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Otitis media (OM) is amongst the most common childhood diseases and is associated with multiple microbial pathogens within the middle ear. Global and temporal monitoring of predominant bacterial pathogens is important to inform new treatment strategies, vaccine development and to monitor the impact of vaccine implementation to improve progress toward global OM prevention. A systematic review of published reports of microbiology of acute otitis media (AOM) and otitis media with effusion (OME) from January, 1970 to August 2014, was performed using PubMed databases. This review confirmed that Streptococcus pneumoniae and Haemophilus influenzae, remain the predominant bacterial pathogens, with S. pneumoniae the predominant bacterium in the majority reports from AOM patients. In contrast, H. influenzae was the predominant bacterium for patients experiencing chronic OME, recurrent AOM and AOM with treatment failure. This result was consistent, even where improved detection sensitivity from the use of polymerase chain reaction (PCR) rather than bacterial culture was conducted. On average, PCR analyses increased the frequency of detection of S. pneumoniae and H. influenzae 3.2 fold compared to culture, whilst Moraxella catarrhalis was 4.5 times more frequently identified by PCR. Molecular methods can also improve monitoring of regional changes in the serotypes and identification frequency of S. pneumoniae and H. influenzae over time or after vaccine implementation, such as after introduction of the 7-valent pneumococcal conjugate vaccine. Globally, S. pneumoniae and H. influenzae remain the predominant otopathogens associated with OM as identified through bacterial culture; however, molecular methods continue to improve the frequency and accuracy of detection of individual serotypes. Ongoing monitoring with appropriate detection methods for OM pathogens can support development of improved vaccines to provide protection from the complex combination of otopathogens within the middle ear, ultimately aiming to reduce the risk of chronic and recurrent OM in vulnerable populations.

Acute otitis media is one of the most commonly-diagnosed childhood infections. This study assessed the efficacy of a novel vaccine that contained polysaccharides from 11 different Streptococcus pneumoniae serotypes each conjugated to Haemophilus influenzae-derived protein D in prevention of acute otitis media. 4968 infants were randomly assigned to receive either pneumococcal protein D conjugate or hepatitis A vaccine at the ages of 3, 4, 5, and 12–15 months and were followed-up until the end of the second year of life. Middle-ear fluid was obtained for bacteriological culture and serotyping in children who presented with abnormal tympanic membrane or presence of middle-ear effusion, plus two predefined clinical symptoms. The primary endpoint was protective efficacy against the first episode of acute otitis media caused by vaccine pneumococcal serotypes. Analysis was per protocol. From 2 weeks after the third dose to 24–27 months of age, 333 clinical episodes of acute otitis media were recorded in the protein D conjugate group (n=2455) and 499 in the control group (n=2452), giving a significant (33·6% [95% CI 20·8–44·3]) reduction in the overall incidence of acute otitis media. Vaccine efficacy was shown for episodes of acute otitis media caused by pneumococcal vaccine serotypes (52·6% [35·0–65·5] for the first episode and 57·6% [41·4–69·3] for any episode). Efficacy was also shown against episodes of acute otitis media caused by non-typable H influenzae (35·3% [1·8–57·4]). The vaccine reduced frequency of infection from vaccine-related cross-reactive pneumococcal serotypes by 65·5%, but did not significantly change the number of episodes caused by other non-vaccine serotypes. These results confirm that using the H influenzae-derived protein D as a carrier protein for pneumococcal polysaccharides not only allowed protection against pneumococcal otitis, but also against acute otitis media due to non-typable H influenzae. Whether this approach would also allow improved protection against lower respiratory tract infections warrants further investigation.

Studying the impact of antibiotic treatment on otitis media (OM), the leading cause of primary care office visits during childhood, is critical to develop appropriate treatment strategies. Tracking dynamic middle ear conditions during antibiotic treatment is not readily applicable in patients, due to the limited diagnostic techniques available to detect the smaller amount and variation of middle ear effusion (MEE) and middle ear bacterial biofilm, responsible for chronic and recurrent OM. To overcome these challenges, a handheld optical coherence tomography (OCT) system has been developed to monitor in vivo response of biofilms and MEEs in the OM-induced chinchilla model, the standard model for human OM. As a result, the formation of MEE as well as biofilm adherent to the tympanic membrane (TM) was longitudinally assessed as OM developed. Various types of MEEs and biofilms in the chinchilla model were identified, which showed comparable features as those in humans. Furthermore, the effect of antibiotics on the biofilm as well as the amount and type of MEEs was investigated with low-dose and high-dose treatment (ceftriaxone). The capability of OCT to non-invasively track and examine middle ear conditions is highly beneficial for therapeutic OM studies and will lead to improved management of OM in patients.

