Treatment Of Acute Otitis Media Research Articles

Urations of antibiotic treatment for acute otitis media and variability in prescribed durations across two large academic health systems.

Acute otitis media (AOM) accounts for roughly 25% of antibiotics prescribed to children annually. Despite national guidelines that recommend short (5-7 days) durations of antibiotics for children two years and older with AOM, most receive long (10-day) courses. This study aims to evaluate antibiotic durations prescribed for children aged 2-17 years with uncomplicated AOM across two pediatric academic health systems, and to assess the variability in prescribed durations between and within each system. Electronic medical record (EMR) data from 135 care locations at two health systems were retrospectively analyzed. Outpatient encounters for children aged 2-17 years with a diagnosis of AOM from 2019-2022 were included. The primary outcome was the percent of 5-day prescriptions. Secondary outcomes included the proportion of 7-day prescriptions, 10-day prescriptions, prescriptions for non-first line antibiotics, cases associated with treatment failure, AOM recurrence, and adverse drug events. Among 73,198 AOM encounters for children 2 years and older, 61,612 (84%) encounters resulted in an antibiotic prescription. Most prescriptions were for 10 days (45,689; 75%), 20% were for 7 days (12,060), and only 5% were for 5 days (3,144). Treatment failure, AOM recurrence, adverse drug events, hospitalizations, and office, emergency department or urgent care visits for AOM within 30 days after the index visit were rare. Despite national guidelines that recommend shorter durations for children with uncomplicated AOM, 75% of our cohort received 10-day durations. Shortening durations of therapy for AOM could reduce antibiotic exposure and should be a priority of pediatric antibiotic stewardship programs.

Investigating the potential of novasomes in improving the trans-tympanic delivery of niflumic acid for effective treatment of acute otitis media

Acute otitis media (AOM) is an infection that occurs in the middle ear and may cause complications and affect quality of life. The study focused on the preparation of niflumic acid (NA) loaded novasomes for the efficient treatment of AOM through trans-tympanic drug delivery. NA loaded novasomes were formulated using Span 60 with oleic acid or lauric acid as a free fatty acid (FFA). Novasomes were prepared via ethanol injection technique using D-optimal design to evaluate the influence of 3 independent variables on the novasomes’ characteristics which are: entrapment efficiency percent (EE%), particle size (PS), polydispersity index (PDI), and zeta potential (ZP), and identify the best formula for additional investigations. The best formula determined was (N6) which contains 50 mg Span 60 and 50 mg oleic acid used as FFA. N6 exhibited EE% = 92.96 ± 0.37 %, PS = 389.25 ± 1.77 nm, PDI = 0.34 ± 0.00, and ZP = −40.90 ± 0.28 mV. N6 had a spherical shape with high elasticity. Also, it showed a sustained in vitro release compared to NA suspension. Additionally, in vivo investigations against AOM in rats and a histopathological study ensured the therapeutic effectiveness and safety of N6 and its superiority over NA suspension. Mostly, the findings showed the great efficacy of novasomes for trans-tympanic delivery of NA for the treatment of middle ear inflammation.

Latent mastoiditis (literature review)

