scholarly journals Are topical antibiotics an alternative to oral antibiotics for children with acute otitis media and ear discharge?

BMJ ◽  
2016 ◽  
pp. i308 ◽  
Author(s):  
Roderick P Venekamp ◽  
Vibhore Prasad ◽  
Alastair D Hay
Keyword(s):  
Otitis Media ◽  
Acute Otitis Media ◽  
Oral Antibiotics ◽  
Topical Antibiotics

scholarly journals Immediate oral versus immediate topical versus delayed oral antibiotics for children with acute otitis media with discharge: the REST three-arm non-inferiority electronic platform-supported RCT

2021 ◽  
Vol 25 (67) ◽  
pp. 1-76
Author(s):  
Alastair D Hay ◽  
Michael V Moore ◽  
Jodi Taylor ◽  
Nicholas Turner ◽  
Sian Noble ◽  
...  
Keyword(s):  
Primary Care ◽  
Otitis Media ◽  
Symptom Management ◽  
Acute Otitis Media ◽  
Clinical Effectiveness ◽  
Health Technology ◽  
Symptom Duration ◽  
Oral Antibiotics ◽  
Topical Antibiotics ◽  
Internal Pilot

Background Acute otitis media is a painful infection of the middle ear that is commonly seen in children. In some children, the eardrum spontaneously bursts, discharging visible pus (otorrhoea) into the outer ear. Objective To compare the clinical effectiveness of immediate topical antibiotics or delayed oral antibiotics with the clinical effectiveness of immediate oral antibiotics in reducing symptom duration in children presenting to primary care with acute otitis media with discharge and the economic impact of the alternative strategies. Design This was a pragmatic, three-arm, individually randomised (stratified by age < 2 vs. ≥ 2 years), non-inferiority, open-label trial, with economic and qualitative evaluations, supported by a health-record-integrated electronic trial platform [TRANSFoRm (Translational Research and Patient Safety in Europe)] with an internal pilot. Setting A total of 44 English general practices. Participants Children aged ≥ 12 months and < 16 years whose parents (or carers) were seeking medical care for unilateral otorrhoea (ear discharge) following recent-onset (≤ 7 days) acute otitis media. Interventions (1) Immediate ciprofloxacin (0.3%) solution, four drops given three times daily for 7 days, or (2) delayed ‘dose-by-age’ amoxicillin suspension given three times daily (clarithromycin twice daily if the child was penicillin allergic) for 7 days, with structured delaying advice. All parents were given standardised information regarding symptom management (paracetamol/ibuprofen/fluids) and advice to complete the course. Comparator Immediate ‘dose-by-age’ oral amoxicillin given three times daily (or clarithromycin given twice daily) for 7 days. Parents received standardised symptom management advice along with advice to complete the course. Main outcome measure Time from randomisation to the first day on which all symptoms (pain, fever, being unwell, sleep disturbance, otorrhoea and episodes of distress/crying) were rated ‘no’ or ‘very slight’ problem (without need for analgesia). Methods Participants were recruited from routine primary care appointments. The planned sample size was 399 children. Follow-up used parent-completed validated symptom diaries. Results Delays in software deployment and configuration led to small recruitment numbers and trial closure at the end of the internal pilot. Twenty-two children (median age 5 years; 62% boys) were randomised: five, seven and 10 to immediate oral, delayed oral and immediate topical antibiotics, respectively. All children received prescriptions as randomised. Seven (32%) children fully adhered to the treatment as allocated. Symptom duration data were available for 17 (77%) children. The median (interquartile range) number of days until symptom resolution in the immediate oral, delayed oral and immediate topical antibiotic arms was 6 (4–9), 4 (3–7) and 4 (3–6), respectively. Comparative analyses were not conducted because of small numbers. There were no serious adverse events and six reports of new or worsening symptoms. Qualitative clinician interviews showed that the trial question was important. When the platform functioned as intended, it was liked. However, staff reported malfunctioning software for long periods, resulting in missed recruitment opportunities. Troubleshooting the software placed significant burdens on staff. Limitations The over-riding weakness was the failure to recruit enough children. Conclusions We were unable to answer the main research question because of a failure to reach the required sample size. Our experience of running an electronic platform-supported trial in primary care has highlighted challenges from which we have drawn recommendations for the National Institute for Health Research (NIHR) and the research community. These should be considered before such a platform is used again. Trial registration Current Controlled Trials ISRCTN12873692 and EudraCT 2017-003635-10. Funding This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 67. See the NIHR Journals Library website for further project information.

