Cargando…
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...
Autores principales: | , , , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2021
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8679066/ https://www.ncbi.nlm.nih.gov/pubmed/34916313 http://dx.doi.org/10.1136/bmjopen-2021-052128 |
_version_ | 1784616437737848832 |
---|---|
author | 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 GM Damoiseaux, Roger A M J |
author_facet | 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 GM Damoiseaux, Roger A M J |
author_sort | Hullegie, Saskia |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-8679066 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-86790662022-01-04 Topical or oral antibiotics for children with acute otitis media presenting with ear discharge: study protocol of a randomised controlled non-inferiority trial 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 GM Damoiseaux, Roger A M J BMJ Open General practice / Family practice 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. BMJ Publishing Group 2021-12-16 /pmc/articles/PMC8679066/ /pubmed/34916313 http://dx.doi.org/10.1136/bmjopen-2021-052128 Text en © 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. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) . |
spellingShingle | General practice / Family practice 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 GM Damoiseaux, Roger A M J Topical or oral antibiotics for children with acute otitis media presenting with ear discharge: study protocol of a randomised controlled non-inferiority trial |
title | Topical or oral antibiotics for children with acute otitis media presenting with ear discharge: study protocol of a randomised controlled non-inferiority trial |
title_full | Topical or oral antibiotics for children with acute otitis media presenting with ear discharge: study protocol of a randomised controlled non-inferiority trial |
title_fullStr | Topical or oral antibiotics for children with acute otitis media presenting with ear discharge: study protocol of a randomised controlled non-inferiority trial |
title_full_unstemmed | Topical or oral antibiotics for children with acute otitis media presenting with ear discharge: study protocol of a randomised controlled non-inferiority trial |
title_short | Topical or oral antibiotics for children with acute otitis media presenting with ear discharge: study protocol of a randomised controlled non-inferiority trial |
title_sort | topical or oral antibiotics for children with acute otitis media presenting with ear discharge: study protocol of a randomised controlled non-inferiority trial |
topic | General practice / Family practice |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8679066/ https://www.ncbi.nlm.nih.gov/pubmed/34916313 http://dx.doi.org/10.1136/bmjopen-2021-052128 |
work_keys_str_mv | AT hullegiesaskia topicalororalantibioticsforchildrenwithacuteotitismediapresentingwitheardischargestudyprotocolofarandomisedcontrollednoninferioritytrial AT venekamproderickp topicalororalantibioticsforchildrenwithacuteotitismediapresentingwitheardischargestudyprotocolofarandomisedcontrollednoninferioritytrial AT vandongenthijsma topicalororalantibioticsforchildrenwithacuteotitismediapresentingwitheardischargestudyprotocolofarandomisedcontrollednoninferioritytrial AT muldersanne topicalororalantibioticsforchildrenwithacuteotitismediapresentingwitheardischargestudyprotocolofarandomisedcontrollednoninferioritytrial AT vanschaikwillem topicalororalantibioticsforchildrenwithacuteotitismediapresentingwitheardischargestudyprotocolofarandomisedcontrollednoninferioritytrial AT dewitgardine topicalororalantibioticsforchildrenwithacuteotitismediapresentingwitheardischargestudyprotocolofarandomisedcontrollednoninferioritytrial AT hayalastaird topicalororalantibioticsforchildrenwithacuteotitismediapresentingwitheardischargestudyprotocolofarandomisedcontrollednoninferioritytrial AT littlepaul topicalororalantibioticsforchildrenwithacuteotitismediapresentingwitheardischargestudyprotocolofarandomisedcontrollednoninferioritytrial AT mooremichaelv topicalororalantibioticsforchildrenwithacuteotitismediapresentingwitheardischargestudyprotocolofarandomisedcontrollednoninferioritytrial AT sanderselisabetham topicalororalantibioticsforchildrenwithacuteotitismediapresentingwitheardischargestudyprotocolofarandomisedcontrollednoninferioritytrial AT bontenmarcjm topicalororalantibioticsforchildrenwithacuteotitismediapresentingwitheardischargestudyprotocolofarandomisedcontrollednoninferioritytrial AT bogaertdebby topicalororalantibioticsforchildrenwithacuteotitismediapresentingwitheardischargestudyprotocolofarandomisedcontrollednoninferioritytrial AT schilderannegm topicalororalantibioticsforchildrenwithacuteotitismediapresentingwitheardischargestudyprotocolofarandomisedcontrollednoninferioritytrial AT damoiseauxrogeramj topicalororalantibioticsforchildrenwithacuteotitismediapresentingwitheardischargestudyprotocolofarandomisedcontrollednoninferioritytrial |