Introduction. Mastoiditis is an extracranial complication of acute or chronic purulent otitis media, leading to periostitis or osteitis of the mastoid process, accompanied by obvious symptoms and requiring urgent surgical treatment. Latent mastoiditis is defined as a stage of local inflammation due to acute otitis media, without an obvious clinical picture of progressive destruction of the bone cells of the mastoid process. Recently, there has been a trend towards an increase in indolent forms of mastoiditis. The use of systemic antibiotic therapy for the treatment of acute otitis media complicates timely diagnosis and contributes to the chronicity of inflammation in the structures of the temporal bone. Making a diagnosis of latent mastoiditis requires vigilance from outpatient clinicians and the use of objective imaging methods due to the risk of developing intracranial complications.Aim. Conduct a review of literature sources to determine diagnostic criteria for the formation of latent mastoiditis in outpatient patients.Materials and methods. A search was carried out for articles from public databases using the query: “latent mastoiditis”, including data from literary sources whose authors made a significant contribution to the development of otorhinolaryngology. Summary data of the literature review, including both original studies and descriptions of clinical cases, identifying the main causes of the formation of latent mastoiditis and its clinical symptoms.Results and discussion. Local inflammation of the mastoid process, due to acute otitis media, has a progressive course of chronic sluggish inflammation of the bone structures of the temporal bone. Diagnosis of latent mastoiditis causes difficulties for practical healthcare doctors due to subtle clinical manifestations, and therefore it is necessary to determine the indications for referral to computed tomography.Conclusion. The medical and social significance of latent mastoiditis is that it has an unfavorable not only functional, but sometimes life prognosis, as it can cause the development of intracranial complications.

A rapid simultaneous antigen detection of Haemophilus influenzae and Streptococcus pneumoniae for predicting the prognosis of acute otitis media

BackgroundRapid identification of causative bacteria in treatment of acute otitis media (AOM) is of paramount importance for appropriate antibiotic use. Materials and methodsThis prospective observational study was conducted in 15 hospitals and clinics in Japan between 2018 and 2020. A new rapid antigen test kit (AOS-116), which simultaneously detects antigens for Streptococcus pneumoniae (Sp) and Haemophilus influenzae (Hi), was applied for middle ear fluids (MEFs) and nasopharyngeal secretions (NPSs) in patients with moderate to severe AOM. We investigated relationship between the results of rapid test, severity at initial visit, and clinical course. ResultsRegarding performance accuracy based on culture results, AOS-116 showed 1) high (>80%) sensitivity, specificity, and negative predictive value (NPV) in MEFs for both antigens, 2) high sensitivity, specificity, and positive predictive value (PPV) in NPSs for Hi antigen, and 3) high specificity, and PPV in NPSs for Sp antigen. Regarding predictive value of nasopharyngeal culture and antigen detection for causative middle ear pathogens, similar results were observed between AOS-116 and culture, which was characterized with high sensitivity and NPV for both pathogens. MEFs/NPSs positive for Hi antigen were significantly associated with eardrum findings, and severity. MEFs/NPSs positive for pneumococcal antigen were significantly associated with severity of otalgia, fever, and otorrhea. Among patients with prior antimicrobial treatment, improvement tended to be slower in cases positive for Hi than in cases negative. ConclusionThe rapid antigen detection test is useful as a decision-making tool for prescribing antimicrobial agents and may play an important role in promoting appropriate antimicrobial use.

Bacterial pathogens and antimicrobial resistance in acute otitis media

IntroductionRecent studies show an increase in the prevalence of Haemophilus influenzae and a decrease in Streptococcus pneumoniae among the bacteria that cause acute otitis media (AOM). The objective of our study was to analyse the distribution of pathogens identified in children aged less than 14 years presenting to the emergency department with AOM and their patterns of antimicrobial resistance. Patients and methodsSingle centre retrospective, analytical study in patients aged less than 14 years with a diagnosis of AOM in whom an ear drainage sample was collected for culture in the paediatric emergency department of a tertiary care hospital between 2013 and 2021. ResultsDuring the study period, there were 14 684 documented care episodes corresponding to children with a diagnosis of AOM. An ear drainage culture was performed in 768 of those episodes. The median age of the patients was 2 years, 57% were male and 70% had a previous history of AOM. The most frequently isolated pathogens were: Haemophilus influenzae (n = 188 [24.5%]; 15.5% of them resistant to ampicillin), Streptococcus pyogenes (n = 86 [11.2%]), Staphylococcus aureus (n = 82 [10.7%]), Streptococcus pneumoniae (n = 54 [6.9%]; 9.4% with intermediate resistance to penicillin), Pseudomonas aeruginosa (n = 42 [5.5%]) and Moraxella catarrhalis (n = 11 [1.4%]). No pathogen was isolated in 34.9% of cases. ConclusionsHaemophilus influenzae is the leading cause of AOM in children aged less than 14 years. This, combined with the low frequency of isolation and penicillin resistance of Streptococcus pneumoniae, calls into question the appropriateness of high-dose amoxicillin for empiric treatment of AOM.