Acute rhinosinusitis (ARS) in children may be accompanied by acute otitis media (AOM) which is often associated with bacterial co-infections. These conditions are among the primary reasons that children visit hospitals and require antibiotic treatment. This study evaluated the efficacy of the nasal-spraying probiotics (LiveSpo Navax containing 5 billion Bacillus subtilis and B. clausii spores/5 mL) as a supportive treatment for dual ARS and AOM with otorrhea in a randomized, single-blind, controlled clinical trial. Eighty-two patients (41 per group), aged 1 month to 12 years, received standard care along with nasal spraying of either physiological saline (Control group) or LiveSpo Navax (Navax group), administered three times daily over a 7-day follow-up period. A total of sixty-one patients (30–31 per group) completed the trial. The Navax group experienced 68.00% and 96.77% reductions in nasal congestion (by day 3) and rhinorrhea (by day 7), respectively, which were 2.04 and 1.94-fold higher than the Control group, with odds ratios (OR) of 4.31 and 30.00 ( p  < 0.05). Endoscopic results indicated 8% and 11% higher reductions in nasal mucopurulent discharge and tympanic membrane hyperemia in the Navax group compared to the Control group. By day 3, compared to day 0, the Navax group exhibited > 1200-fold reduction in Streptococcus pneumoniae and ≥ 4-fold reduction in Haemophilus influenzae concentrations ( p  < 0.05) in both nasopharyngeal and middle ear fluid samples, whereas the Control group showed no significant reductions. Navax treatment reduced IL-6 by 1.35- to 1.74-fold and TNF-α by 1.17- to 1.45-fold, more effectively than the Control group ( p  < 0.05). These results suggest that nasal-spray Bacillus spore probiotics, with their ability to reduce bacterial load and modulate immune responses, provide a cost-effective and safe solution for alleviating symptoms of both ARS and AOM in children. Trial registration : ClinicalTrials.gov, Identifier NCT05804123 on April 7, 2023.

The relationship between pneumococcal conjugate vaccine-induced antibody responses and protection against community-acquired pneumonia (CAP) and acute otitis media (AOM) is unclear. This study assessed the impact of the ten-valent pneumococcal nontypable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) on these end points. The primary objective was to demonstrate vaccine efficacy (VE) in a per-protocol analysis against likely bacterial CAP (B-CAP: radiologically confirmed CAP with alveolar consolidation/pleural effusion on chest X-ray, or non-alveolar infiltrates and C-reactive protein ≥ 40 µg/ml); other protocol-specified outcomes were also assessed. This phase III double-blind randomized controlled study was conducted between 28 June 2007 and 28 July 2011 in Argentine, Panamanian, and Colombian populations with good access to health care. Approximately 24,000 infants received PHiD-CV or hepatitis control vaccine (hepatitis B for primary vaccination, hepatitis A at booster) at 2, 4, 6, and 15-18 mo of age. Interim analysis of the primary end point was planned when 535 first B-CAP episodes, occurring ≥2 wk after dose 3, were identified in the per-protocol cohort. After a mean follow-up of 23 mo (PHiD-CV, n = 10,295; control, n = 10,201), per-protocol VE was 22.0% (95% CI: 7.7, 34.2; one-sided p = 0.002) against B-CAP (conclusive for primary objective) and 25.7% (95% CI: 8.4%, 39.6%) against World Health Organization-defined consolidated CAP. Intent-to-treat VE was 18.2% (95% CI: 5.5%, 29.1%) against B-CAP and 23.4% (95% CI: 8.8%, 35.7%) against consolidated CAP. End-of-study per-protocol analyses were performed after a mean follow-up of 28-30 mo for CAP and invasive pneumococcal disease (IPD) (PHiD-CV, n = 10,211; control, n = 10,140) and AOM (n = 3,010 and 2,979, respectively). Per-protocol VE was 16.1% (95% CI: -1.1%, 30.4%; one-sided p = 0.032) against clinically confirmed AOM, 67.1% (95% CI: 17.0%, 86.9%) against vaccine serotype clinically confirmed AOM, 100% (95% CI: 74.3%, 100%) against vaccine serotype IPD, and 65.0% (95% CI: 11.1%, 86.2%) against any IPD. Results were consistent between intent-to-treat and per-protocol analyses. Serious adverse events were reported for 21.5% (95% CI: 20.7%, 22.2%) and 22.6% (95% CI: 21.9%, 23.4%) of PHiD-CV and control recipients, respectively. There were 19 deaths (n = 11,798; 0.16%) in the PHiD-CV group and 26 deaths (n = 11,799; 0.22%) in the control group. A significant study limitation was the lower than expected number of captured AOM cases. Efficacy was demonstrated against a broad range of pneumococcal diseases commonly encountered in young children in clinical practice. www.ClinicalTrials.gov NCT00466947.

