Efficacy, tolerability, and parent reported outcomes for cefdinir vs. high-dose amoxicillin/clavulanate oral suspension for acute otitis media in young children

ABSTRACT Infants and young children, especially those in day care, are at risk for recurrent or persistent acute otitis media (AOM). There are no data on oral alternatives to high-dose amoxicillin-clavulanate for treating AOM in these high-risk patients. In this double-blind, double-dummy multicenter clinical trial, we compared a novel, high-dose azithromycin regimen with high-dose amoxicillin-clavulanate for treatment of children with recurrent or persistent AOM. Three hundred four children were randomized; 300 received either high-dose azithromycin (20 mg/kg of body weight once a day for 3 days) or high-dose amoxicillin-clavulanate (90 mg/kg divided twice a day for 10 days). Tympanocentesis was performed at baseline; clinical response was assessed at day 12 to 16 and day 28 to 32. Two-thirds of patients were aged ≤2 years. A history of recurrent, persistent, or recurrent plus persistent AOM was noted in 67, 18, and 14% of patients, respectively. Pathogens were isolated from 163 of 296 intent-to-treat patients (55%). At day 12 to 16, clinical success rates for azithromycin and amoxicillin-clavulanate were comparable for all patients (86 versus 84%, respectively) and for children aged ≤2 years (85 versus 79%, respectively). At day 28 to 32, clinical success rates for azithromycin were superior to those for amoxicillin-clavulanate for all patients (72 versus 61%, respectively; P = 0.047) and for those aged ≤2 years (68 versus 51%, respectively; P = 0.017). Per-pathogen clinical efficacy against Streptococcus pneumoniae and Haemophilus influenzae was comparable between the two regimens. The rates of treatment-related adverse events for azithromycin and amoxicillin-clavulanate were 32 and 42%, respectively (P = 0.095). Corresponding compliance rates were 99 and 93%, respectively (P = 0.018). These data demonstrate the efficacy and safety of high-dose azithromycin for treating recurrent or persistent AOM.

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2707. Non 13-Valent Pneumococcal Conjugate Vaccine Serotypes Predominate as Causes of Pneumococcal Otitis Media in Children

Open Forum Infectious Diseases ◽

10.1093/ofid/ofz360.2384 ◽

2019 ◽

Vol 6 (Supplement_2) ◽

pp. S952-S952

Author(s):

Kristina G Hulten ◽

William J Barson ◽

P Ling Lin ◽

John S Bradley ◽

Timothy R Peters ◽

...

Keyword(s):

Otitis Media ◽

Conjugate Vaccine ◽

Pneumococcal Conjugate Vaccine ◽

Standard Dose ◽

Acute Otitis Media ◽

High Dose ◽

Vaccine Serotypes ◽

Pediatr Infect ◽

Susceptibility Data ◽

Amoxicillin Clavulanate

Abstract Background Pneumococcal acute otitis media (AOM) in children due to vaccine-related serotypes (ST) has declined after the introduction of the 13-valent pneumococcal conjugate vaccine (PCV13), although some serotypes, such has 3, 19A and 19F have persisted. Among non-vaccine serotypes, 35B has been shown to contribute substantially to both OM and invasive infections. This study describes the current epidemiology of pneumococcal OM isolates obtained from the U S Pediatric Multicenter Pneumococcal Surveillance Group (USPMPSG). Methods From the USPMPSG database, we collected data from patients <18 years of age with pneumococcal OM isolates from 2014 to 2018. Analysis included demographics, immunization status, antimicrobial susceptibility data and serotype. Statistical comparisons included Fisher’s exact and Wilcoxon rank-sum tests. Results A total of 494 patients with isolates were identified within the time period from 5 children’s hospitals. Median age was 1.7 years (range 0–17.6) and 299 (60.5%) were male; 176 (35.7%) had an underlying condition. Thirty-two patients had received no dose of either PCV7 or PCV13. Thirty-five serotypes were identified (3 isolates were non-typeable), of which 6 serotypes [35B (16.8%), 3 (9.5%), 15A (7.9%), 15B (7.9%), 23B (7.9%) and 21 (6.1%)] caused more than half of the total OM infections (figure). Ninety (18.2%) isolates were of PCV13 serotypes. Twenty-five of 476 (5.3%) isolates had a penicillin MIC>2 µg/mL. These were of serotypes 11A, 15A/C, 19A/F, 35B and NT; 10/455 (2.2%) isolates had ceftriaxone MIC>1 µg/mL and were of ST 3, 15A, 19A/F and 35B. Conclusion Most pneumococcal OM were caused by non-PCV13 serotypes. Serotype 35B remained the most common serotype among pneumococcal isolates recovered from ear drainage or middle ear cultures. The low proportion of penicillin-resistant isolates along with the increasing proportion of AOM cases being due to non-pneumococcal isolates supports the consideration to switch routine antibiotic treatment for AOM to standard dose amoxicillin-clavulanate from high dose amoxicillin in PCV13 immunized children (Pediatr Infect Dis J 2018;37:1255–1257). Disclosures All authors: No reported disclosures.

