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 s...
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BMJ Publishing Group
2021-12-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/11/12/e052128.full |
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| author | Anne GM Schilder Alastair D Hay Marc J M Bonten Michael V Moore G Ardine de Wit Debby Bogaert Roderick P Venekamp Roger A M J Damoiseaux Elisabeth A M Sanders Saskia Hullegie Thijs M A van Dongen Sanne Mulder Willem van Schaik |
| author_facet | Anne GM Schilder Alastair D Hay Marc J M Bonten Michael V Moore G Ardine de Wit Debby Bogaert Roderick P Venekamp Roger A M J Damoiseaux Elisabeth A M Sanders Saskia Hullegie Thijs M A van Dongen Sanne Mulder Willem van Schaik |
| author_sort | Anne GM Schilder |
| collection | DOAJ |
| 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 | Article |
| id | doaj-art-92cb0f3ecf6144ffab4a8ec00f2625ae |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2021-12-01 |
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| series | BMJ Open |
| spelling | doaj-art-92cb0f3ecf6144ffab4a8ec00f2625ae2025-08-20T01:59:16ZengBMJ Publishing GroupBMJ Open2044-60552021-12-01111210.1136/bmjopen-2021-052128Topical or oral antibiotics for children with acute otitis media presenting with ear discharge: study protocol of a randomised controlled non-inferiority trialAnne GM Schilder0Alastair D Hay1Marc J M Bonten2Michael V Moore3G Ardine de Wit4Debby Bogaert5Roderick P Venekamp6Roger A M J Damoiseaux7Elisabeth A M Sanders8Saskia Hullegie9Thijs M A van Dongen10Sanne Mulder11Willem van Schaik12National Institute for Health Research University College London Hospitals Biomedical Research Centre, London, UKCentre for Academic Primary Care, University of Bristol, Bristol, UKJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlandsprofessor of primary health care researchCentre for Nutrition, Prevention and Healthcare, National Institute of Public Health and the Environment (RIVM), Bilthoven, The NetherlandsDepartment of Paediatric Immunology and Infectious Diseases, Wilhelmina Children’s Hospital, University Medical Center Utrecht, Utrecht, The NetherlandsDepartment of General Practice and Nursing Science, Julius Center for Health Sciences and Primary Care, Utrecht, NetherlandsJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The NetherlandsCenter for Infectious Disease Control, National Institute for Public Health and the Environment, Bilthoven, NetherlandsJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The NetherlandsJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The NetherlandsParent and PPI contributor, Utrecht, the Netherlands3 Institute of Microbiology and Infection, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UKBackground 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.https://bmjopen.bmj.com/content/11/12/e052128.full |
| spellingShingle | Anne GM Schilder Alastair D Hay Marc J M Bonten Michael V Moore G Ardine de Wit Debby Bogaert Roderick P Venekamp Roger A M J Damoiseaux Elisabeth A M Sanders Saskia Hullegie Thijs M A van Dongen Sanne Mulder Willem van Schaik 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 |
| 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 |
| url | https://bmjopen.bmj.com/content/11/12/e052128.full |
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