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Povidone-iodine ear wash and oral cotrimoxazole for chronic suppurative otitis media in Australian aboriginal children555.35 kB
Published VersionCC BY V4.0, Open Access
Journal article
Povidone-iodine ear wash and oral cotrimoxazole for chronic suppurative otitis media in Australian aboriginal children: study protocol for factorial design randomised controlled trial
BMC Pharmacology & Toxicology, Vol.20, pp.1-6
2019
PMID: 31351491
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.
Trial registration:
This trial (ACTRN12614000234617) was registered with ANZCTR on 05 April 2014.
Details
- Title
- Povidone-iodine ear wash and oral cotrimoxazole for chronic suppurative otitis media in Australian aboriginal children: study protocol for factorial design randomised controlled trial
- Authors
- Christine Wigger (Corresponding Author) - Menzies School of Health ResearchAmanda Jane Leach - Menzies School of Health ResearchJemima Beissbarth - Menzies School of Health ResearchVictor Oguoma (Author) - Menzies School of Health ResearchRuth Lennox (Author) - Menzies School of Health ResearchSandra Nelson (Author) - Northern Territory Health ServicesHemi Patel (Author) - Royal Darwin HospitalMark D Chatfield (Author) - The University of QueenslandKathy Currie (Author) - Northern Territory Health ServicesHarvey Coates (Author) - The University of Western AustraliaKeith Edwards (Author) - Northern Territory Health ServicesHeidi Smith-Vaughan (Author) - Menzies School of Health ResearchKim Hare (Author) - Menzies School of Health ResearchPaul Torzillo (Author) - Royal Prince Alfred HospitalSteven Y C Tong (Author) - The Royal Melbourne HospitalPeter Morris (Author) - Royal Darwin Hospital
- Publication details
- BMC Pharmacology & Toxicology, Vol.20, pp.1-6
- Publisher
- BioMed Central Ltd.
- Date published
- 2019
- DOI
- 10.1186/s40360-019-0322-x
- ISSN
- 2050-6511
- PMID
- 31351491
- Copyright note
- © The Author(s). This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
- Data Availability
- These is no minimal datasets or material presented in this manuscript that would be necessary to interpret. Data that supports this study protocol can be obtained from the corresponding author, providing appropriate ethical and community approvals are provided. Data are not available on a public repository.
- Organisation Unit
- Thompson Institute
- Language
- English
- Record Identifier
- 991121850502621
- Output Type
- Journal article
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- Pharmacology & Pharmacy
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