WithdrawnPhase 4

N-Acetylcysteine as an Adjunct for Refractory Chronic Suppurative Otitis Media

Stopped: Lack of staff, time, and resources

Canada0Started 2019-11-29

Plain-language summary

Chronic suppurative otitis media (CSOM) can be particularly difficult to treat as a number of patients do not respond to routine antibiotic or surgical treatments. The current treatment involves administering combination antibiotic anti-inflammatory ear drops such as Ciprodex (ciprofloxacin 0.3% / dexamethasone 0.1%). Although most patients experience a relief of symptoms, a fraction of patients remain refractory to treatment. Recent findings suggest that the addition of N-acetylcysteine (0.5-2%) to Ciprodex is a superior treatment for otitis media with effusion compared to the use of Ciprodex alone.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * continuous otorrhea for a duration of greater than 6 months * at least 2 previous treatment regimes for otitis media, which may include topical or oral antibiotics, myringotomy or tympanostomy, and surgery Exclusion Criteria: * existing cholesteatoma * known allergy to ciprofloxacin, dexamethasone, or N-acetylcysteine * patients who are unlikely to adhere to the treatment regime and follow-up visits

What they're measuring

cessation of otorrhea

Timeframe: 4 weeks

Trial details

NCT IDNCT00956748

SponsorSt. Paul's Hospital, Canada

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-11-29

View on ClinicalTrials.gov More Otitis Media trials