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
N1 - Funding Information:
This study is funded by the National Health and Medical Research Council, NHMRC grant number: 1060764. The funder had no role in the design or conduct of the study, in any future analysis or interpretation of data; or in the preparation of this manuscript. The study sponsor is the Menzies School of Health Research, located in the Northern Territory, Australia.
Publisher Copyright:
© 2019 The Author(s).
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.TRIAL REGISTRATION: This trial (ACTRN12614000234617) was registered with ANZCTR on 05 April 2014.
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.TRIAL REGISTRATION: This trial (ACTRN12614000234617) was registered with ANZCTR on 05 April 2014.
KW - Aboriginal
KW - Children
KW - Chronic suppurative otitis media
KW - Ciprofloxacin
KW - Cotrimoxazole
KW - Indigenous
KW - Povidone-iodine
KW - Randomised controlled trial
UR - http://www.scopus.com/inward/record.url?scp=85069866856&partnerID=8YFLogxK
U2 - 10.1186/s40360-019-0322-x
DO - 10.1186/s40360-019-0322-x
M3 - Article
C2 - 31351491
SN - 2050-6511
VL - 20
SP - 1
EP - 6
JO - BMC pharmacology & toxicology
JF - BMC pharmacology & toxicology
IS - 1
M1 - 46
ER -