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Proportion of Resistant Pnc (%) to Various Antibiotic Categories - MEF Southern Israel 1992 - 2002

Proportion of Resistant Pnc (%) to Various Antibiotic Categories - MEF Southern Israel 1992 - 2002. N = 3,543. “Hand Tailored” AOM Drugs Studies. Characteristics DRUG Weak well tolerated Strong, less well tolerated. Study population

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Proportion of Resistant Pnc (%) to Various Antibiotic Categories - MEF Southern Israel 1992 - 2002

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  1. Proportion of Resistant Pnc (%) to Various Antibiotic Categories - MEF Southern Israel 1992 - 2002 N = 3,543

  2. “Hand Tailored” AOM Drugs Studies Characteristics DRUG Weak well tolerated Strong, less well tolerated Study population Age > 24m < 24m DCC avoid as many as you can Older siblings at home avoid as many as you can Recurrent/non-responsive avoid as many as you can Baseline clinical symptom Cx (+) + TM findings Outcomes Tolerability much emphasis less emphasis Convenience much emphasis less emphasis Bacteriological efficacy do not include main outcome Main clinical outcome test of cure end of Rx (d = 28-42) (d = 11-12) Conclusions based on equivalence based on bacteriologic of clinical outcome and and clinical efficacy superiority of tolerability/ in “difficult to treat” convenience cases

  3. ‘Time - dependent’ ‘concentration-dependent’ Antibiotic concentration MIC MIC Time dose dose ‘Time and Concentration Above MIC’ concept - Pharmacodynamical Approach Antibiotic concentration 40 - 50% Time dose dose Penicillins Cephalosporins Clindamycin TMP/SMX Quinolones Aminoglycoside Macrolides

  4. b a c TYMPANOCENTESIS CULTURE The Double-Tympanocentesis Method TREATMENT day 1 day 4-6 day 10-12 day 21-30

  5. 84% 52% % persistence placebo cefac(40) cef-axet(40) CROx1(50) amox/augm(40-50) Ts Azith(3;5d) CROx3(50) * for amoxicilline only AugES-600(90)

  6. NG 20 (18%) True Relapse 30 (28%) New Infection 58 (54%) Clinical Recurrence After Completion of Rx vs Bacteriologic Relapse Leibovitz et al, PIDJ 2003 Clinical recurrence after bacteriologic eradication (N=108)

  7. n=39 n=38 n=10 n=21 100 90 80 70 % True bacteriologic relapses of all clinical recurrent AOM 60 P=0.01 A) 50 40 41 % 30 20 26 % 14 % 10 10 % 0 1-7 8-14 15-21 22-28 Days after completion of therapy S. pneumoniae H. influenzae new infection true relapse n=42 n=12 n=27 n=18 100 % 100 % 60 % 90 % 90 % 60% 100 % 80 % True relapses (%) 56 % 80 % 67 % 70 % 70 % 60 % 60 % B) % 100 50 % P=NS 50 % P=0.01 40 % 40 % 30 % 30 % 40 % 0 % 44 % 33 % 40 % 20 % 20 % 17/42 0/12 6/18 12/27 10 % 10 % 0 % 0 % 1 - 14 15 - 28 1 -14 15 - 28 Days after completion of therapy Days after completion of therapy Distribution of the 35 pathogens in 30 patients with true bacteriologic AOM relapses according to timing of clinical recurrence of AOM

  8. Clinical vs. Bacteriological Outcome of 123 Children with AOM with Initial Positive MEF Cx P <.001 36 (63%) 64 (97%) CURE 2 (3%) 21 (37%) FAILURE Cx result on day 4-5 Cx (+) n = 57 Cx (-) n = 66 Dagan et al. Pediatr Infect Dis J 17:776-82, 1998

  9. No. pathogens = 56 No. patients = 43 No. pathogens = 16 No. patients = 13 MC 6% GAS 2% MC 2% PRSP 25% ßL (-) HI 19% PRSP 30% ßL (-) HI 36% 1 1 1 3 4 17 20 4 13 8 PSSP 7% ßL (+) HI 50% ßL (+) HI 23% Day 4-6 Day 1 No. ßL (+) organisms = 9/16 (56%) No. ßL (+) organisms = 14/56 (25%) P=0.04 High Dose Amoxicillin (80mg/Kg/d): MEF Pathogens in Bacteriologic Failure Leibovitz et al, 40th ICAAC, 2000

  10. Amox (n=52) Placebo (n=35) P = .014 63 54 52 P = 0.017 35 24 4 Initial Failure (Tx modified) Effusion at 2w Effusion at 6w Severe AOM Kaleida et al, Pediatr 87:466-74, 1991 Age ≥ 2 yrs 80 60 % with failure 40 20 0

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