have an ear examination (otoscopy) performed by specialists, and a hearing assessment using pure-tone audiometry, a test that measures the quietest sounds a person can hear at different pitches. They will also keep a short diary to record any side effects such as irritation or pain, and the amount of medication used. At the end of the 14‑day period the researchers will compare the rate of complete resolution of discharge, changes in hearing ability, and reported side effects between the two groups.

1 enrollment and consent

after joining the study, you sign a consent form that explains the purpose and procedures of the trial.

you receive information about the condition chronic suppurative otitis media (csom) and the two possible ear drop treatments.

2 baseline visit (day 1)

you attend the clinic for the first assessment, which includes an ear examination (otoscopy) performed by specialists and a hearing test (pure‑tone audiometry) to record baseline auditory thresholds.

a questionnaire about quality of life and symptoms is completed.

you are given a vial of the assigned ear drops: either chloramphenicol 2 mg per dose or ciprofloxacin 1.2 mg per dose, both intended for auricular (ear) use.

instructions for how to apply the drops and how to record each use in a diary are provided.

3 home treatment period (days 1–14)

you apply the assigned ear drops to the affected ear according to the schedule written in the diary; the total treatment period lasts 14 days.

each application uses the specified dose (2 mg of chloramphenicol or 1.2 mg of ciprofloxacin).

you record each dose in the treatment diary and note any symptoms such as ear pain, irritation, itching, or discharge.

4 day 14 follow‑up visit

you return to the clinic for a second ear examination to determine whether the otorrhea (ear discharge) has resolved.

the same hearing test is repeated to compare auditory thresholds with the baseline measurement.

the investigator reviews the diary, counts any unused medication, and asks about any local or systemic adverse events (for example, irritation, itching, or ear pain).

you complete the same quality‑of‑life questionnaire to assess any changes.

5 study completion

after the day 14 visit, no further study procedures are required from you.

the collected data are analyzed to compare the effectiveness and safety of the two ear‑drop treatments.

Who Can Join the Study?

  • Be 18 years old or older.
  • Have a confirmed diagnosis of Chronic Suppurative Otitis Media (CSOM), which is a long‑lasting ear infection that causes ear discharge.
  • Be able to understand and follow the study instructions and attend all required study visits.
  • Provide written permission (signed informed consent) after learning about the study.
  • Both men and women are eligible to join.

Who Cannot Join the Study?

  • Having taken any antibiotic (either ear drops or pills) within the month before joining the study.
  • Participating in another clinical trial within the 30 days before enrollment.
  • Having any health problem, personal situation, or taking other medicines that the doctor believes could make it hard to follow the study rules or could be unsafe.
  • Having a known allergy or intolerance to chloramphenicol, ciprofloxacin, or any ingredients such as povidone K30, boric acid, sodium borate, sodium chloride, or parabens.
  • Having moderate or severe liver problems (called hepatic impairment) because the study medicines could harm the liver.
  • Having severe chronic kidney failure with an eGFR less than 20 mL/min/1.73 m²; eGFR is a test that shows how well the kidneys filter blood.
  • Being a woman who could become pregnant and not agreeing to use reliable birth control during the study, even if a pregnancy test is negative at the start.
  • Having a fungal ear infection, known as otomycosis.
  • Having a history of or current blood or bone‑marrow disorder.
  • Using any other ear drops (including other antibiotics, antifungal ear drops, or steroid ear drops) in the last 7 days or planning to use them during the study.
  • Needing oral (systemic) antibiotics, antifungal medicines, or immune‑suppressing drugs (including oral steroids) while in the study.

Where you can join this trial?

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Other Sites

Site Name City Country Status
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida Lleida Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Not yet recruiting
12.10.2026

Trial locations

Investigated drugs:

Ciprofloxacin ear drops are a medication applied directly into the ear. They contain an antibiotic that kills the bacteria that cause ear infections. In this study, the ciprofloxacin drops are used as the standard treatment to compare the new treatment against. The goal is to see if the new medication works at least as well as these established ear drops in stopping ear discharge.

Chloramphenicol ear drops are another type of antibiotic that is placed in the ear. This medication is being tested to find out whether it is as effective as the ciprofloxacin drops for treating ear discharge in adults with chronic ear infection. If it works well, it could become an alternative option for patients.

Chronic suppurative otitis media – It is a long‑lasting infection of the middle ear that produces a persistent discharge from the ear. The condition usually follows repeated or untreated ear infections that damage the eardrum and middle‑ear structures. Over time, the ear may develop a small opening that allows fluid and pus to leak. The discharge can be clear, yellow or bloody and may come and go. The disease can cause gradual changes in hearing as the ear tissue becomes inflamed and scarred. It typically continues unless the underlying infection is cleared.

Trial ID:
2026-525540-15-00
Protocol code:
OMCOS
Trial Phase:
Therapeutic confirmatory (Phase III)

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