Topical ciprofloxin versus topical framycetin-gramicidin-dexamethasone in Australian Aboriginal children with recently treated chronic suppurative otitis media

a randomized controlled trial

Amanda Leach, Yvonne Wood, Edna Gadil, Elizabeth Stubbs, Peter Morris

Research output: Contribution to journalArticleResearchpeer-review

Abstract

Background: Chronic suppurative otitis media (CSOM) affects many children in disadvantaged populations. The most appropriate topical antibiotic treatment in children with persistent disease is unclear. METHODS:: Children with CSOM despite standard topical treatment were randomized to 6-8 weeks of topical ciprofloxacin (CIP) versus topical framycetin-gramicidin-dexamethasone (FGD). Otoscopic, audiologic, and microbiologic outcomes were measured using standardized assessments and blinding. Results: Ninety-seven children were randomized. Ear discharge failed to resolve at the end of therapy in 70% children regardless of allocation [risk difference = -2%; (95% CI: -20 to 16)]. Healing of the tympanic membrane occurred in one of 50 children in the CIP group and none of 47 children in the FGD group. Severity of discharge failed to improve in more than 50% children in each group, and mean hearing threshold (38 dB and 35 dB) and proportion of children with greater than 25 dB hearing loss (98% and 88%) were not significantly different between the CIP and FGD groups. Side effects were rare. Conclusions: This study showed a similarly low rate of improvement or cure in children with persistent CSOM for both CIP and FGD topical therapies. Complications and side effects were insufficient to cease therapy or inform prescribing of either therapy.
Original languageEnglish
Pages (from-to)692-698
Number of pages7
JournalPediatric Infectious Disease Journal
Volume27
Issue number8
Publication statusPublished - 2008

Fingerprint

Framycetin
Suppurative Otitis Media
Gramicidin
Dexamethasone
Randomized Controlled Trials
Ciprofloxacin
Therapeutics
Tympanic Membrane
Vulnerable Populations
Hearing Loss
Hearing
Ear

Cite this

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title = "Topical ciprofloxin versus topical framycetin-gramicidin-dexamethasone in Australian Aboriginal children with recently treated chronic suppurative otitis media: a randomized controlled trial",
abstract = "Background: Chronic suppurative otitis media (CSOM) affects many children in disadvantaged populations. The most appropriate topical antibiotic treatment in children with persistent disease is unclear. METHODS:: Children with CSOM despite standard topical treatment were randomized to 6-8 weeks of topical ciprofloxacin (CIP) versus topical framycetin-gramicidin-dexamethasone (FGD). Otoscopic, audiologic, and microbiologic outcomes were measured using standardized assessments and blinding. Results: Ninety-seven children were randomized. Ear discharge failed to resolve at the end of therapy in 70{\%} children regardless of allocation [risk difference = -2{\%}; (95{\%} CI: -20 to 16)]. Healing of the tympanic membrane occurred in one of 50 children in the CIP group and none of 47 children in the FGD group. Severity of discharge failed to improve in more than 50{\%} children in each group, and mean hearing threshold (38 dB and 35 dB) and proportion of children with greater than 25 dB hearing loss (98{\%} and 88{\%}) were not significantly different between the CIP and FGD groups. Side effects were rare. Conclusions: This study showed a similarly low rate of improvement or cure in children with persistent CSOM for both CIP and FGD topical therapies. Complications and side effects were insufficient to cease therapy or inform prescribing of either therapy.",
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author = "Amanda Leach and Yvonne Wood and Edna Gadil and Elizabeth Stubbs and Peter Morris",
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Topical ciprofloxin versus topical framycetin-gramicidin-dexamethasone in Australian Aboriginal children with recently treated chronic suppurative otitis media : a randomized controlled trial. / Leach, Amanda; Wood, Yvonne; Gadil, Edna; Stubbs, Elizabeth; Morris, Peter.

In: Pediatric Infectious Disease Journal, Vol. 27, No. 8, 2008, p. 692-698.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - Topical ciprofloxin versus topical framycetin-gramicidin-dexamethasone in Australian Aboriginal children with recently treated chronic suppurative otitis media

T2 - a randomized controlled trial

AU - Leach, Amanda

AU - Wood, Yvonne

AU - Gadil, Edna

AU - Stubbs, Elizabeth

AU - Morris, Peter

PY - 2008

Y1 - 2008

N2 - Background: Chronic suppurative otitis media (CSOM) affects many children in disadvantaged populations. The most appropriate topical antibiotic treatment in children with persistent disease is unclear. METHODS:: Children with CSOM despite standard topical treatment were randomized to 6-8 weeks of topical ciprofloxacin (CIP) versus topical framycetin-gramicidin-dexamethasone (FGD). Otoscopic, audiologic, and microbiologic outcomes were measured using standardized assessments and blinding. Results: Ninety-seven children were randomized. Ear discharge failed to resolve at the end of therapy in 70% children regardless of allocation [risk difference = -2%; (95% CI: -20 to 16)]. Healing of the tympanic membrane occurred in one of 50 children in the CIP group and none of 47 children in the FGD group. Severity of discharge failed to improve in more than 50% children in each group, and mean hearing threshold (38 dB and 35 dB) and proportion of children with greater than 25 dB hearing loss (98% and 88%) were not significantly different between the CIP and FGD groups. Side effects were rare. Conclusions: This study showed a similarly low rate of improvement or cure in children with persistent CSOM for both CIP and FGD topical therapies. Complications and side effects were insufficient to cease therapy or inform prescribing of either therapy.

AB - Background: Chronic suppurative otitis media (CSOM) affects many children in disadvantaged populations. The most appropriate topical antibiotic treatment in children with persistent disease is unclear. METHODS:: Children with CSOM despite standard topical treatment were randomized to 6-8 weeks of topical ciprofloxacin (CIP) versus topical framycetin-gramicidin-dexamethasone (FGD). Otoscopic, audiologic, and microbiologic outcomes were measured using standardized assessments and blinding. Results: Ninety-seven children were randomized. Ear discharge failed to resolve at the end of therapy in 70% children regardless of allocation [risk difference = -2%; (95% CI: -20 to 16)]. Healing of the tympanic membrane occurred in one of 50 children in the CIP group and none of 47 children in the FGD group. Severity of discharge failed to improve in more than 50% children in each group, and mean hearing threshold (38 dB and 35 dB) and proportion of children with greater than 25 dB hearing loss (98% and 88%) were not significantly different between the CIP and FGD groups. Side effects were rare. Conclusions: This study showed a similarly low rate of improvement or cure in children with persistent CSOM for both CIP and FGD topical therapies. Complications and side effects were insufficient to cease therapy or inform prescribing of either therapy.

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SN - 0891-3668

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