scholarly journals 732. Description of Diagnoses and Antibiotic Management of Otitis Media and Otitis Externa in Adults

2018 ◽  
Vol 5 (suppl_1) ◽  
pp. S263-S263
Author(s):  
Benjamin Pontefract ◽  
Karl Madaras-Kelly ◽  
McKenna Nevers ◽  
Katherine Fleming-Dutra ◽  
Matthew Samore
Keyword(s):  
Otitis Media ◽  
Otitis Externa ◽  
Otitis Media With Effusion ◽  
Acute Otitis Media ◽  
Incidence Density ◽  
Antibiotic Prescribing ◽  
Oral Antibiotic ◽  
Oral Antibiotics ◽  
Similar Frequency ◽  
Antibiotic Management

Abstract Background Otitis diagnoses include acute otitis media (AOM), otitis media with effusion (OME), and acute otitis externa (AOE). AOM and OME occur primarily in children, whereas AOE occurs with similar frequency in children and adults. Treatment with amoxicillin or close observation without antibiotics is recommended for pediatric AOM, and oral antibiotics are not routinely recommended to treat OME or uncomplicated AOE. Data on otitis diagnoses in adults is limited. This study’s purpose is to characterize the incidence and antibiotic management of otitis diagnoses in adults. Methods. A retrospective cohort of ambulatory veterans who presented at one of six VA Medical Centers during years 2014–2016 with an ICD-9 or -10 code for AOM, OME, and AOE diagnoses was developed. Data extracted included demographics, vital signs, diagnoses, and antibiotic prescriptions. Incident density rates for adult AOM, OME, and AOE were calculated and compared with rates for acute rhinosinusitis. Antibiotic prescribing rates were calculated. Results. Of 4,759 otitis visits identified, the most frequent diagnoses included AOM (38%), OME (25%), and AOE (34%). A single otitis diagnosis was coded in 95.6% of visits and 13.0% had co-diagnosis of another acute respiratory infection (ARI). The incidence density (±95% confidence interval) was 5.4 (5.2, 5.7), 3.6 (3.5, 3.9), and 4.9 (4.7, 5.2) cases per 1,000 patient-years for AOM, OME, and AOE, respectively. For comparison, the incidence density of rhinosinusitis was 16.6 (16.2, 17.0) cases per 1,000 patient-years. Oral antibiotics were prescribed in 48% of visits: AOM (50%), OME (49%), and AOE (47%). Topical antibiotics were prescribed in 32% of AOE visits. The most common oral and otic antibiotics prescribed were amoxicillin/clavulanate (36%), amoxicillin (28%), azithromycin (11%), and hydrocortisone/neomycin/polymyxin (65%), respectively. Conclusion. Otitis diagnoses in adults were common independent of ARI co-diagnoses, but less frequent than rhinosinusitis. Almost half of the patients received an oral antibiotic including those with AOE and OME, indicating a possible focus for antibiotic stewardship programs. Studies to evaluate diagnostic accuracy and treatment of otitis diagnoses in adults are needed. Disclosures All authors: No reported disclosures.

Pharmacology of Oral Antibiotics Used for Treatment of Otitis Media and Tonsillopharyngitis in Infants and Children

1981 ◽  
Vol 90 (3_suppl2) ◽  
pp. 37-43 ◽  
Author(s):  
Charles M. Ginsburg ◽  
George H. McCracken ◽  
John D. Nelson
Keyword(s):  
Otitis Media ◽  
Middle Ear ◽  
Acute Otitis Media ◽  
Infants And Children ◽  
Penicillin G ◽  
Oral Antibiotics ◽  
Erythromycin Estolate ◽  
In Infants And Children

Data are presented from pharmacologic evaluations of major oral antibiotics used in treatment of acute otitis media and tonsillopharyngitis in children. Information is included on serum and middle ear specimens obtained almost simultaneously following administration of many of these antibiotics. Discussion covers ampicillin and amoxicillin, penicillin G and V, erythromycin estolate, erythromycin ethylsuccinate and the orally administered cephalosporins.