Clinical Outcomes Associated with Amoxicillin Treatment for Acute Otitis Media in Children.

Acute otitis media (AOM) is the most common reason children are prescribed antibiotics. Bacteria that produce beta-lactamase are an increasingly frequent cause of AOM and may be resistant to amoxicillin, the currently recommended treatment for AOM. We aimed to evaluate the clinical outcomes of children treated with amoxicillin for AOM and assessed whether outcomes vary by infecting pathogen or beta-lactamase production. 205 children 6-35 months old diagnosed with AOM and prescribed amoxicillin were included. Bacterial culture and qualitative multiplex real-time polymerase chain reaction were performed on nasopharyngeal swabs collected at enrollment. Parents completed surveys assessing symptoms, antibiotic adherence, and potential adverse events. The primary outcome was treatment failure with amoxicillin. Secondary outcomes included recurrence, symptom improvement, resolution, and adverse drug events (ADE). 8 children (5.4%) experienced treatment failure and 14 (6.8%) had recurrence. By day 5, 152 (74.1%) children had symptom improvement and 97 (47.3%) had resolution. Parents reported ADE for 56 (27.3%) children. Among 149 children who did not take any amoxicillin before enrollment, 98 (65.8%) had one or more beta-lactamase-producing bacteria. Common bacterial otopathogens were Moraxella catarrhalis (79, 53.0%), Streptococcus pneumoniae (51, 34.2%), Haemophilus influenzae (30, 20.1%), and Staphylococcus aureus (21, 14.1%). Treatment failure did not differ between children that did (5, 5.1%) and did not (3, 5.9%) have beta-lactamase-producing otopathogens (p = .05). Among children diagnosed with AOM treated with amoxicillin, treatment failure was uncommon and did not differ by pathogen or beta-lactamase production. These data support guidance recommending amoxicillin despite an increasing prevalence of beta-lactamase-producing bacteria.

Patógenos bacterianos y resistencia a los antibióticos en otitis media aguda

IntroductionRecent studies show an increase in the prevalence of Haemophilus influenzae and a decrease in Streptococcus pneumoniae among the bacteria that cause acute otitis media (AOM). The objective of our study was to analyse the distribution of pathogens identified in children aged less than 14 years presenting to the emergency department with AOM and their patterns of antimicrobial resistance. Patients and methodsSingle centre retrospective, analytical study in patients aged less than 14 years with a diagnosis of AOM in whom an ear drainage sample was collected for culture in the paediatric emergency department of a tertiary care hospital between 2013 and 2021. ResultsDuring the study period, there were 14,684 documented care episodes corresponding to children with a diagnosis of AOM. An ear drainage culture was performed in 768 of those episodes. The median age of the patients was 2 years, 57% were male and 70% had a previous history of AOM. The most frequently isolated pathogens were: Haemophilus influenzae (n=188 [24.5%]; 15.5% of them resistant to ampicillin), Streptococcus pyogenes (n=86 [11.2%]), Staphylococcus aureus (n=82 [10.7%]), Streptococcus pneumoniae (n=54 [6.9%]; 9.4% with intermediate resistance to penicillin), Pseudomonas aeruginosa (n=42 [5.5%]) and Moraxella catarrhalis (n=11 [1.4%]). No pathogen was isolated in 34.9% of cases. ConclusionsHaemophilus influenzae is the leading cause of AOM in children aged less than 14 years. This, combined with the low frequency of isolation and penicillin resistance of Streptococcus pneumoniae, calls into question the appropriateness of high-dose amoxicillin for empiric treatment of AOM

