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

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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. ",
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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 - Children

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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JF - BMC Pharmacology and Toxicology

SN - 2050-6511

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