Topical or oral antibiotics for children with acute otitis media presenting with ear discharge: Study protocol of a randomised controlled non-inferiority trial
Topical or oral antibiotics for children with acute otitis media presenting with ear discharge: Study protocol of a randomised controlled non-inferiority trial
Background Around 15%-20% of children with acute otitis media present with ear discharge due to a spontaneous tear or perforation of the eardrum (AOMd). Current guidance recommends clinicians to consider oral antibiotics as first-line treatment in this condition. The opening in the eardrum however should allow topical antibiotics to enter the middle ear directly. Local administration of antibiotics does not expose children to systemic side effects and may put less selective resistance pressure on bacteria. Evidence on the effectiveness of this approach in children with AOMd is lacking. Methods and analysis A primary care-based, open, individually randomised, controlled, non-inferiority trial. The trial aims to recruit 350 children aged 6 months to 12 years with AOMd and ear pain and/or fever. Participants will be randomised to 7 days of hydrocortisone-bacitracin-colistin eardrops five drops three times daily or amoxicillin oral suspension 50 mg/kg body weight per day, divided over three doses. Parents will keep a daily diary of AOM symptoms, adverse events and complications for 2 weeks. In addition, they will record AOM recurrences, healthcare utilisation and societal costs for 3 months. The primary outcome is the proportion of children without ear pain and fever at day 3. Secondary outcomes include ear pain and fever intensity/severity; days with ear discharge; eardrum perforation at 2 weeks; adverse events during first 2 weeks; costs; and cost effectiveness at 2 weeks and 3 months. The primary analyses will be intention-to-treat and per-protocol analyses will be conducted as well. Ethics and dissemination The medical research ethics committee Utrecht, The Netherlands has given ethical approval (17-400/G-M). Parents/guardians of participants will provide written informed consent. Study results will be submitted for publication in peer-reviewed medical journals and presented at relevant (inter)national scientific meetings. Trial registration number The Netherlands National Trial Register; NTR6723. Date of registration: 27 November 2017.
Acute otitis media, Antibiotic-corticosteroid eardrops, Antimicrobial resistance, Ear discharge, Oral antibiotics
Hullegie, Saskia
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Venekamp, Roderick P.
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Van Dongen, Thijs M.A.
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Mulder, Sanne
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Van Schaik, Willem
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De Wit, G. Ardine
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Hay, Alastair D.
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Little, Paul
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Moore, Michael V.
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Sanders, Elisabeth A.M.
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Bonten, Marc J.M.
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Bogaert, Debby
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Schilder, Anne G.M.
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Damoiseaux, Roger A.M.J.
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16 December 2021
Hullegie, Saskia
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Venekamp, Roderick P.
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Van Dongen, Thijs M.A.
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Mulder, Sanne
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Van Schaik, Willem
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De Wit, G. Ardine
fd9e8229-1cec-4156-b26a-8117111089de
Hay, Alastair D.
981450c6-76fc-44ea-b4b8-1063059d2e80
Little, Paul
1bf2d1f7-200c-47a5-ab16-fe5a8756a777
Moore, Michael V.
1be81dad-7120-45f0-bbed-f3b0cc0cfe99
Sanders, Elisabeth A.M.
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Bonten, Marc J.M.
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Bogaert, Debby
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Schilder, Anne G.M.
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Damoiseaux, Roger A.M.J.
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Hullegie, Saskia, Venekamp, Roderick P., Van Dongen, Thijs M.A., Mulder, Sanne, Van Schaik, Willem, De Wit, G. Ardine, Hay, Alastair D., Little, Paul, Moore, Michael V., Sanders, Elisabeth A.M., Bonten, Marc J.M., Bogaert, Debby, Schilder, Anne G.M. and Damoiseaux, Roger A.M.J.
(2021)
Topical or oral antibiotics for children with acute otitis media presenting with ear discharge: Study protocol of a randomised controlled non-inferiority trial.
BMJ Open, 11 (12), [e052128].
(doi:10.1136/bmjopen-2021-052128).
Abstract
Background Around 15%-20% of children with acute otitis media present with ear discharge due to a spontaneous tear or perforation of the eardrum (AOMd). Current guidance recommends clinicians to consider oral antibiotics as first-line treatment in this condition. The opening in the eardrum however should allow topical antibiotics to enter the middle ear directly. Local administration of antibiotics does not expose children to systemic side effects and may put less selective resistance pressure on bacteria. Evidence on the effectiveness of this approach in children with AOMd is lacking. Methods and analysis A primary care-based, open, individually randomised, controlled, non-inferiority trial. The trial aims to recruit 350 children aged 6 months to 12 years with AOMd and ear pain and/or fever. Participants will be randomised to 7 days of hydrocortisone-bacitracin-colistin eardrops five drops three times daily or amoxicillin oral suspension 50 mg/kg body weight per day, divided over three doses. Parents will keep a daily diary of AOM symptoms, adverse events and complications for 2 weeks. In addition, they will record AOM recurrences, healthcare utilisation and societal costs for 3 months. The primary outcome is the proportion of children without ear pain and fever at day 3. Secondary outcomes include ear pain and fever intensity/severity; days with ear discharge; eardrum perforation at 2 weeks; adverse events during first 2 weeks; costs; and cost effectiveness at 2 weeks and 3 months. The primary analyses will be intention-to-treat and per-protocol analyses will be conducted as well. Ethics and dissemination The medical research ethics committee Utrecht, The Netherlands has given ethical approval (17-400/G-M). Parents/guardians of participants will provide written informed consent. Study results will be submitted for publication in peer-reviewed medical journals and presented at relevant (inter)national scientific meetings. Trial registration number The Netherlands National Trial Register; NTR6723. Date of registration: 27 November 2017.
Text
e052128.full
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More information
Accepted/In Press date: 26 November 2021
Published date: 16 December 2021
Additional Information:
Funding Information:
Funding The trial is supported by a grant from the Netherlands Organisation for Health Research and Development (ZonMw) – Rational Pharmacotherapy 5th Open Call – grant number 84801 5006.
Publisher Copyright:
© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Copyright:
Copyright 2022 Elsevier B.V., All rights reserved.
Keywords:
Acute otitis media, Antibiotic-corticosteroid eardrops, Antimicrobial resistance, Ear discharge, Oral antibiotics
Identifiers
Local EPrints ID: 455283
URI: http://eprints.soton.ac.uk/id/eprint/455283
ISSN: 2044-6055
PURE UUID: 60d6f4d8-6e49-4ed4-98ad-601d6bd4ec77
Catalogue record
Date deposited: 16 Mar 2022 17:55
Last modified: 12 Jul 2024 01:42
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Contributors
Author:
Saskia Hullegie
Author:
Roderick P. Venekamp
Author:
Thijs M.A. Van Dongen
Author:
Sanne Mulder
Author:
Willem Van Schaik
Author:
G. Ardine De Wit
Author:
Alastair D. Hay
Author:
Elisabeth A.M. Sanders
Author:
Marc J.M. Bonten
Author:
Debby Bogaert
Author:
Anne G.M. Schilder
Author:
Roger A.M.J. Damoiseaux
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