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Acute Otitis Media

Dr. Ghaleb Zughayar Consultant Pediatrician and Neonatologist.
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Objectives
Otitis Media

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Demonstrate an understanding of pathophysiology List the common pathogens Demonstrate knowledge of both the advantages and disadvantages of antibiotic therapy Demonstrate application of an appropriate treatment plan
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Definition

Acute Otitis Media (AOM)

“acute onset of symptoms, evidence of a middle ear effusion, and signs or symptoms of middle ear inflammation.” “Presence of MEE without signs or symptoms of infection, previously named: secretory, serous, or glue ear. ”
Rudolph's Pediatrics - 21st ed 2002 3

Otitis Media with effusion (OME)

Definition (continuous)
Difficult to treat AOM (20%) Recurrent AOM: three or more episodes in the previous six months or four or more in the preceding twelve months.
 Treatment

failure AOM: a lack of improvement in sign and symptoms within 48-72 hours of AB treatment .

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 CSOM: purulent otorrhea that persists for more than six weeks despite appropriate treatment for AOM. 5 . Chronic Otitis media with effusion: OME that persists beyond three months.Definition (continuous).

Most common diagnosis for an AB prescription in children.Epidemiology      31 million visits to physicians annually in U.S.000 deaths / year worldwide. Diagnosed > 5 million times a year.S. 3-5 billion $/year in U. 50. N Engl J Med 2002 347:1169-1174 6 .

Pathophysiology  Eustachian tube obstruction   Length: shorter in children Angle: 10o children vs.4 days N Eng J Med 2002 347: 169-1174. Pediatr Infect Dis J 1996 15:281-291 7 . 45o adult   Decreased immunocompetence Follows upper respiratory infection (URI)  Peak incidence 2 .

Risk factors ● Age <2 years ● Atopy ● Bottle propping ● Chronic sinusitis ● Ciliary dysfunction ● Cleft palate and craniofacial anomalies ● Child care attendance ● Down syndrome and other genetic conditions ● First episode of AOM when younger than 6 months of age ● Immunocompromising conditions Pediatr Infect Dis J 1999 18:1-9 8 .

Diagnosis: Clinical Manifestations  Specific      Non-specific    Otalgia Otorrhea Dizziness Hearing loss  Fever (50%) Vomiting/diarrhea Anorexia Irritability 9 .

or bright red color  Opacification of eardrum  Impaired visibility of ossicular landmarks  Squamous exudate  Rudolph’s Pediatrics . white.21st ed 2002 10 .Diagnosis: Clinical Findings  Otoscopic findings Bulging TM  Yellow.

2.Pathogens Bacterial  Viral          Streptococcus pneumoniae Haemophilus influenzae Moraxella catarrhalis RSV Influenzae A & B Parainfluenzae 1. &3 Rhinovirus Adenovirus Enterovirus Coronavirus 11 .

Potential Complications   Hearing loss Acute mastoiditis Rare:  Meningitis  Subdural/extradural abscess 12 .

Treatment Considerations      Allergies AOM history Spectrum of activity Local resistance pattern Recent antibiotic treatment      Age Duration Compliance Adverse drug events Cost 13 .

Treatment Considerations   Drug resistant S. pneumoniae (DRSP) incidence increasing Patients at high risk for DRSP Attending day care  < 2 years old  Antibiotic therapy in preceding 3 months  14 .

pneumoniae U. 1979-2000 30 25 20 15 10 5 0 1979 1982 1985 1988 1991 1994 1997 2000 % Nonsusceptible Intermediate Resistance High Level Resistance 15 .Penicillin Resistance of S.S.

DRSP at Children’s Hospital Boston 35 30 25 20 15 10 5 0 Intermediate Resistant 19 91 19 92 19 93 19 94 19 95 19 96 19 97 19 98 19 99 20 00 20 01 16 .

Why Focus on Pneumococcus?      Most common initial bacterial pathogen Most common isolate after failed therapy Least likely bacterial pathogen to self resolve Most likely to cause severe otitis media Most likely to cause suppurative complications of otitis (mastoiditis) Pediatr Infect Dis J 1998 17: 1084-1089 17 .

Treatment Options   AOM spontaneously resolves 40 . antihistamines. & corticosteroids < 2 yo AOM s/sx  3 days Ill-appearing patients Patients at an increased risk of DRSP N Engl J Med 2002 347: 1169-1174 18   Adjunctive therapy  Who to treat with antibiotics?     .60% Symptomatic therapy  Applied heat. analgesics. antipyretics & topical anesthetic Decongestants.

but if persists > 3 months consider retreatment  19 . bulging and opaque TM  Pain   OME does not need immediate antibiotic therapy Commonly seen with acute URI  Little or no benefit of antibiotic therapy  Persistent effusion expected for 2-3 months following therapy for AOM.Judicious Antibiotic Use  Proper diagnosis of AOM or OME before committing to antibiotic therapy  Diagnosis of AOM requires evidence of local inflammation & systemic symptoms Erythema alone is not sufficient  Thickened.

