Novel antimicrobial shows promise for children with AOM

Investigators examined the efficacy and safety of a new formulation of amoxicillin-clavulanate to treat acute otitis media (AOM) in children | Contemporary Pediatrics

Children with acute otitis media (AOM) are routinely and successfully treated with antimicrobials, with data showing that the combination of amoxicillin-clavulanate (A/C) to treat AOM in children aged younger than 3 years is associated with more favorable outcomes than placebo.

Although effective, antimicrobial treatment is associated with the unwanted adverse effect of diarrhea that studies show can affect between 25% to 48% of children. Children who experience this common adverse effect may have to wait to return to daycare until it resolves, which in turn may delay parents’ return to work.

Finding a way to maintain the efficacy of antimicrobial treatment while reducing this unwanted adverse effect was the objective of recent study by Hoberman and colleagues. Based on evidence showing that the clavulanate component of the routinely administered antimicrobial treatment is responsible for diarrhea, the investigators examined the efficacy and safety of a novel formulation of the antimicrobial in which the total effective dose of clavulanate is reduced.

The open-label study found that reducing the total dose of clavulanate was associated with the desired reduction in diarrhea and diaper dermatitis without appearing to compromise efficacy; however, the lead author of the study, Alejandro Hoberman, MD, chief, Division of General Academic Pediatrics, professor of Pediatrics and Clinical and Translational Science, Children’s Hospital of Pittsburgh of UPMC, Pennsylvania, emphasized that these findings will have to be properly studied in a larger clinical trial.

Why are ototopical aminoglycosides still first-line therapy for chronic suppurative otitis media?

This systematic review aimed to establish that quinolones are as effective as aminoglycosides when used to treat chronic suppurative otitis media | The Journal of Laryngology & Otology


The review included good quality, randomised, controlled trials on human subjects, published in English, that compared topical aminoglycosides with topical quinolones for the treatment of chronic suppurative otitis media.

Nine trials met the criteria. Two studies showed a higher clinical cure rate in the quinolone group (93 per cent vs 71 per cent, p = 0.04, and 76 per cent vs 52 per cent, p = 0.009). Four studies showed no statistically significant difference in clinical outcome. A significant difference in microbiological clearance in favour of quinolones was shown in two studies (88 per cent vs 30 per cent, p < 0.001, and 88 per cent vs 30 per cent, p < 0.001).

Topical quinolones do not carry the same risk of ototoxicity as aminoglycosides. Furthermore, they are equal or more effective in treating chronic suppurative otitis media and when used as prophylaxis post-myringotomy. Topical quinolones should be considered a first-line treatment for these patients.

Full reference: Harris, A.S. et al. (2017) Why are ototopical aminoglycosides still first-line therapy for chronic suppurative otitis media? A systematic review and discussion of aminoglycosides versus quinolones. The Journal of Laryngology & Otology. Vol. 130, (no. 01) pp. 2-7

Shortened Antimicrobial Treatment for Acute Otitis Media

Vincen, D.R. (2017) New England Journal of Medicine. 376:e24


Hoberman et al. (Dec. 22 issue)1 conducted a well-designed trial that showed that a 10-day course of amoxicillin–clavulanate was superior to a 5-day regimen in children 6 to 23 months of age with acute otitis media. The investigators explain that they chose to study amoxicillin–clavulanate because it “is currently the most efficacious oral antimicrobial agent for the treatment of acute otitis media.”

But efficacy is not the only variable influencing such a treatment decision. High-dose amoxicillin is effective against common bacterial pathogens. It also has a favorable safety profile, a taste acceptable to children, a relatively low cost, and a narrower microbiologic spectrum than amoxicillin–clavulanate. It is this collective argument that professional societies around the world give for their recommendation of amoxicillin as the first-line agent for the treatment of acute otitis media in children.

Is it valid to infer that because a 10-day course of amoxicillin–clavulanate outperformed a 5-day course that similar results would follow if the antimicrobial agent under investigation were high-dose amoxicillin instead? If this inference is weak, why then did the investigators not study amoxicillin directly?

Read the full letter to the editor here

The original research article abstract is available here

Pre- and post-admission antibiotic treatment in paediatric acute mastoiditis

Carmel, E. et al. (2017) The Journal of Laryngology & Otology. 131(S1) pp. S12-S17

Aim: To evaluate the effect of pre- and post-admission antibiotic treatment in paediatric acute mastoiditis.

Conclusion: Paediatric acute mastoiditis patients treated with antibiotic therapy prior to admission are at higher risk for complication development. The advised time period for oral antibiotic therapy following hospital discharge remains as 10 days in all cases of uncomplicated acute mastoiditis.

Read the abstract here

Shortened Antimicrobial Treatment for Acute Otitis Media in Young Children

Hoberman, A. et al. 92016) New England Journal of Medicine. 375:2446-2456


Background: Limiting the duration of antimicrobial treatment constitutes a potential strategy to reduce the risk of antimicrobial resistance among children with acute otitis media.

Conclusions: Among children 6 to 23 months of age with acute otitis media, reduced-duration antimicrobial treatment resulted in less favorable outcomes than standard-duration treatment; in addition, neither the rate of adverse events nor the rate of emergence of antimicrobial resistance was lower with the shorter regimen.

Read the full abstract here

Close Follow-up in Children With Acute Otitis Media Initially Managed Without Antimicrobials

Uitti, J. et al. (2016) JAMA Pediatrics. 170 (11) pp. 1107-1108


According to several national guidelines, close follow-up is required if initial observation without antimicrobial agents is chosen for the management of acute otitis media (AOM) in children.

The aim of this study was to examine whether close follow-up with reexamination is needed for children with AOM initially managed without antimicrobial agents who have symptomatic improvement during the first week after diagnosis, as assessed by their parents.

Read the full article here