Otitis Media Clinical Trial
Official title:
N-Acetylcysteine as an Adjunct for Refractory Chronic Suppurative Otitis Media
Verified date | November 2019 |
Source | St. Paul's Hospital, Canada |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | November 29, 2019 |
Est. primary completion date | November 29, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | St. Paul's Hospital BC Rotary Hearing & Balance Centre | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
St. Paul's Hospital, Canada |
Canada,
Aslam S, Trautner BW, Ramanathan V, Darouiche RO. Combination of tigecycline and N-acetylcysteine reduces biofilm-embedded bacteria on vascular catheters. Antimicrob Agents Chemother. 2007 Apr;51(4):1556-8. Epub 2007 Jan 12. — View Citation
Choe WT, Murray MT, Stidham KR, Roberson JB. N-Acetylcysteine as an adjunct for refractory ear infections. Otol Neurotol. 2007 Dec;28(8):1022-5. — View Citation
Fergie N, Bayston R, Pearson JP, Birchall JP. Is otitis media with effusion a biofilm infection? Clin Otolaryngol Allied Sci. 2004 Feb;29(1):38-46. Review. — View Citation
Marchese A, Bozzolasco M, Gualco L, Debbia EA, Schito GC, Schito AM. Effect of fosfomycin alone and in combination with N-acetylcysteine on E. coli biofilms. Int J Antimicrob Agents. 2003 Oct;22 Suppl 2:95-100. — View Citation
Ovesen T, Felding JU, Tommerup B, Schousboe LP, Petersen CG. Effect of N-acetylcysteine on the incidence of recurrence of otitis media with effusion and re-insertion of ventilation tubes. Acta Otolaryngol Suppl. 2000;543:79-81. — View Citation
Pérez-Giraldo C, Rodríguez-Benito A, Morán FJ, Hurtado C, Blanco MT, Gómez-García AC. Influence of N-acetylcysteine on the formation of biofilm by Staphylococcus epidermidis. J Antimicrob Chemother. 1997 May;39(5):643-6. — View Citation
Wall GM, Stroman DW, Roland PS, Dohar J. Ciprofloxacin 0.3%/dexamethasone 0.1% sterile otic suspension for the topical treatment of ear infections: a review of the literature. Pediatr Infect Dis J. 2009 Feb;28(2):141-4. doi: 10.1097/INF.0b013e31818b0c9c. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | cessation of otorrhea | 4 weeks | ||
Secondary | durable cessation of otorrhea | 18 months |
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