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pneumoniae 40 – 50 20 – 30 10 – 15 10 .16 35 – 40 95 20 50 90 H. 17:1058-1059 22 . influenzae M. 18:1-9 Pediatric Infect Dis J 1998. catarrhalis Pediatric Infect Dis J 1999.Amoxicillin: 1st Line Rationale Pathogen % Cases % Resistant to amoxicillin % Spontaneous resolution S.

5% (29 of 31) Dagan et al.How Effective is HD (90 mg/kg/d) Amoxicillin* Against Pneumococcus? Susceptibility Sensitive (MIC 0.06) Intermediate (MIC 0.1-1) Resistant (MIC >2) Bacterial Eradication 100% (61 of 61) 100% (21 of 21) 93. Poster 107. ICAAC 2000 *Study done w/ amox/clav but clav has no activity against pneumococcus 23 .

influenza and M.Treatment Failure   No improvement in ear pain. cattarhalis  Pediatr Infect Dis J 1999 18:1-9 24 . fever. bulging or redness after 3 days of antibiotic therapy 2nd Line Therapy DRSP  Beta-lactamase producing H. or tympanic membrane otorrhea.

868)   Reduction of otitis office visits Reduction of antibiotic prescriptions Goal: decrease number of URI    Influenza vaccine  Breast feeding Prophylaxis    3 episodes in 6 months or 4 episodes in 1 yr <6 months with >1 episode Cause of resistance in the community Pediatr Infect Dis J 2003 22:10-16. Pediatr Infect Dis J 1998 17:1084-1089 25 .Prevention  Heptavalent pneumococcal conjugate vaccine (n=37.

no improvement at 24 hr. otorrhea >14 days 26 >24 mo Symptomatic care . earache/fever >3 days.Dutch Guidelines for AOM Age < 6 mo 6-24 mo Management Antibiotic prescribed re-eval at 24 hrs Symptomatic care re-eval at 24 hours Antibiotics Always High risk. otorrhea >14 days High risk.

In Summary . . .      Antibiotic resistance is here High rates of antibiotic use in children has contributed to resistance rates Vast majority of antibiotic use in children is for AOM Minimizing unnecessary antibiotic prescribing can slow the rate of resistance First line treatment of AOM is amoxicillin 90 mg/kg/day divided TID !! 27 .

antibiotics within 3 months) 1st Line Therapy Treatment Failure (Day 3) Yes High dose (HD) amoxicillin. or cefuroxime axetil HD Augmentin®. cefuroxime axetil.Treatment High risk DRSP? (Day care. <2 yo. ceftriaxone IM x3 days. or clindamycin No HD amoxicillin 28 . HD Augmentin®.

18 (4): 341 29 . Pediatr Infect Dis J 1999 Apr.DRSP Beta-lactam Activity & Levels Dowell SF et al.

flu or M. DRSP Does NOT cover betalactamase producing H.cat Tastes excellent Considerations   Rash Diarrhea Nausea/vomiting Hypersensitivity to penicillins Capsule Chewable Tab Tablet Suspension 30  Contraindications    Dosage Forms   Dosing   SD: 40 mg/kg/day TID HD: 90 mg/kg/day TID (max 3 g/day)    .Amoxicillin   Class   Adverse Events    Penicillin Most effective PO agent vs.

Augmentin® Selection after HD Amoxicillin Failure   Addition of clavulanate No additional coverage for pneumococcus compared to amoxicillin  Augmentin ES® = 90 mg/kg/d of amoxicillin which is equivalent. cat 31 . NOT superior to HD amoxicillin for DRSP  Excellent coverage for beta lactamase positive H. flu and M.

 as well as decreases GI upset Tastes good HD 80 . 200/28.25/5 mL. flu & M.5 mg 32 Dosage forms   Dosing     . 875 mg (125 mg clavulanate) Tablet XR  1000 mg/62.5/5 mL.Amoxicillin/clavulanate (Augmentin®. 400/57/5 mL Susp ES  600 mg/42. Augmentin ES®.cat Food may enhance absorption. Augmentin XR®)   Class   Adverse Events    Penicillin Equal DRSP coverage to amoxicillin  Covers beta-lactamase producing H. 250/62.9/5 mL Tablet  250 mg.5/5 mL.90 mg/kg/day TID (except XR)(max 3g/day amox) Considerations     Nausea/vomiting Diarrhea Rash Contraindications  Hypersensitivity to penicillins Suspension & chewable tablets 125/31. 500 mg.

cat coverage  Stable against beta-lactamase activity 33 .Oral Cephalosporins: Selection after HD Amoxicillin Failure All ORAL cephalosporins are LESS ACTIVE against DRSP than amoxicillin   No benefit for DRSP after failing high dose amoxicillin Adds improved H. flu and M.

cat Requires food for absorption Tastes bad 30 mg/kg/day BID (max 1000 mg/day)  Considerations   Nausea/vomiting Diarrhea Rash  Contraindications  Hypersensitivity to cephalosporins    Dosage forms    Dosing  Suspension Tablets 34 .flu & M.Cefuroxime axetil  Class   Adverse Events    Cephalosporin (2nd generation) Decreased efficacy against DRSP Efficacious against betalactamase producing H.

