Povidone-iodine ear wash and oral cotrimoxazole for chronic suppurative otitis media in Australian aboriginal children

Study protocol for factorial design randomised controlled trial

Christine Wigger, Amanda Jane Leach, Jemima Beissbarth, Victor Oguoma, Ruth Lennox, Sandra Nelson, Hemi Patel, Mark Chatfield, Kathy Currie, Harvey Coates, Keith Edwards, Heidi Smith-Vaughan, Kim Hare, Paul Torzillo, Steven Tong, Peter Morris

    Research output: Contribution to journalArticleResearchpeer-review

    Abstract

    Background: Chronic suppurative otitis media (CSOM) is a significant health issue affecting Aboriginal Australians. Long-term hearing loss can cause communication problems, educational disadvantage, and social isolation. Current standard treatment for CSOM in our region is twice daily dry mopping of the pus from the ear canal followed by instillation of ciprofloxacin antibiotic ear drops for up to 16 weeks, or until the discharge resolves for a period of 3 days. The treatment is long, laborious and fails to resolve ear discharge in 70% of cases in remote communities. Bacterial pathogens also persist. Povidone-iodine ear wash is the preferred method of clearing ear discharge in Western Australia. However, evidence of its effectiveness is lacking. In systematic reviews, topical antibiotics (ciprofloxacin) have been shown to be more effective than oral antibiotics or topical antiseptics. Currently, it is unclear whether there are any benefits of combining these treatments. 

    Methods: This protocol describes a 2 × 2 factorial randomised controlled trial of two different interventions (povidone-iodine ear wash and oral cotrimoxazole), given as adjunctive therapy to standard treatment for CSOM. 280 children, between 2 months and 17 years of age, Indigenous or non-Indigenous, living in participating Northern Territory (NT) communities are randomised to standard treatment (dry mopping and ciprofloxacin drops) plus one of two topical treatments (dilute povidone-iodine ear wash or no wash) and one of two oral medication treatments (16 weeks of cotrimoxazole or placebo). 

    Discussion: Current treatment of CSOM in our region shows that eradication of bacterial pathogens from the middle ear space and dry ears is often not achieved. This trial will evaluate the efficacy of adjunctive treatments of antiseptic ear washes and oral antibiotics. Clinical, microbiological and hearing outcomes will be reported. 

    Original languageEnglish
    Article number46
    Pages (from-to)1-6
    Number of pages6
    JournalBMC Pharmacology and Toxicology
    Volume20
    DOIs
    Publication statusPublished - 27 Jul 2019

    Fingerprint

    Suppurative Otitis Media
    Povidone-Iodine
    Sulfamethoxazole Drug Combination Trimethoprim
    Ear
    Randomized Controlled Trials
    Ciprofloxacin
    Anti-Bacterial Agents
    Local Anti-Infective Agents
    Therapeutics
    Northern Territory
    Social Isolation
    Western Australia
    Ear Canal
    Suppuration
    Middle Ear
    Hearing Loss
    Hearing
    Communication
    Placebos

    Cite this

    Wigger, Christine ; Leach, Amanda Jane ; Beissbarth, Jemima ; Oguoma, Victor ; Lennox, Ruth ; Nelson, Sandra ; Patel, Hemi ; Chatfield, Mark ; Currie, Kathy ; Coates, Harvey ; Edwards, Keith ; Smith-Vaughan, Heidi ; Hare, Kim ; Torzillo, Paul ; Tong, Steven ; Morris, Peter. / Povidone-iodine ear wash and oral cotrimoxazole for chronic suppurative otitis media in Australian aboriginal children : Study protocol for factorial design randomised controlled trial. In: BMC Pharmacology and Toxicology. 2019 ; Vol. 20. pp. 1-6.
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    abstract = "Background: Chronic suppurative otitis media (CSOM) is a significant health issue affecting Aboriginal Australians. Long-term hearing loss can cause communication problems, educational disadvantage, and social isolation. Current standard treatment for CSOM in our region is twice daily dry mopping of the pus from the ear canal followed by instillation of ciprofloxacin antibiotic ear drops for up to 16 weeks, or until the discharge resolves for a period of 3 days. The treatment is long, laborious and fails to resolve ear discharge in 70{\%} of cases in remote communities. Bacterial pathogens also persist. Povidone-iodine ear wash is the preferred method of clearing ear discharge in Western Australia. However, evidence of its effectiveness is lacking. In systematic reviews, topical antibiotics (ciprofloxacin) have been shown to be more effective than oral antibiotics or topical antiseptics. Currently, it is unclear whether there are any benefits of combining these treatments. Methods: This protocol describes a 2 × 2 factorial randomised controlled trial of two different interventions (povidone-iodine ear wash and oral cotrimoxazole), given as adjunctive therapy to standard treatment for CSOM. 280 children, between 2 months and 17 years of age, Indigenous or non-Indigenous, living in participating Northern Territory (NT) communities are randomised to standard treatment (dry mopping and ciprofloxacin drops) plus one of two topical treatments (dilute povidone-iodine ear wash or no wash) and one of two oral medication treatments (16 weeks of cotrimoxazole or placebo). Discussion: Current treatment of CSOM in our region shows that eradication of bacterial pathogens from the middle ear space and dry ears is often not achieved. This trial will evaluate the efficacy of adjunctive treatments of antiseptic ear washes and oral antibiotics. Clinical, microbiological and hearing outcomes will be reported. ",
    keywords = "Aboriginal, Children, Chronic suppurative otitis media, Ciprofloxacin, Cotrimoxazole, Indigenous, Povidone-iodine, Randomised controlled trial",
    author = "Christine Wigger and Leach, {Amanda Jane} and Jemima Beissbarth and Victor Oguoma and Ruth Lennox and Sandra Nelson and Hemi Patel and Mark Chatfield and Kathy Currie and Harvey Coates and Keith Edwards and Heidi Smith-Vaughan and Kim Hare and Paul Torzillo and Steven Tong and Peter Morris",
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    Povidone-iodine ear wash and oral cotrimoxazole for chronic suppurative otitis media in Australian aboriginal children : Study protocol for factorial design randomised controlled trial. / Wigger, Christine; Leach, Amanda Jane; Beissbarth, Jemima; Oguoma, Victor; Lennox, Ruth; Nelson, Sandra; Patel, Hemi; Chatfield, Mark; Currie, Kathy; Coates, Harvey; Edwards, Keith; Smith-Vaughan, Heidi; Hare, Kim; Torzillo, Paul; Tong, Steven; Morris, Peter.

