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

Sponsor:	St. Paul's Hospital, Canada
Information provided by:	St. Paul's Hospital, Canada
ClinicalTrials.gov Identifier:	NCT00956748

Purpose

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.

Condition	Intervention	Phase
Otitis Media Otorrhea	Drug: Ciprodex Drug: Ciprodex and 2% NAC	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	N-Acetylcysteine as an Adjunct for Refractory Chronic Suppurative Otitis Media

Resource links provided by NLM:

MedlinePlus related topics: Ear Infections

Drug Information available for: Dexamethasone Dexamethasone acetate Doxiproct plus Ciprofloxacin Ciprofloxacin hydrochloride Ciprofloxacin lactate Acetylcysteine Dexamethasone Sodium Phosphate

U.S. FDA Resources

Further study details as provided by St. Paul's Hospital, Canada:

Primary Outcome Measures:

cessation of otorrhea [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

durable cessation of otorrhea [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	October 2009
Estimated Study Completion Date:	October 2011
Estimated Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Ciprodex otic solution ciprofloxacin 0.3% / dexamethasone 0.1% otic solution	Drug: Ciprodex Administer 3 to 5 drops tid for 14 days. Continue treatment for another 14 days if otorrhea persists. Other Name: ciprofloxacin 0.3% / dexamethasone 0.1%
Experimental: Ciprodex with 2% NAC Ciprodex otic solution (ciprofloxacin 0.3% / dexamethasone 0.1%) augmented with 2% N-acetylcysteine	Drug: Ciprodex and 2% NAC Administer 3 to 5 drops tid for 14 days. Continue treatment for another 14 days if otorrhea persists. Other Name: Ciprodex with 2% N-Acetylcysteine

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00956748

Contacts

Contact: John Phillips, MD	604-806-8540	john.phillips@mac.com
Contact: Helen Jiang, B.Sc	604-782-3900	heljiang@gmail.com

Locations

Canada, British Columbia
St. Paul's Hospital Rotary Hearing Clinic	Not yet recruiting
Vancouver, British Columbia, Canada, V6Z 1Y6
Principal Investigator: Brian D Westerberg, MD

Sponsors and Collaborators

St. Paul's Hospital, Canada

Investigators

Principal Investigator:

Brian D Westerberg, MD

St. Paul's Hospital Rotary Hearing Clinic

More Information

Publications:

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.

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. Review.

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.

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.

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.

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.

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.

Responsible Party:	Dr. Westerberg, Brian D., St. Paul's Hospital Rotary Hearing Clinic
ClinicalTrials.gov Identifier:	NCT00956748 History of Changes
Other Study ID Numbers:	H09-00953
Study First Received:	August 7, 2009
Last Updated:	August 10, 2009
Health Authority:	Canada: Health Canada

Keywords provided by St. Paul's Hospital, Canada:

chronic suppurative otitis media with persistent otorrhea

Additional relevant MeSH terms:

Otitis
Otitis Media
Otitis Media, Suppurative
Suppuration
Ear Diseases
Otorhinolaryngologic Diseases
Infection
Inflammation
Pathologic Processes
Acetylcysteine
Ciprofloxacin
N-monoacetylcystine
BB 1101
Dexamethasone acetate
Dexamethasone

Dexamethasone 21-phosphate
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012