Microbiology of Acute Otitis Media with Tympanostomy Tubes

2005 ◽  
Vol 133 (4) ◽  
pp. 585-595 ◽  
Author(s):  
Peter S. Roland ◽  
David A. Parry ◽  
David W. Stroman
Keyword(s):  
Staphylococcus Aureus ◽  
Pseudomonas Aeruginosa ◽  
Otitis Media ◽  
Acute Otitis Media ◽  
Tympanostomy Tube ◽  
Oral Antibiotics ◽  
Streptococcus Pneumonia ◽  
Tympanostomy Tubes ◽  
Fungal Organisms ◽  
Ear Drops

OBJECTIVE: The objective was to determine the types of organisms which cause acute otitis media with a tympanostomy tube and to ascertain their frequency distribution. STUDY DESIGN AND SETTING: Prospective, randomized, multi-institutional clinical trials. Both private and academic sites were included. RESULTS: 1309 isolates were recovered from 956 draining ears. Streptococcus pneumonia was recovered from 17%, Staphylococcus aureus from 13%, H flu from 18% and Pseudomonas aeruginosa from 12%. Fungal organisms were recovered from 5% of total isolates and 4% from single isolates. CONCLUSIONS: AOMT is microbiologically different than AOM with an intact TM. There is no evidence that resistance develops as result of topical treatment. SIGNIFICANCE: The study demonstrates that AOMT is frequently caused by organisms not susceptible to oral antibiotics approved for children, but which are sensitive to topical ear drops.

scholarly journals A multi-centre, pragmatic, three-arm, individually randomised, non-inferiority, open trial to compare Immediate Oral, Immediate Topical or Delayed Oral Antibiotics for Acute Otitis Media with Discharge in children: The Runny Ear Study (REST): Study protocol.

2020 ◽  
Author(s):  
Kathryn Curtis ◽  
Jodi Taylor ◽  
Alastair Hay ◽  
Michael Moore ◽  
Richard Morris ◽  
...  
Keyword(s):  
Primary Care ◽  
Data Collection ◽  
Otitis Media ◽  
Acute Otitis Media ◽  
Trial Registration ◽  
World Health ◽  
Oral Antibiotics ◽  
Management Platform ◽  
Oral Amoxicillin ◽  
The Uk

Abstract Background: Acute otitis media (AOM) is a common painful infection in children, with around 2.8 million cases presenting to primary care in England and Wales annually. Nearly all children who present to their general practitioner (GP) with AOM or AOM with discharge (AOMd) are treated with oral antibiotics. These can cause side effects; contribute to the growing problem of antimicrobial resistance, and more rarely, allergic reactions. Alternative treatments, such as an antibiotic eardrops or “delayed” oral antibiotics, could be at least as effective and safe as immediate oral antibiotics for children with AOMd.Methods: REST is a pragmatic, three-arm, individually randomised, non-inferiority trial being conducted in 50 GP practices across the UK. The study aims to recruit 399 children aged (≥12m and <16yrs) presenting to their GP with AOMd. Children will be randomised to one of three arms: immediate ciprofloxacin 0.3% eardrops; delayed oral amoxicillin (clarithromycin if penicillin allergic); or immediate oral amoxicillin (clarithromycin). Recruitment, including eligibility screening, randomisation and data collection, are conducted using the innovative, TRANSFoRm electronic trial management platform. Integrated within the primary care electronic medical records it provides automatic eligibility checking, part-filling of e-CRFs, study workflow management and routine NHS follow up data collection. The primary outcome is time to resolution of all significant symptoms and will be collected by the parent using a Symptom Recovery Questionnaire (SRQ). Secondary outcomes, including cost-effectiveness, duration of moderately bad or worse symptoms and repeat AOMd episodes, will be collected at day 14 and at 3 months. Discussion: It is unclear whether prescribing oral antibiotics to children with AoMd results in a reduction in symptoms or a shorter duration of illness. The REST trial will allow us to compare the non-inferiority of: immediate topical ciprofloxacin ear drops, or delayed oral amoxicillin (clarithromycin) against immediate oral amoxicillin (clarithromycin). We aim to recruit 399 patients from 175 practices in the UK. Using the Transform software to randomise participants to the trial will enable recruitment for a relatively uncommon condition. Trial registration:Name of Registry: ISCRTNRegistration Number: ISRCTN12873692 This contains all items required to comply with the World Health Organization Trial Registration Data SetDate of Registration: 24th April 2018 http://www.isrctn.com/ISRCTN12873692Name of Registry: EudraCT Registration Number: 2017-003635-10Date of Registration: 6TH September 2017