Watchful Waiting Strategy in the Treatment of Acute Otitis Media in Children

Background: Acute otitis media (AOM) is a common issue among children, often requiring antibiotic treatment. It is crucial to explore methods for the rational use of antibiotics. This study aimed to assess the effectiveness of the watchful waiting approach in treating children aged 6 months to 18 years with mild to moderate AOM. Methods: This prospective quasi-experimental study was conducted on 100 children with mild to moderate AOM. All patients, except those in severe or critical conditions, were placed on the watchful waiting strategy. A follow-up was conducted after 48 - 72 hours. If symptoms had improved, the watchful waiting approach continued. If medication was necessary for various reasons, these reasons were documented. Subsequently, children who completed the watchful waiting strategy were compared to those who received antibiotics. The collected data were analyzed using chi-square and t-tests in SPSS Statistics for Windows (version 16.0). Results: In this study, 59 patients (59%) were treated with the watchful waiting approach; nevertheless, 41 patients (41%) received antibiotics. The presence or absence of postnasal discharge showed a significant difference between the two groups (P = 0.001). No significant differences were observed between the two groups regarding fever (P = 0.066), enlarged tonsils (P = 0.740), snoring (P = 0.252), and bilateral involvement of the tympanic membrane (P = 0.313). Conclusions: Based on the results, the watchful waiting strategy is a cost-effective method for children aged over 6 months with mild to moderate symptoms, provided that parents cooperate fully. Clinicians should be cautious and consider alternative treatments if postnasal discharge is present, as it might indicate a higher likelihood of treatment failure with the watchful waiting approach.

Treatment of Acute Otitis Media with Inner Ear Involvement in Adults.

Inner ear involvement (IED) is a rare local complication of the very common acute otitis media (AOM). The most beneficial treatment for IED remains a matter of debate. The aim of this study is to analyze different treatment modalities based on hearing outcomes to contribute to the discussion of therapy for IED in AOM. This retrospective study includes 112 adult patients diagnosed with AOM with IED between 2000 and 2020. Patients either received conservative (systemic antibiotic and systemic steroid therapy), interventional (conservative plus myringotomy and tympanic tube) or operative (interventional plus antrotomy) treatment. Pre- and post-treatment pure tone audiometry was performed. The hearing outcome was compared, and hearing recovery was analyzed based on modified Siegel's criteria. The pre-treatment pure tone average (PTA) was significantly (p < 0.05) higher in the operative group than in the other groups. All treatment modalities led to a significant hearing improvement (p < 0.001). The pre- and post-treatment hearing loss was predominantly observed in high frequencies 2-4 kHz. The operative group showed the highest rate of complete hearing recovery. While all treatment modalities led to a significant improvement in hearing, the operative group showed the most beneficial hearing results in patients with high pre-treatment hearing loss. It remains to be shown if the findings in patients with high pre-treatment hearing loss can be generalized to patients with mild or moderate pre-treatment hearing loss.

Questions of systemic and topical antibacterial therapy of acute rhinosinusitis in a child

Background. Acute otitis media is the most common complication of acute respiratory viral infection in children under 6 years of age. More than 90% of children suffer from acute otitis media in the first 5 years of life. Ear pain is one of the main symptoms of acute otitis media and determines the patient's well-being.&#x0D; Aim. To evaluate the efficacy and tolerability of the use of ear drops based on the combination of phenazone and lidocaine in the local therapy of acute otitis media in the preperforative stage in children.&#x0D; Materials and methods. A retrospective analysis of the outpatient records of 50 patients with complaints of symptoms of acute otitis media was performed.&#x0D; Results. Based on the analysis of medical records, it was found that the use of ear drops based on a combination of phenazone and lidocaine can significantly reduce the severity of ear pain in acute otitis media within 3 minutes. The use of ear drops based on the combination of phenazone and lidocaine for a course of 7 days allows most patients to abandon the use of systemic forms of analgesics. No patient has been reported to have developed adverse events associated with the use of phenazone-lidocaine combination ear drops.&#x0D; Conclusion. The use of ear drops based on a fixed combination of lidocaine + phenazone is not only a highly effective and safe drug for the treatment of acute otitis media in the preperforative stage in children, but also a fast symptomatic therapy, which physicians after otoscopy can use as the method of choice to reduce patients' ear pain already during the initial examination.

