A team of physicians describe a baby’s symptoms from a recent case, and proffer two treatment scenarios, the options and the supporting evidence for both being outlined by the experts from Boston Children’s Hospital, US.
Their vignette was published in the New England Journal of Medicine.
A previously healthy 13-month-old girl is taken to the paediatrician after having rhinorrhoea and a mild cough for a few days, and fever (maximum temperature 38°C) and tugging of the left ear for one day.
She has had one previous ear infection, which was treated with amoxicillin; she has not had other clinically significant medical problems apart from intermittent viral infections. She has never been hospitalised.
On physical examination, fluid is visible in the left ear behind the tympanic membrane, which is bulging slightly. The light reflex and landmarks are distorted. The right tympanic membrane appears to be within normal limits.
Both conjunctivae are mildly injected but not purulent. Her mucous membranes are moist, and capillary refill is appropriate.
However, her parents report that her intake of milk and solids has decreased slightly in the past few days with this illness.
You diagnose unilateral acute otitis media in this patient.
Her parents, who say they understand that over-prescription of antibiotics can result in resistant “bugs”, stress that they want the best for their child and ask for advice.
You must decide whether you should recommend a watchful waiting approach or prescribe antibiotics now.
Treatment options
Which one of the following approaches would be best, based on the literature, your own experience, published guidelines, and other information?
1. Watch and wait with close follow-up.
2. Prescribe antibiotics now.
Option 1
Watch and wait with close follow-up
Mary Anne Jackson, MD – Section of Infectious Disease, Department of Paediatrics, Children’s Mercy Kansas City, and the University of Missouri-Kansas City School of Medicine.
This immune-competent 13-month-old girl has cough, coryza, and conjunctivitis, signs of a viral upper respiratory infection – the most common trigger for acute otitis media. Adenovirus is the most likely cause, but influenza virus, enterovirus, or rhinovirus could also be the viral culprit.
Measles may be considered given recent outbreaks but is unlikely if she has received the measles/mumps/rubella vaccine. This is not a case of conjunctivitis-otitis syndrome, as that syndrome causes purulent conjunctivitis. Although the patient will recover from her upper respiratory infection, she also has non-severe unilateral acute otitis media.
So the question becomes whether to treat immediately with antibiotics or recommend a watchful waiting approach.
Immediate antibiotics for acute otitis media are recommended for patients younger than six months, those six months of age or older who have acute otitis media with severe symptoms (temperature of ≥39°C, moderate-to-severe otalgia, or otalgia that has lasted longer than 48 hours), children under two with acute otitis media in both ears or with disease in one ear and severe symptoms, or any child with otorrhoea not associated with otitis externa.
The patient in the vignette is older than six months, meets the criteria for non-severe acute otitis media, and is eligible for watchful waiting – provided her previous episode of acute otitis media was more than 30 days ago and she does not have a contraindication such as cleft palate, cochlear implants, or Down’s syndrome.
Physicians opting for watchful waiting, after joint decision-making with the parents, can write a prescription for antibiotics that they instruct parents to fill if symptoms worsen or do not resolve in 72 hours.
If the child’s symptoms resolve with otalgia analgesics and the child does not require antibiotics, side effects and colonisation with resistant pathogens are avoided, without an increase in the risk of recurrence of acute otitis media.
Many cases of acute otitis media will resolve without antibiotics. Of the classic otopathogens that cause acute otitis media, Moraxella catarrhalis and nontypable Haemophilus influenzae are associated with cases that tend to be less severe than those associated with Streptococcus pneumoniae acute otitis media.
According to data from the early 1990s, M. catarrhalis infection tends to resolve without antibiotics in at least 75% of cases, and nontypable H. influenzae infection resolves without antibiotics in about 50% of cases.
Although S. pneumoniae acute otitis media is unlikely to resolve without antibiotics and cases are associated with higher fevers and greater redness and bulging of the tympanic membrane, cases of S. pneumoniae acute otitis media (and the incidence of acute otitis media overall) have substantially declined since the introduction of pneumococcal conjugate vaccines in 2000.
Overuse of antibiotics drives bacterial resistance and is associated with high costs, a risk of rashes and diarrhoea, and (less commonly) severe allergic reactions or Clostridioides difficile infection. More than 10m antibiotic prescriptions, many for inappropriately broad-spectrum agents, are provided each year for acute otitis media.
