Topical or oral antibiotics in childhood acute otitis media and ear discharge: a randomised controlled non-inferiority trial
Topical or oral antibiotics in childhood acute otitis media and ear discharge: a randomised controlled non-inferiority trial
Background: current guidance suggests oral antibiotics can be considered for children with acute otitis media (AOM) and ear discharge, but there is an absence of evidence regarding the relative effectiveness of antibiotic-corticosteroid eardrops.
Aim: to establish whether antibiotic-corticosteroid eardrops are non-inferior to oral antibiotics in children with AOM and ear discharge.
Design and setting: open randomised controlled non-inferiority trial set in Dutch primary care.
Methods: children were randomised to hydrocortisone-bacitracin-colistin eardrops (five drops, three times per day in the discharging ear(s)) or amoxicillin suspension (50 mg per kilogram of body weight per day, divided over three doses administered orally) for 7 days. Primary outcome was proportion of children with resolution of ear pain and fever at day 3.
Results: between December 2017 and March 2023, 58 of a planned 350 children were recruited due to slow accrual for various reasons. Children assigned to eardrops (n=26) had lower resolution rates of ear pain and fever at 3 days compared to those receiving oral antibiotics (n=31): 42% vs 65%; adjusted risk difference 20.3%, 95% confidence interval -5.3% to 41.9%), longer parent-reported ear discharge (6 vs 3 days; p =0.04), and slightly higher mean ear pain scores (Likert scale 0-6) over days 1-3 (2.1 vs 1.4, p=0.02), but received fewer oral antibiotic courses in three months (11 for 25 children vs 33 for 30 children), and had less GI upset and rash (12% vs 32% and 8% vs 16%, respectively).
Conclusion: early termination stopped us from determining non-inferiority of antibiotic-corticosteroid eardrops. Our limited data, requiring confirmation, suggest that oral antibiotics may be more effective than antibiotic-corticosteroid eardrops in resolving symptoms and shortening the duration of ear discharge.
primary care, Oral Antibiotics, acute otitis media, ear discharge, antibiotic-corticosteroid eardrops, treatment
Hullegie, Saskia
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Damoiseaux, Roger A.M.J.
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Hay, Alastair D.
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Zuithoff, Nicolaas P.A.
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van Dongen, Thijs M.A.
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Little, Paul
1bf2d1f7-200c-47a5-ab16-fe5a8756a777
Schilder, Anne G.M.
4efe172e-cbc9-4d1b-b089-f293f5c626ef
Venekamp, Roderick P.
04309a42-770e-425b-9bc3-85930ca3bcc2
Hullegie, Saskia
41b81796-d69d-42e3-9ee1-c190ff20af63
Damoiseaux, Roger A.M.J.
7e2618ca-ba96-4831-8f9e-444f9e1243c3
Hay, Alastair D.
bfae9e44-ae9b-473c-923f-1dea50747023
Zuithoff, Nicolaas P.A.
1b152e26-e7c7-4b88-b231-26c410726393
van Dongen, Thijs M.A.
8165c8ba-9f39-40d5-991b-6153aaf921a9
Little, Paul
1bf2d1f7-200c-47a5-ab16-fe5a8756a777
Schilder, Anne G.M.
4efe172e-cbc9-4d1b-b089-f293f5c626ef
Venekamp, Roderick P.
04309a42-770e-425b-9bc3-85930ca3bcc2
Hullegie, Saskia, Damoiseaux, Roger A.M.J., Hay, Alastair D., Zuithoff, Nicolaas P.A., van Dongen, Thijs M.A., Little, Paul, Schilder, Anne G.M. and Venekamp, Roderick P.
(2024)
Topical or oral antibiotics in childhood acute otitis media and ear discharge: a randomised controlled non-inferiority trial.
Family Practice.
(In Press)
Abstract
Background: current guidance suggests oral antibiotics can be considered for children with acute otitis media (AOM) and ear discharge, but there is an absence of evidence regarding the relative effectiveness of antibiotic-corticosteroid eardrops.
Aim: to establish whether antibiotic-corticosteroid eardrops are non-inferior to oral antibiotics in children with AOM and ear discharge.
Design and setting: open randomised controlled non-inferiority trial set in Dutch primary care.
Methods: children were randomised to hydrocortisone-bacitracin-colistin eardrops (five drops, three times per day in the discharging ear(s)) or amoxicillin suspension (50 mg per kilogram of body weight per day, divided over three doses administered orally) for 7 days. Primary outcome was proportion of children with resolution of ear pain and fever at day 3.
Results: between December 2017 and March 2023, 58 of a planned 350 children were recruited due to slow accrual for various reasons. Children assigned to eardrops (n=26) had lower resolution rates of ear pain and fever at 3 days compared to those receiving oral antibiotics (n=31): 42% vs 65%; adjusted risk difference 20.3%, 95% confidence interval -5.3% to 41.9%), longer parent-reported ear discharge (6 vs 3 days; p =0.04), and slightly higher mean ear pain scores (Likert scale 0-6) over days 1-3 (2.1 vs 1.4, p=0.02), but received fewer oral antibiotic courses in three months (11 for 25 children vs 33 for 30 children), and had less GI upset and rash (12% vs 32% and 8% vs 16%, respectively).
Conclusion: early termination stopped us from determining non-inferiority of antibiotic-corticosteroid eardrops. Our limited data, requiring confirmation, suggest that oral antibiotics may be more effective than antibiotic-corticosteroid eardrops in resolving symptoms and shortening the duration of ear discharge.
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FAMPR-024-24.R2_manuscript_clean-1
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Accepted/In Press date: 7 June 2024
Keywords:
primary care, Oral Antibiotics, acute otitis media, ear discharge, antibiotic-corticosteroid eardrops, treatment
Identifiers
Local EPrints ID: 491323
URI: http://eprints.soton.ac.uk/id/eprint/491323
ISSN: 0263-2136
PURE UUID: 4865616e-842b-48ae-baba-e001e9687ebf
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Date deposited: 19 Jun 2024 17:02
Last modified: 04 Jul 2024 01:35
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Contributors
Author:
Saskia Hullegie
Author:
Roger A.M.J. Damoiseaux
Author:
Alastair D. Hay
Author:
Nicolaas P.A. Zuithoff
Author:
Thijs M.A. van Dongen
Author:
Anne G.M. Schilder
Author:
Roderick P. Venekamp
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