BID (max 600 mg/day)  Considerations   Nausea/vomiting Diarrhea Rash  Contraindications  Hypersensitivity to cephalosporins   Dosage forms    Dosing  Suspension Tablets 35 .cat Tolerable tastebanana/strawberry 14 mg/kg/day QD .Cefdinir  Class   Adverse Events    Cephalosporin (3rd generation) Decreased efficacy against DRSP Efficacious against betalactamase producing H.flu & M.

17:1126 36 .Ceftriaxone 3rd Generation Cephalosporin  Option when PO therapy fails    High middle ear fluid levels Slightly better activity than amoxicillin No comparison trial vs. HD amoxicillin for DRSP therapy 1 dose only has ~50% eradication of intermediate resistant strains of pneumococcus 95% eradication of resistant strains Little data on fully resistant DRSP (PCN MIC>2)  Requires 3 IM doses    Lebowitz E et al Pediatr Infect Dis 1998.

Ceftriaxone  Class   Adverse Events    Cephalosporin (3rd generation) Good coverage against DRSP and beta. flu 50 mg/kg QD for 3 days IM (max 1 gram)  Considerations  Nausea/vomiting Diarrhea Rash  Contraindications  Hypersensitivity to cephalosporins  Dosing   Dosage forms  IM / IV 37 .lactamase producing M. cat & H.

Non Beta-lactam Antibiotics Activity Against DRSP Clindamycin Erythromycin Bactrim % Isolates Susceptible Pen-S Pen-I Pen-R 98% 90% 85% 96% 94% 80% 60% 51% 20% Dowell SF et al. Pediatr Infect Dis J 1999 38 .

cefixime. flu or M. cat coverage at all   Palatability issue for suspension 39 .Clindamycin (Cleocin®) If HD Amoxicillin Failure   Excellent pneumococcal coverage  Active against 80-85% of DRSP strains Requires co-therapy with agent active against H flu (Bactrim.) NO H. etc.

30 mg/kg/day TID (max 1800 mg/day)  Dosage forms   Suspension Capsules 40 .Clindamycin: Cleocin®   Class   Adverse Events     Lincosamide NO coverage-H. flu or M. cat Considerations     15% cross resistance with DRSP Consider in combo tx for penicillin allergic patients Tastes awful Nausea/vomiting Diarrhea Rash Increased LFT’s  Contraindications  Hypersensitivity to clindamycin  Dosing  10 .

Macrolides If HD Amoxicillin Failure Erythromycin – Azithromycin.Clarithromycin 80% of penicillin intermediate and 50% of resistant strains remain fully susceptible to macrolides  H. influenza coverage generally less susceptible than with beta-lactams  All have good M. cattarhallis coverage  41 .

Azithromycin   Class   Adverse Events     Macrolide DRSP ~ 50% cross resistance Decreased H. flu coverage Tastes okay .aftertaste Considerations    Nausea/vomiting Diarrhea Abdominal pain Rash Hypersensitivity to macrolides  Contraindications   Dosing    10 mg/kg x1 dose then 5 mg/kg QD for 4 days  Dosage forms (max 500mg/250 mg)  Injection 10 mg/kg QD for 3 days  Suspension (max 500 mg)  Tablet 30 mg/kg x 1 (max 1500 mg) 42 .

cattarhallis coverage Dosing: 6-12 mg/kg/day BID 43 .Trimethoprim/Sulfamethoxazole (Bactrim®)    20% of DRSP strains remain fully susceptible to Bactrim and significantly lower level of activity than with macrolides or clindamycin H. influenza and M.

Is it Rational to Treat AOM with Antibiotics to Prevent Mastoiditis?  Dutch strategy vs. US practice (100.600 fewer adverse drug effects in Netherlands  # needed to treat = 3.20:140-4 44 .800 more antibiotic prescriptions in US 1.900 to prevent 1 episode mastoiditis   Estimated antibiotic $ to prevent 1 episode = $117.000 children/year):    2 additional mastoiditis cases in Netherlands 7.000 (assumption $30/Rx) 800 ADRs to prevent 1 episode mastoiditis  Additional cost to manage ADE? PIDJ 2001.