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

NCT00956748 | Withdrawn Phase 4

• 1 other identifier: H09-00953
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Otitis Media; Otorrhea

Keywords

chronic suppurative otitis media with persistent otorrhea

Outcome Measures

Primary Outcomes (1)

• cessation of otorrhea

  4 weeks

Secondary Outcomes (1)

• durable cessation of otorrhea

  18 months

Study Arms (2)

Ciprodex otic solution

ACTIVE COMPARATOR

ciprofloxacin 0.3% / dexamethasone 0.1% otic solution

Drug: Ciprodex

Ciprodex with 2% NAC

EXPERIMENTAL

Ciprodex otic solution (ciprofloxacin 0.3% / dexamethasone 0.1%) augmented with 2% N-acetylcysteine

Drug: Ciprodex and 2% NAC

Interventions

Ciprodex DRUG

Administer 3 to 5 drops tid for 14 days. Continue treatment for another 14 days if otorrhea persists.

Also known as: ciprofloxacin 0.3% / dexamethasone 0.1%

Ciprodex otic solution

Ciprodex and 2% NAC DRUG

Administer 3 to 5 drops tid for 14 days. Continue treatment for another 14 days if otorrhea persists.

Also known as: Ciprodex with 2% N-Acetylcysteine

Ciprodex with 2% NAC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• existing cholesteatoma
• known allergy to ciprofloxacin, dexamethasone, or N-acetylcysteine
• patients who are unlikely to adhere to the treatment regime and follow-up visits

Sponsors & Collaborators

• St. Paul's Hospital, Canada: lead

Study Sites (1)

St. Paul's Hospital BC Rotary Hearing & Balance Centre

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Related Publications (7)

• 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. doi: 10.1111/j.1365-2273.2004.00767.x.

  PMID: 14961850 BACKGROUND

• 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.

  PMID: 19116600 BACKGROUND

• 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. doi: 10.1097/MAO.0b013e318155a4d3.

  PMID: 17898673 BACKGROUND

• Perez-Giraldo C, Rodriguez-Benito A, Moran FJ, Hurtado C, Blanco MT, Gomez-Garcia AC. Influence of N-acetylcysteine on the formation of biofilm by Staphylococcus epidermidis. J Antimicrob Chemother. 1997 May;39(5):643-6. doi: 10.1093/jac/39.5.643.

  PMID: 9184365 BACKGROUND

• 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. doi: 10.1016/s0924-8579(03)00232-2.

  PMID: 14527779 BACKGROUND

• 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. doi: 10.1128/AAC.00893-06. Epub 2007 Jan 12.

  PMID: 17220399 BACKGROUND

• 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. doi: 10.1080/000164800454044.

  PMID: 10908985 BACKGROUND

MeSH Terms

Conditions

Otitis Media

Interventions

Ciprofloxacin; Acetylcysteine

Condition Hierarchy (Ancestors)

Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Brian D Westerberg, MD

  St. Paul's Hospital Rotary Hearing Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor, Department of Surgery, UBC Otology & Neurotology

Study Record Dates

• First Submitted: August 7, 2009
• First Posted: August 11, 2009
• Study Start: November 29, 2019
• Primary Completion: November 29, 2019
• Study Completion: November 29, 2019
• Last Updated: December 3, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)