    In: BMC Pharmacology and Toxicology, Vol. 20, 46, 27.07.2019, p. 1-6.

    Research output: Contribution to journalArticleResearchpeer-review

    TY - JOUR

    T1 - Povidone-iodine ear wash and oral cotrimoxazole for chronic suppurative otitis media in Australian aboriginal children

    T2 - Study protocol for factorial design randomised controlled trial

    AU - Wigger, Christine

    AU - Leach, Amanda Jane

    AU - Beissbarth, Jemima

    AU - Oguoma, Victor

    AU - Lennox, Ruth

    AU - Nelson, Sandra

    AU - Patel, Hemi

    AU - Chatfield, Mark

    AU - Currie, Kathy

    AU - Coates, Harvey

    AU - Edwards, Keith

    AU - Smith-Vaughan, Heidi

    AU - Hare, Kim

    AU - Torzillo, Paul

    AU - Tong, Steven

    AU - Morris, Peter

    PY - 2019/7/27

    Y1 - 2019/7/27

    N2 - Background: Chronic suppurative otitis media (CSOM) is a significant health issue affecting Aboriginal Australians. Long-term hearing loss can cause communication problems, educational disadvantage, and social isolation. Current standard treatment for CSOM in our region is twice daily dry mopping of the pus from the ear canal followed by instillation of ciprofloxacin antibiotic ear drops for up to 16 weeks, or until the discharge resolves for a period of 3 days. The treatment is long, laborious and fails to resolve ear discharge in 70% of cases in remote communities. Bacterial pathogens also persist. Povidone-iodine ear wash is the preferred method of clearing ear discharge in Western Australia. However, evidence of its effectiveness is lacking. In systematic reviews, topical antibiotics (ciprofloxacin) have been shown to be more effective than oral antibiotics or topical antiseptics. Currently, it is unclear whether there are any benefits of combining these treatments. Methods: This protocol describes a 2 × 2 factorial randomised controlled trial of two different interventions (povidone-iodine ear wash and oral cotrimoxazole), given as adjunctive therapy to standard treatment for CSOM. 280 children, between 2 months and 17 years of age, Indigenous or non-Indigenous, living in participating Northern Territory (NT) communities are randomised to standard treatment (dry mopping and ciprofloxacin drops) plus one of two topical treatments (dilute povidone-iodine ear wash or no wash) and one of two oral medication treatments (16 weeks of cotrimoxazole or placebo). Discussion: Current treatment of CSOM in our region shows that eradication of bacterial pathogens from the middle ear space and dry ears is often not achieved. This trial will evaluate the efficacy of adjunctive treatments of antiseptic ear washes and oral antibiotics. Clinical, microbiological and hearing outcomes will be reported. 

    AB - Background: Chronic suppurative otitis media (CSOM) is a significant health issue affecting Aboriginal Australians. Long-term hearing loss can cause communication problems, educational disadvantage, and social isolation. Current standard treatment for CSOM in our region is twice daily dry mopping of the pus from the ear canal followed by instillation of ciprofloxacin antibiotic ear drops for up to 16 weeks, or until the discharge resolves for a period of 3 days. The treatment is long, laborious and fails to resolve ear discharge in 70% of cases in remote communities. Bacterial pathogens also persist. Povidone-iodine ear wash is the preferred method of clearing ear discharge in Western Australia. However, evidence of its effectiveness is lacking. In systematic reviews, topical antibiotics (ciprofloxacin) have been shown to be more effective than oral antibiotics or topical antiseptics. Currently, it is unclear whether there are any benefits of combining these treatments. Methods: This protocol describes a 2 × 2 factorial randomised controlled trial of two different interventions (povidone-iodine ear wash and oral cotrimoxazole), given as adjunctive therapy to standard treatment for CSOM. 280 children, between 2 months and 17 years of age, Indigenous or non-Indigenous, living in participating Northern Territory (NT) communities are randomised to standard treatment (dry mopping and ciprofloxacin drops) plus one of two topical treatments (dilute povidone-iodine ear wash or no wash) and one of two oral medication treatments (16 weeks of cotrimoxazole or placebo). Discussion: Current treatment of CSOM in our region shows that eradication of bacterial pathogens from the middle ear space and dry ears is often not achieved. This trial will evaluate the efficacy of adjunctive treatments of antiseptic ear washes and oral antibiotics. Clinical, microbiological and hearing outcomes will be reported. 

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    KW - Chronic suppurative otitis media

    KW - Ciprofloxacin

    KW - Cotrimoxazole

    KW - Indigenous

    KW - Povidone-iodine

    KW - Randomised controlled trial

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    U2 - 10.1186/s40360-019-0322-x

    DO - 10.1186/s40360-019-0322-x

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    JO - BMC Pharmacology and Toxicology

    JF - BMC Pharmacology and Toxicology

    SN - 2050-6511

    M1 - 46

    ER -