The 2022 to 2023 Amoxicillin Shortage and Acute Otitis Media Treatment.

The 2022 to 2023 Amoxicillin Shortage and Acute Otitis Media Treatment.

Documented Penicillin Allergies on Antibiotic Selection at Pediatric Emergency Department Visits.

Penicillin or amoxicillin are the recommended treatments for the most common pediatric bacterial illnesses. Allergies to penicillin are commonly reported among children but rarely true. We evaluated the impact of reported penicillin allergies on broad-spectrum antibiotic use overall and for the treatment of common respiratory infections among treat-and-release pediatric emergency department (ED) visits. Retrospective cohort study of pediatric patients receiving antibiotics during a treat-and-release visit at a large, pediatric ED in the northeast from 2014 to 2016. Study exposure was a reported allergy to penicillin in the electronic medical record. Study outcomes were the selection of broad-spectrum antibiotics and alternative (second-line) antibiotic therapy for the treatment of acute otitis media (AOM) and group A streptococcus (GAS) pharyngitis. We used unadjusted and adjusted generalized estimating equation models to analyze the impact of reported penicillin allergies on the selection of broad-spectrum antibiotics. We used unadjusted and adjusted logistic regression models to determine the probability of children with a documented penicillin allergy receiving alternative antibiotic treatments for AOM and GAS. Among 12,987 pediatric patients, 810 (6.2%) had a documented penicillin allergy. Penicillin allergies increased the odds of children receiving a broad spectrum versus narrow spectrum antibiotic (adjusted odds ratio, 13.55; 95% confidence interval (CI), 11.34-16.18). In our adjusted logistic regression model, the probability of children with a documented penicillin allergy receiving alternative antibiotic treatment for AOM was 0.97 (95% CI, 0.94-0.99) and for GAS was 0.97 (95% CI, 0.92-0.99). Antibiotic stewardship efforts in pediatric EDs may consider the delabeling of penicillin allergies particularly among children receiving antibiotics for an acute respiratory infection as a target for intervention.

Evaluation and Comparison of Audiometric Findings Before and After Treatment in Acute Otitis Media

Evaluation and Comparison of Audiometric Findings Before and After Treatment in Acute Otitis Media

Parental experiences and opinions regarding the management of acute otitis media in Finland-a comparative questionnaire between 2006 and 2019.

Treatment guidelines for acute otitis media (AOM) have changed over the past 20 years. Watchful waiting is often recommended as an option for antibiotic treatment and the use of proper pain medication is emphasised. To study parental experiences and opinions regarding the management of AOM and compare our findings with our previous questionnaire submitted in 2006. We sent an online survey link through day-care centres and Facebook parental groups in Turku area. Children <4 years of age attending day care were included in the analysis. We asked about the child's history of AOM, parental opinions about AOM treatment, and antibiotic resistance. Results of 2019 were compared with those of 2006. Altogether 84% (320/381) and 83% (568/681) of children had had at least 1 episode of AOM in 2019 and 2006, respectively. In 2019, more children had been treated without antibiotics (30% vs. 13%, P < 0.001) and fewer parents thought that antibiotics are necessary for the treatment of AOM (70% vs. 85%, P < 0.001) compared with 2006. The use and knowledge of painkillers had increased over the past 13 years. Painkillers had been given at least once to 93% (296/320) of children in 2019 and 80% (441/552) of children in 2006 (P < 0.001). Today, more parents accept watchful waiting as a treatment option for AOM and give painkillers to their children, which indicates that the education about optimal management of AOM has reached parents.