Introduction Malignant otitis externa (MOE) is a life-threatening infection of the external auditory canal and temporal bone. Objective This study is designed to identify the clinical features, predisposing factors, radiological findings, complications, diagnoses, and management of MOE patients. Study design Retrospective cross-sectional study. Setting Loghman-e-Hakim Hospital, Tehran, Iran. Methods The study included 40 patients diagnosed with MOE from 2011 to 2023. The data extracted from medical records included demographic data, clinical signs and symptoms, radiological findings, laboratory data, predisposing factors, complications, treatments, and outcomes. Out of 37 patients, 21 were followed up. Results The study found that the mean age of patients was 62.24 ± 11.44 years, with 62.2% being male. Otalgia and otorrhea were the most commonly reported symptoms, and mastoiditis was the most common radiological finding. Bone erosions and osteomyelitis were other important complications. Vascular complications were also observed in 7 patients. The study also found that most patients had underlying conditions such as diabetes mellitus, hypertension, ischemic heart disease, and renal disease. One patient passed away during hospitalization, while others improved and were discharged. Then, at follow-up, 11 patients died, mainly due to the progression of underlying disorders including cardiac, and renal manifestations. Conclusion Based on our findings, although MOE most commonly occurs in poorly-controlled diabetic or immunocompromised patients, it can also occur in individuals without known conditions. Furthermore, increasing the age and severity of DM could lead to more complications. In terms of medical therapy, coverage of gram-positive bacteria and an antipseudomonal regimen would be an effective treatment.

Necrotising otitis externa is an aggressive infection of the external ear, which extends to the surrounding bone and soft tissue. In recent years, there has been an apparent increase in the number of patients admitted to our hospital with this condition. A retrospective review was conducted of all patients admitted to our hospital with necrotising otitis externa between July 2012 and June 2020. Among 39 patients included, only 9 were diagnosed in the first four years, and 30 were diagnosed in the last four years. There were 27 males and 12 females, and the mean age was 78.7 years. There were six non-diabetic immunocompetent patients. Cranial nerve palsies developed in 50 per cent of the patients. Disease-related mortality was 7.7 per cent. A favourable outcome was recorded in 66.7 per cent of the patients. Necrotising otitis externa is associated with high morbidity and mortality. The incidence of the disease is rising in our local geographical area.

This trial randomly assigned children 6 to 35 months of age who had a history of multiple episodes of acute otitis media to either undergo tympanostomy-tube placement or receive medical management. The rate of episodes of acute otitis media during a 2-year period was not substantially lower with tube placement than with medical management.

Malignant otitis externa (MOE) is a rare, potentially life-threatening disease. It involves inflammation of the external auditory canal with concomitant osteomyelitis of the temporal bone, usually with evidence of Pseudomonas aeruginosa . The patient population is often immunocompromised, mostly due to inadequately treated type 2 diabetes mellitus or the use of immunosuppressants. Erosion of the temporal bone is common and can lead to complications such as peripheral facial nerve paralysis, meningitis, and/or cochlear and vestibular damage. The treatment of choice is usually several weeks of antibiogram-controlled intravenous antimicrobial therapy and possibly surgical treatment. Furthermore, if available, optimization of antidiabetic therapy is essential. A retrospective, descriptive, single-center study was performed to characterize consecutive real-life patients with MOE at the University Hospital Munich, Ludwig-Maximilians University, Germany. Thirteen patients with MOE were included in this study. Patient data concerning age, sex, comorbidities, pathogen spectrum, radiological imaging, antibiotic and surgical treatment and other variables were analyzed. In this study, we present a detailed description of a cohort of patients with MOE and propose a therapeutic algorithm that focuses on a combination of antibiotic therapy and surgical debridement of the affected tissue.

Acute otitis media in children accounts for 20 million office visits per year in the United States, and 18 percent of ambulatory care visits among preschool children. 1 , 2 Impaired hearing and delayed speech development are the most frequent long-term effects of recurrent episodes of otitis. 3 , 4 The economic effect of acute otitis media also indicates that prevention is needed. The estimated annual cost associated with otitis is $138 million in Finland (population, 5 million) 5 and $2 billion to $5.3 billion in the United States. 6 – 8 Streptococcus pneumoniae is the most commonly reported bacterial cause of acute otitis media, accounting for . . .