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CANADIAN ID 97-03
PAEDIATRIC
SOCIETY
CLINICAL
PRACTICE
GUIDELINE Antibiotic management of
acute otitis media
O titis media is the most common childhood infection for which antibiotics are prescribed.
Nonetheless, there are a number of important questions about the optimal management
of acute otitis media (AOM), and opinion is divided within the medical community on a range of
fundamental issues. The purpose of this statement is to address several controversial ques-
tions regarding antimicrobial management of AOM and to present a consensus opinion on
each. It must be emphasised that much remains to be learned about management of this com-
mon childhood problem and that ongoing research may mandate revision of these opinions in
the near future; these recommendations must, therefore, be considered provisional and de-
pendent upon the current state of the art.
Evaluation of studies to determine whether antibiotic therapy influences the outcome of
AOM has been difficult to interpret because of the high spontaneous recovery rate in children
with the disease (1). Furthermore, many of the studies have been designed to try to demon-
strate whether new antimicrobial agents are as good as conventional therapy, but they have em-
ployed small sample sizes. For a disease with a high spontaneous rate of improvement, only
studies with a very large sample size provide enough power to demonstrate whether two differ-
ent interventions are indeed truly comparable. Thus, the published literature provides little
guidance regarding superiority of one antimicrobial agent over another.
For the purpose of this paper, AOM is defined as the sudden onset of inflammation of the
middle ear associated with an effusion and one or more of the following: pain, fever and irri-
tability. The diagnosis must be established by careful examination with pneumatic otoscopy.

SHOULD ANTIBIOTICS BE USED TO TREAT AOM?

Antimicrobial therapy is one of the cornerstones in the management of AOM but some stud-
ies have suggested that its routine use is not indicated (2-4). Because the majority of cases of
AOM resolve spontaneously (1), it might appear that antimicrobial therapy is not necessary.
Nonetheless, in the preantibiotic era, complications of AOM such as mastoiditis were far more
common than they are today (5,6); this difference may be due to the current routine use of anti-
biotics. A recent meta-analysis of 5400 children with AOM indicated that antimicrobial therapy
enhanced the primary control by 13.7% despite a spontaneous recovery in 81% of cases (1).
Because it is probably not possible to determine a priori which cases of AOM will result in sup-
purative complications, it is likewise not possible to determine which cases require antimicro-
bial therapy and which will resolve spontaneously. Therefore, it appears prudent to consider all
cases of AOM candidates for antimicrobial therapy in order to minimize the likelihood of com-
plications. This is clearly an area where more research is required to identify which patients
with AOM require therapy and which would improve spontaneously without it. Some experts
recommend watchful waiting for 48 to 72 h before initiating antibiotic therapy (4). This ap-
proach may be feasible in children over two years of age if good follow-up can be assured; there-
fore, decisions about whether to withhold antibiotics therapy initially must be made on a
patient-by-patient basis.

WHICH ANTIBIOTIC IS THE DRUG OF CHOICE FOR AOM?

Bacteria cause the majority of cases of AOM, and the most frequent etiological agents are
Streptococcus pneumoniae, nontypeable Haemophilus influenzae, Moraxella catarrhalis,
group A streptococcus and Staphylococcus aureus. Viruses continue to cause a substantial mi-
nority of cases (7), and antibiotic therapy would not be expected to affect the outcome. With the

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CPS Clinical Practice Guideline: ID 97-03

TABLE 1: Cost of a 10-day course of antibiotics for therapy of a 10 kg child with otitis media
Cost by location ($)*
Antibiotic Dose Frequency Vancouver, BC Quebec City, QC
Amoxicillin 125 mg tid 10.13 11.99
Amoxicillin-clavulanate 125 mg tid 23.25 27.25
Trimethoprim-sulfamethoxazole 5 cc bid 9.07 9.43
Erythromycin-sulfisoxazole 2.5 cc qid 19.31 25.72
Cefaclor suspension 125 mg tid 25.32 30.53
Cefixime 100 mg od 25.59 25.07
Cefuroxime axetil 125 or 250 mg bid 23.46 23.45
Cefprozil suspension 125 mg bid 22.37 22.30
Clarithromycin suspension 75 mg bid 33.70 24.37
Azithromycin day 1: 100 mg od 24.42 23.85
days 2-5: 50 mg
*Total cost to patient, including dispensing fee; prices obtained from private pharmacies in Vancouver and in Quebec City; A five-day course of azithromycin is recommended
because of its unique pharmacokinetics