Update of the consensus document on the aetiology, diagnosis and treatment of acute otitis media and sinusitis

Update of the consensus on acute otitis media (AOM) (2012) and sinusitis (2013) following the introduction of pneumococcal vaccines in the immunization schedule, and related changes, such as epidemiological variation, colonization by of nonvaccine serotypes and emerging antimicrobial resistances. A majority of studies show that the introduction of the pneumococcal 13-valent conjugate vaccine has been followed by a reduction in the nasopharyngeal carriage of pneumococcus, with an increase in the proportion of drug-resistant nonvaccine serotypes. The diagnosis of AOM is still clinical, although more stringent criteria are proposed, which are based on the visualization of abnormalities in the tympanic membrane and the findings of pneumatic otoscopy performed by trained clinicians. The routine diagnosis of sinusitis is also clinical, and the use of imaging is restricted to the assessment of complications. Analgesia with acetaminophen or ibuprofen is the cornerstone of AOM management; watchful waiting or delayed antibiotic prescription may be suitable strategies in select patients. The first-line antibiotic drug in children with AOM and sinusitis and moderate to severe disease is still high-dose amoxicillin, or amoxicillin-clavulanic acid in select cases. Short-course regimens lasting 5–7 days are recommended for patients with uncomplicated disease, no risk factors and a mild presentation. In allergic patients, the selection of the antibiotic agent must be individualized based on severity and whether or not the allergy is IgE-mediated. In recurrent AOM, the choice between watchful waiting, antibiotic prophylaxis or surgery must be individualized based on the clinical characteristics of the patient.

Comparative efficacy and optimal duration of first-line antibiotic regimens for acute otitis media in children and adolescents: a systematic review and network meta-analysis of 89 randomized clinical trials.

Antibiotic use for acute otitis media (AOM) is one of the major sources of antimicrobial resistance. However, the effective minimal antibiotic duration for AOM remains unclear. Moreover, guidelines often recommend broad ranges (5-10days) of antibiotic use, yet the clinical impact of such a wide window has not been assessed. We systematically searched PubMed/MEDLINE, Embase, Scopus, Web of Science, and Cochrane Library from database inception to 6 October 2021. Network meta-analysis was conducted on randomized controlled trials that assessed antibiotic treatment for AOM in children (PROSPERO CRD42020196107). For amoxicillin and amoxicillin-clavulanate, 7-day regimens were noninferior to 10-day regimens in clinical responses [amoxicillin: risk ratio (RR) 0.919 (95% CI 0.820-1.031), amoxicillin-clavulanate: RR 1.108 (0.957-1.282)], except for ≤ 2years. For the third-generation cephalosporins, 7-day and 10-day regimens had similar clinical responses compared to placebo [7-day: RR 1.420 (1.190-1.694), 10-day: RR 1.238 (1.125-1.362) compared to placebo]. However, 5-day regimens of amoxicillin-clavulanate and third-generation cephalosporins were inferior to 10-day regimens. Compared to amoxicillin, a shorter treatment duration was tolerable with amoxicillin-clavulanate. Our findings indicated that 10days of antibiotic use may be unnecessarily long, while the treatment duration should be longer than 5days. Otherwise, 5-day regimens would be sufficient for a modest treatment goal. Our findings revealed that the current wide range of recommended antibiotic durations may have influenced the clinical outcome of AOM, and a narrower antibiotic duration window should be re-established.