scholarly journals 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 ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e052128
Author(s):  
Saskia Hullegie ◽  
Roderick P Venekamp ◽  
Thijs M A van Dongen ◽  
Sanne Mulder ◽  
Willem van Schaik ◽  
...  
Keyword(s):  
The Netherlands ◽  
Adverse Events ◽  
Otitis Media ◽  
Acute Otitis Media ◽  
Healthcare Utilisation ◽  
Oral Antibiotics ◽  
Intention To Treat ◽  
Study Results ◽  
Scientific Meetings ◽  
Randomised Controlled

BackgroundAround 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 analysisA 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 disseminationThe 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 numberThe Netherlands National Trial Register; NTR6723. Date of registration: 27 November 2017.

scholarly journals A multi-centre, pragmatic, three-arm, individually randomised, non-inferiority, open trial to compare Immediate Oral, Immediate Topical or Delayed Oral Antibiotics for Acute Otitis Media with Discharge in children: The Runny Ear Study (REST): Study protocol.

2020 ◽  
Author(s):  
Kathryn Curtis ◽  
Michael Moore ◽  
Christie Cabral ◽  
Vasa Curcin ◽  
Jeremy Horwood ◽  
...  
Keyword(s):  
Primary Care ◽  
Data Collection ◽  
Otitis Media ◽  
Workflow Management ◽  
Acute Otitis Media ◽  
Oral Antibiotics ◽  
Trial Management ◽  
Management Platform ◽  
Oral Amoxicillin ◽  
The Uk

Abstract Background Acute otitis media (AOM) is a common painful infection in children, with around 2.8 million cases presenting to primary care in England and Wales annually. Nearly all children who present to their general practitioner (GP) with AOM or AOM with discharge (AOMd) are treated with oral antibiotics. These can cause side effects; contribute to the growing problem of antimicrobial resistance, and more rarely, allergic reactions. Alternative treatments, such as an antibiotic eardrops or “delayed” oral antibiotics, could be at least as effective and safe as immediate oral antibiotics for children with AOMd. Methods REST is a pragmatic, three-arm, individually randomised, non-inferiority trial being conducted in 50 GP practices across the UK. The study aims to recruit 399 children aged (≥12m and <16yrs) presenting to their GP with AOMd. Children will be randomised to one of three arms: immediate ciprofloxacin 0.3% eardrops; delayed oral amoxicillin (clarithromycin if penicillin allergic); or immediate oral amoxicillin (clarithromycin). Recruitment, including eligibility screening, randomisation and data collection, are conducted using the innovative, TRANSFoRm electronic trial management platform. Integrated within the primary care electronic medical records it provides automatic eligibility checking, part-filling of e-CRFs, study workflow management and routine NHS follow up data collection. The primary outcome is time to resolution of all significant symptoms and will be collected by the parent using a Symptom Recovery Questionnaire (SRQ). Secondary outcomes, including cost-effectiveness, duration of moderately bad or worse symptoms and repeat AOMd episodes, will be collected at day 14 and at 3 months. Discussion It is unclear whether prescribing oral antibiotics to children with AoMd results in a reduction in symptoms or a shorter duration of illness. The REST trial will allow us to compare the non-inferiority of: immediate topical ciprofloxacin ear drops, or delayed oral amoxicillin (clarithromycin) against immediate oral amoxicillin (clarithromycin). We aim to recruit 399 patients from 175 practices in the UK. Using the Transform software to randomise participants to the trial will enable recruitment for a relatively uncommon condition.

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