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Therapeutics for acute otitis media

Journal of Korean Medical Association ◽

10.5124/jkma.2021.64.9.624 ◽

2021 ◽

Vol 64 (9) ◽

pp. 624-630

Author(s):

Junghun Kown ◽

Juyong Chung

Keyword(s):

Otitis Media ◽

Middle Ear ◽

Acute Otitis Media ◽

Signs And Symptoms ◽

Acute Onset ◽

High Dose ◽

Common Infectious Disease ◽

Amoxicillin Clavulanate ◽

Primary Care Clinicians

Background: Acute otitis media (AOM) is diagnosed in patients with acute onset of signs and symptoms of inflammation in the middle ear, accompanied by middle ear effusion. AOM is a common infectious disease in children, and its diagnosis and treatment can have significant impacts on the health of children.Current Concepts: The evidence-based clinical practice guidelines in Korea and other countries provide recommendations to primary care clinicians regarding the management of children with AOM. The treatment strategy for AOM depends on the patient’s age, severity of symptoms, the presence of otorrhea, and the laterality.Discussion and Conclusion: For children aged from 6-months to 2-years with unilateral non-severe AOM and children aged 2 years or older with unilateral or bilateral non-severe AOM, the published guidelines provide the option of observation rather than immediate treatment with antibiotics. High-dose amoxicillin (80 to 90 mg a day) is the firstline antibiotic for treating AOM in patients without penicillin allergies. Children in whom symptoms persist after 48 to 72 hours of antibiotic treatment should be re-examined and amoxicillin/clavulanate should be used as second-line antibiotics. Careful follow-up is required to identify the complications and sequelae of AOM, and to determine the optimum treatment.

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In reference to: amoxicillin-clavulanate improves symptoms, reduces treatment failure in select children with acute otitis media and increases risk of diarrhoea

Evidence-Based Medicine ◽

10.1136/ebmed-2011-100452 ◽

2012 ◽

Vol 18 (2) ◽

pp. 79-79 ◽

Cited By ~ 1

Author(s):

Alejandro Hoberman ◽

Jack L Paradise

Keyword(s):

Treatment Failure ◽

Otitis Media ◽

Acute Otitis Media ◽

Amoxicillin Clavulanate

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Amoxicillin treatment increases rate of late recurrence of acute otitis media in young children

The Journal of Pediatrics ◽

10.1016/j.jpeds.2009.09.057 ◽

2010 ◽

Vol 156 (1) ◽

pp. 163

Author(s):

Petri S. Mattila

Keyword(s):

Young Children ◽

Otitis Media ◽

Acute Otitis Media ◽

Late Recurrence

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Comparison of Cefpodoxime Proxetil and Cefixime in the Treatment of Acute Otitis Media in Infants and Children

PEDIATRICS ◽

10.1542/peds.94.6.847 ◽

1994 ◽

Vol 94 (6) ◽

pp. 847-852

Author(s):

Basim I. Asmar ◽

Adnan S. Dajani ◽

Mark A. Del Beccaro ◽

Paul M. Mendelman ◽

Keyword(s):

Otitis Media ◽

Acute Otitis Media ◽

Drug Efficacy ◽

Oral Suspension ◽

Suppurative Otitis Media ◽

Once Daily ◽

Cefpodoxime Proxetil ◽

Long Term Follow Up ◽

Cure Rates

Objective. To compare the use of once-a-day cefpodoxime proxetil to once-a-day cefixime in the treatment of acute suppurative otitis media. Design. Randomized, multicenter, investigator-blinded. Setting. Outpatient. Patients. A total of 368 patients (age 2 months to 17 years) were randomized to receive either cefpodoxime or cefixime in a 2:1 ratio (245 cefpodoxime, 123 cefixime); 236 patients (155 cefpodoxime, 81 cefixime) were evaluable for drug efficacy. Interventions. Patients received either cefpodoxime proxetil oral suspension (10 mg/kg/day, once daily for 10 days) or cefixime oral suspension (8 mg/kg/day, once daily for 10 days). Main outcome measures. Clinical evaluations were performed before treatment (study day 1), at an interim visit (study day 3 through 6), at the end of therapy (study day 12 through 15), and at final follow-up (study day 25 through 38). Microbiologic evaluations were performed at enrollment and whenever appropriate thereafter. Results. End-of-therapy clinical cure rates in evaluable patients were 56% for the cefpodoxime group and 54% for the cefixime group. Clinical improvement rates were 27% for both groups. Clinical response rates were not significantly different between treatment groups (P = .541; 95% confidence interval = -8.1%, 15.2%). At long-term follow-up, 17% of patients in the cefpodoxime group and 20% in the cefixime group had a recurrence of infection. Drug-related adverse events (eg, diarrhea, diaper rash, vomiting, rash) occurred in 23.3% of cefpodoxime-treated patients and 17.9% of cefixime-treated patients (P = .282). Conclusions. These findings suggest that cefpo-doxime proxetil administered once daily is as effective and safe as cefixime given once daily in the treatment of acute suppurative otitis media in pediatric patients.

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