Modern aspects of immune protection of the middle ear in the pathogenesis of acute otitis media and its complications

The relevance of the study is due to the need for an extended search for information on the current state of the problem of acute otitis media in adults based on the experience of Ukrainian and foreign authors. The aim of our research: To analyze the world experience on the etiology, pathogenesis and diagnosis of acute otitis media in adults. Materials and methods: 125 modern literature sources of electronic databases PubMed, EMBASE, MED-LINE, U.S. National Library of Medicine Clinical Trials, Research Gate and Cochrane Library. Introduction: The problem of otitis media as a component of the problem of inflammatory diseases of the upper respiratory tract remains relevant in modern medicine, based on its incidence and prevalence in the structure of otolaryngological diseases. Despite the achievements of modern medical science, these indicators remain consistently substantial, which determines the relevance of further research to improve diagnosis and treatment. Results: By conducting a bibliographic method of research it was found that most scientific articles are devoted to the problem of acute otitis media in children, while the problem of acute otitis media in adults is not sufficiently studied. Clinical and experimental studies have established that the function of immune protection of the middle ear is present at almost all physiological levels from epithelial cells to intracellular nuclear factor. This function is realized through the messengers of the cytokine network. Among the pool of cytokines, IL-1, IL-6 and TNF-α are important for the pathogenesis of acute otitis media. One of the features of the immune defense is a clear succession of stages of inflammation with its own features at each stage. It is shown that each of the links of immune defense (including cytokines) is able to detect (in case of discrepancy in strength and time) a negative effect with the maintenance or intensification of inflammation. The data of experimental analysis of pathomorphological changes in the middle ear depending on the duration of the disease are presented. It is also shown that the issue of complicated course (in particular mastoiditis) is still relevant. The role of acute otitis media in the deveopment of intracranial complications (meningitis) has been established. The significance of comorbidity for the pathogenesis of acute otitis media and the role of diabetes mellitus in the structure of comorbidity was proved. The main factors of reducing the effectiveness of diagnosis and treatment of acute otitis media are convincingly outlined: the multifactorial nature of the etiology, the peculiarities of immune protection and the tendency of otopathogens to evade the host's immune response, the importance of comorbid pathology in adult pat ients with ENT diseases. A certain number of literature sources are devoted to the features of the course of acute otitis media in diabetes mellitus. The shortcoming identified by the results of the analysis of literature sources: the lack of research on the peculiarities of the clinic and diagnosis of acute otitis media in adults, especially in the setting of comorbid pathology, primarily type 2 diabetes mellitus, indicates the relevance of further research on this problem.

Efficacy and safety of 1.5% levofloxacin otic solution for the treatment of otitis media in a multicenter, randomized, double-blind, parallel-group, placebo-controlled, phase III study

ObjectiveThe present study aimed to evaluate the efficacy and safety of 1.5% levofloxacin (LVFX) otic solution for the treatment of patients with otitis media. MethodsThis multicenter, randomized, double-blind, parallel-group, placebo-controlled phase 3 trial was conducted at 34 institutions in Japan. A total of 202 patients with chronic suppurative otitis media (CSOM) or acute otitis media (AOM) were randomized into either the LVFX group or placebo group. A total of 6–10 drops of 1.5% otic solution of LVFX or its matching placebo were administered in the diseased ear twice daily, in the morning and evening for up to 10 days. Images corresponding to three clinical findings—purulent otorrhea, hyperemia (redness), and granulation tissue formation in the middle ear and tympanic membrane—for each diseased ear were evaluated using digital endoscopy by a blinded central independent review committee (BICRC) at each visit after treatment administration. ResultsIn total, the data of 201 participants (LVFX group, 99; placebo group, 102) were analyzed. The proportion of patients with disappearance (improvement rate) of all three clinical findings at the end of treatment or discontinuation by the BICRC was 46.5% (46/99) in the LVFX group and 23.5% (24/102) in the placebo group, and the difference (95% confidence interval) between the groups was 22.0% (8.7, 34.2), with a significantly higher improvement rate in the LVFX group than in the placebo group (p = 0.001; Cochran–Mantel–Haenszel test), demonstrating the efficacy of LVFX. The bacterial eradication rates were 93.9% (77/82) and 12.5% (11/88) in the LVFX and placebo groups, respectively, and the rate was significantly higher in the LVFX group than in the placebo group (p < 0.001). Treatment-related adverse events (AEs) occurred in 5.1% (5/99) and 7.8% (8/102) of the patients in the LVFX and placebo groups, respectively, and no significant difference was noted in incidence rate between the groups. ConclusionThe clinical efficacy of 1.5% LVFX otic solution for CSOM and AOM was demonstrated by the resolution of inflammation in the middle ear and tympanic membrane as well as through the high bacterial eradication rate observed. No deaths or serious treatment-related AEs were observed. The study provided confirmation that 1.5% LVFX otic solution is a safe, well-tolerated, and effective treatment for CSOM and AOM.