increasing prevalence of beta-lactamase-producing
(penicillin-resistant) strains of H influenzae and M catar-
rhalis, alarms have been sounded about the wisdom of
routinely using aminopenicillins (such as amoxicillin) as
the standard first-line antimicrobial for uncomplicated
AOM. Despite theoretical concerns about the diminishing
usefulness of amoxicillin, it continues to be as effective as
any other oral antimicrobial agent for childhood AOM. In
fact, it works as well as extended spectrum, penicil-
linase-resistant oral agents for otitis media caused by ei-
ther penicillin-susceptible or -resistant bacteria (1). Most
comparative trials of antimicrobial therapy in AOM have
failed to demonstrate a difference in effectiveness be-
tween amoxicillin and any other agent. Furthermore, the
newer, broader spectrum, penicillinase-stable antimicro-
bial agents are substantially more expensive than amox-
icillin (Table 1), and their use may be associated with
relatively high rates of side effects and may increase the
pressure for selection of multiply antibiotic-resistant
strains of bacteria. Therefore, because of its excellent
track record (for infections due to penicillin-susceptible
and -resistant bacteria), low cost, safety and acceptability
to patients, amoxicillin remains the drug of choice for un-
complicated AOM.
WHAT IS A REASONABLE EXPECTATION FOR
RESPONSE TO THERAPY?
One can reasonably expect that the symptoms of AOM
(fever, irritability and ear pain) will resolve within 72 h of
initiation of antimicrobial therapy. If, after this length of
therapy symptoms persist, the child should be re-
evaluated to determine if the infection is persisting or has
evolved into one of the suppurative complications. If the
patient has complied with the prescribed therapy and the
symptoms, such as pain and fever, have persisted, a
change in antimicrobial regimen is appropriate. The dif-
ferent second-line agents from which to choose are listed
in Table 1. Whereas the symptoms of AOM listed above
should resolve promptly with antimicrobial therapy, the
middle ear effusion may persist for up to three months
despite bacteriological cure (8). Therefore, persistence of
middle ear fluid after a full course of antibiotic therapy of
AOM is not an indication for continued therapy or for in-
stitution of treatment with a second-line drug.
WHAT IS THE OPTIMAL DURATION OF ORAL
THERAPY OF AOM?
Because there is such a high spontaneous cure rate for
AOM, it has been difficult to determine the optimum du-
ration of antimicrobial therapy. Furthermore, without ap-
propriate bacteriological assessment (9) and follow-up
(with repeated tympanocentesis) response to therapy is
impossible to gauge. Therefore, studies with sufficient
power and appropriate design to determine the efficacy of
short-course therapy have been difficult to perform.
Studies that purport to demonstrate equivalence of five-
and 10-day duration (10,11) may simply have indicated
that the majority of patients will improve whether they are
treated or not. Until it can be clearly demonstrated that a
short course of therapy is effective, patients should be
treated for 10 days. The only exception is azithromycin,
for which a five-day course is recommended because of
its unique pharmacokinetics.
WHAT IS THE ROLE OF PARENTERAL THERAPY
FOR AOM?
With the advent of extended spectrum cephalosporins
with prolonged half-life (eg, ceftriaxone), the option of
parenteral therapy with a single dose has become feasi-
ble. There is, at present, little published evidence that
parenteral therapy provides any advantage to the conven-
tional 10-day oral therapy. Furthermore, the use of such
broad-spectrum agents may hasten the emergence of
antibiotic-resistant organisms. Except in extraordinary
situations, parenteral therapy should not be employed for
simple uncomplicated childhood AOM. If a child appears

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to be too ill to comply with standard oral therapy, a diag-
nosis other than AOM should be entertained and admis-
sion to hospital should be considered.
WHAT IS THE OPTIMAL ANTIMICROBIAL
MANAGEMENT OF TREATMENT FAILURES?
As stated above, the symptoms of AOM (fever, irritabil-
ity and otalgia) should resolve within 72 h of initiating
antimicrobial therapy. Failure of symptomatic response
to appropriate therapy (with evidence of compliance) con-
stitutes a treatment failure. The optimal management of
such patients is controversial and various approaches
have been advocated (12). A tympanocentesis should be
considered for both therapeutic (relief of pressure and
pain) and for diagnostic (recovery of the etiologic agent)
purposes. If a tympanocentesis is not practical, consid-
eration should be given to adding amoxicillin-clavulanate
or selecting one of the alternative agents from Table 1. If a
tympanocentesis is performed, the antibiotic choice
should ultimately be guided by the etiological agent and
antimicrobial susceptibility.
WHAT IS THE BEST THERAPY FOR AOM IN PATIENTS
ALLERGIC TO PENICILLIN?
In patients with documented allergy to penicillin, an al-
ternative to amoxicillin is required. Although there is a
risk of cross-reaction to other beta-lactam agents, this oc-
curs rarely and therapy with a cephalosporin is generally
safe. Agents from which to choose and their costs are
listed in Table 1. The choice should be guided by various
considerations including cost, frequency of adverse side-
effects and patient tolerability. A reasonable choice is ei-
ther trimethoprim/sulfamethoxazole or erythromycin/sul-
fisoxazole.