In one study at a Denver health centre, non-first-line antibiotics for acute otitis media were prescribed for nearly 20% of the children, and 77% received prescriptions that exceeded recommendations for duration of therapy.
A Cochrane review concluded that for every 14 children treated with antibiotics, one will have vomiting, diarrhoea, or rash.
When rash occurs in the context of antibiotics, it is typically related to viral illness, but if patients are categorised as being allergic to antibiotics, broader-spectrum antibiotics are often prescribed in future encounters.
Whether a patient is brought to a trusted paediatric provider or an urgent care facility, many parents will voice concerns regarding antibiotic resistance or side effects and will be receptive to watchful waiting. When indicated, watchful waiting can avoid many potential harms, with few downsides to the delay of 48 to 72 hours if treatment ultimately needs to be initiated.
Option 2
Prescribe antibiotics now
David Tunkel, MD – From the Department of Otolaryngology: Head and Neck Surgery, and the Department of Paediatric Otolaryngology, Johns Hopkins Children’s Centre, Johns Hopkins University School of Medicine.
Acute otitis media is the most common condition leading to antibiotic use among children in the US, but antibiotics are not indicated for every case. The 2013 American Academy of Paediatrics (AAP) guidelines on acute otitis media emphasised accurate otoscopy for diagnosis and provided guidance for observation as compared with immediate antibiotic therapy.
Even so, the effect of guidelines on reduction in antibiotic prescription has been disappointing.
For example, a patient education page in JAMA Paediatrics in 2020 noted that children “typically need an antibiotic to treat the infection”.
Treatment of acute otitis media with antibiotics is recommended for all children under six-months-old, for children between six months and two years with disease in both ears or with disease in one ear and severe symptoms, or for any child with acute otitis media and otorrhoea.
Antibiotic therapy for children six months to two years of age with milder symptoms is an option based on shared decision-making with informed caregivers. The young child in the vignette is in this category, and the advantages of antibiotic therapy should be discussed as part of this shared decision-making.
This child has symptoms that could be considered moderate, with a temperature of 38°C, otalgia, and concomitant symptoms of upper respiratory infection.
The presence of middle-ear fluid with bulging makes the diagnosis of acute otitis media likely to be correct. Her conjunctival injection raises the possibility of conjunctivitis–otitis syndrome due to nontypable H. influenzae, which is best treated with beta-lactamase stable antibiotics and may be associated with treatment failure requiring ceftriaxone.
Antibiotic therapy should also be recommended for children whose access to follow-up care is uncertain. A randomised, controlled trial by Hoberman et al. showed that symptom scores were lower, and there were fewer treatment failures, among children six to 23 months old who were treated with amoxicillin–clavulanate than among those who received placebo (16% vs. 51% at or before the visit on day 10 to 12).
Another randomised, controlled trial, by Tähtinen et al, showed that there were fewer treatment failures among children six to 35 months old who were treated with amoxicillin–clavulanate than among those who received placebo (18.6% vs. 44.9%).
A Cochrane systematic review of antibiotics for acute otitis media showed that although antibiotics did not reduce pain in the first 24 hours, they produced a modest reduction in pain at two to three days (risk ratio, 0.70; 95% confidence interval [CI], 0.57 to 0.86) and at 10 to 12 days (risk ratio, 0.33; 95% CI, 0.17 to 0.66), but with a high number needed to treat to see benefit (number needed to treat for an additional beneficial outcome, 20 for reduced pain at two to two days and seven for reduced pain at 10 to 12 days).
Antibiotic therapy was associated with slightly more-frequent diarrhoea and vomiting, with a number needed to treat for an additional harmful outcome of 14.7
In summary, I would expect a modest reduction in symptoms and a lower likelihood of treatment failure with antibiotic therapy. The shared decision-making discussion should inform parents about antibiotic stewardship, the modest benefits of antibiotics, and the possibility of drug side effects.
Clinicians should then incorporate and reconcile the preferences of the parents with their own recommendations. Regardless of whether the decision is for antibiotics or watchful waiting, clinicians should treat pain and should establish the means for follow-up if symptoms warrant a change in treatment.
Study details
Watchful waiting versus antibiotics for acute otitis media in paediatric patients
Julie Barzilay, Mary Anne Jackson, and David Tunkel.
Published in the NEJM on 30 October 2024
Abstract
This case vignette of a 13-month-old girl with fever and acute otitis media in one ear is accompanied by two essays, one recommending watchful waiting with close follow-up and the other supporting prescription of antibiotics.
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