The epidemiology of cephalosporin allergy labels in pediatric primary care.

Recent studies have sought to understand the epidemiology and impact of beta-lactam allergy labels on children; however, most of these studies have focused on penicillin allergy labels. Fewer studies assess cephalosporin antibiotic allergy labels in children. The objective of this study was to determine the prevalence, factors associated with, and impact of cephalosporin allergy labels in children cared for in the primary care setting. Cephalosporin allergy labels were reviewed among children in a dual center, retrospective, birth cohort who were born between 2010 and 2020 and followed in 90 pediatric primary care practices. Antibiotic prescriptions for acute otitis media were compared in children with and without cephalosporin allergies. 334,465 children comprised the birth cohort and 2,877 (0.9%) were labeled as cephalosporin allergic during the study period at a median age of 1.6 years. Third-generation cephalosporins were the most common class of cephalosporin allergy (83.0%). Cephalosporin allergy labels were more common in children with penicillin allergy labels than those without (5.8% vs. 0.6%). Other factors associated with a cephalosporin allergy label included white race, private insurance, presence of a chronic condition, and increased health care utilization. Children with third-generation cephalosporin allergy labels received more amoxicillin/clavulanate (28.8% vs. 10.2%) and macrolides (10.4% vs. 1.9%) and less amoxicillin (55.8% vs. 70.9%) for treatment of acute otitis media than non-allergic peers p < 0.001. One in 100 children is labeled as cephalosporin allergic, and these children receive different antibiotics for the treatment of acute otitis media compared to non-allergic peers.

Обоснованность местной обезболивающей терапии при лечении острого среднего отита у детей

Acute otitis media (AOM) in children is one of the most common diseases. The provision of medical care in AOM is performed in accordance with the relevant clinical recommendations approved by the Ministry of Health of the Russian Federation. The article presents the risk factors concerning the AOM development in children, gives a brief description of the etiological factors and specifics about the pathogenetic mechanism. The clinical symptom patterns and diagnosis of AOM in infants are analyzed. In the treatment of AOM in children, antibiotics are prescribed more commonly than in other diseases. The article also considers the basic principles of prescribing systemic antibacterial drugs in AOM, as well as indications and benefits of using high doses of antibacterial drugs. In otalgia, the relief of ear pain is precisely the primary task. The positive role of topical otic anesthetics as first-line drugs is discussed, which helps to reduce the frequency of antibiotic use. Topical analgesic treatment in AOM is preferable because it avoids adverse events from systemic antibacterial drugs, and anesthesia may be faster, more intense and last longer versus oral analgesia. Special attention is paid to the description of the benefits, efficacy and safety of topical otic anesthetic drops with a combination of lidocaine + phenazone. The results of researches and clinical studies are presented, pathogenetically substantiating the expediency of using the lidocaine + phenazone combination in AOM and confirming its efficacy and safety. KEYWORDS: acute otitis media, conservative treatment, risk factors, clinical recommendations, phenazone, lidocaine, children. FOR CITATION: Karpova E.P., Belov V.A., Asmanov A.I. Validity of topical analgesic therapy in the treatment of acute otitis media in children. Russian Journal of Woman and Child Health. 2023;6(4):411–416 (in Russ.). DOI: 10.32364/2618-8430-2023-6-4-14