REFERENCES
1. Rosenfeld RM, Vertrees JE, Carr J, et al. Clinical efficacy of
antimicrobial drugs for acute otitis media: Metaanalysis of 5400
children from thirty-three randomized trials. J Pediatr
1994;124:355-67.
2. van Buchem FL, Dunk JH, vant Hof MA. Therapy of acute otitis
media: Myringotomy, antibiotics, or neither? A double-blind study in
children. Lancet 1981;ii:883-7.
3. Mygind N, Meistrup-Larsen KI, Thomsen J, et al. Penicillin in acute
otitis media: A double-blind placebo-controlled trial. Clin
Otolaryngol 1981;6:5-13.
4. van Buchem FL, Peeters MF, vant Hof MA. Acute otitis media:
A new treatment strategy. Br Med J 1985;290:1033-7.
5. Gold R. Consensus recommendations for the management of otitis
media. Can J Diagnosis 1989;6:67-76.
6. Berman S. Otitis media in children. N Engl J Med 1995;332:1560-5.
7. Carroll K, Reimer L. Microbiology and laboratory diagnosis of
upper respiratory tract infections. Clin Infect Dis
1996;23:442-8.
8. Klein JO. Otitis media. Clin Infect Dis 1994;19:823-33.
9. Gooch WM, Blair E, Puopolo A, et al. Effectiveness of five days of
therapy with cefuroxime axetil suspension for treatment of acute
otitis media. Pediatr Infect Dis J 1996;15:157-64.
10. Hendrickse WA, Kusmiesz H, Shelton S, Nelson JD. Five vs.
ten days of therapy for acute otitis media. Pediatr Infect Dis J
1988;7:14-23.
11. Chaput de Saintonge DM, Levine DF, Savage IT, et al. Trial of
three-day and ten-day courses of amoxycillin in otitis media.
Br Med J 1982;284:1078-81.
12. Klein JO, Bluestone CD. Management of otitis media in the era of
managed care. Adv Pediatr Infect Dis 1996;12:351-86.

INFECTIOUS DISEASES AND IMMUNIZATION COMMITTEE

Members: Drs Gilles Delage, Directeur scientifique, Laboratoire de sant publique du Qubec, Ste-Anne-de-Bellevue, Qubec (chair); Franois
Boucher, Dpartement de pdiatrie, Centre Hospitalier Universitaire de Qubec, Pavillon CHUL, Qubec, Qubec; Joanne Embree, Winnipeg,
Manitoba; Elizabeth Ford-Jones, Division of Infectious Diseases, The Hospital for Sick Children, Toronto, Ontario; David Speert, Head, Division of
Infectious and Immunological Diseases, University of British Columbia, Vancouver, British Columbia (principal author); Ben Tan, Division of Infectious
Diseases, Royal University Hopsital, University of Saskatchewan, Saskatoon, Saskatchewan
Consultants: Drs Noni MacDonald, Division of Infectious Diseases, Childrens Hopsital of Eastern Ontario, Ottawa, Ontario; Victor Marchessault,
Cumberland, Ontario
Liaisons: Drs Neal Halsey, Johns Hopkins University, Baltimore, Maryland (American Academy of Pediatrics); Susan King, Division of Infectious Diseases,
The Hospital for Sick Children, Toronto, Ontario (Canadian Paediatric AIDS Research Group); David Scheifele, Division of Infectious Diseases, BCs
Childrens Hospital, Vancouver, British Columbia (Centre for Vaccine Evaluation); Susan Tamblyn, Perth District Health Unit, Stratford, Ontario (Public
Health); John Waters, Provincial Health Officer, Alberta Health, Edmonton, Alberta (Epidemiology)

The recommendations in this Clinical Practice Guideline do not indicate an exclusive course of treatment or procedure to be
followed. Variations, taking into account individual circumstances, may be appropriate.

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