1. Effect of antimicrobial treatment on relapses of acute otitis media
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Effect of antimicrobial treatment on relapses of acute otitis media
Aino Ruohola, Miia K. Laine, Paula A. Tähtinen
Dept. of Pediatrics and Adolescent Medicine
Turku University Hospital, Finland
University of Turku, Finland

2. AIM
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To investigate the effect of antimicrobial treatment on relapses of acute otitis media (AOM)

3. Previous results
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Tähtinen, NEJM, 2011

4. Previous results
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Tähtinen, NEJM, 2011
Ruohola, JPIDS, 2017

5. AIM
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To investigate the effect of antimicrobial treatment on relapses of acute otitis media (AOM)

6. METHODS
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Inclusion
6 – 35 mo
AOM, stringent dg (> 90% had bulging TM)
Exclusion
Ongoing antimicrobial treatment
AOM with spontaneous perforation
Allergy to pen/amox
Down syndrome/cleft palate/immunodeficiency

7. METHODS 746 enrollment visits  322 randomized
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746 enrollment visits  322 randomized
Randomized, double-blind, placebo-controlled trial
Amox-cla 40 mg/kg/day, for 7 days
Follow-up days: 1, 3, 8, 15, 30, 60, additionally any day
Relapse: appearance or remarkable deterioration of symptoms and signs of AOM between study days 9-18

8. RESULTS
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At entry Amox-kla, n=159 Placebo, n=155 Age, mean (range), mo 16 (6-35) 16 (6-35) Male gender 90 (57%) 88 (57%) Family history of OM 89 (56%) 95 (61%) Siblings in the household 89 (56%) 91 (59%) Day care attendance 86 (54%) 83 (54%) Current use of pacifier 79 (50%) 83 (54%) Parental smoking 56 (35%) 46 (30%) ≥4 previous AOM 30 (19%) 28 (18%) AOM ≤ previous mo 36 (23%) 30 (19%) Unilateral AOM 97/157 (62%) 86/153 (56%) Severe bulging of TM 44 (28%) 39 (25%) Peaked tympanogram 32 (20%) 24 (16%)

9. RESULTS
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At entry Amox-kla, n=159 Placebo, n=155 Age, mean (range), mo 16 (6-35) 16 (6-35) Male gender 90 (57%) 88 (57%) Family history of OM 89 (56%) 95 (61%) Siblings in the household 89 (56%) 91 (59%) Day care attendance 86 (54%) 83 (54%) Current use of pacifier 79 (50%) 83 (54%) Parental smoking 56 (35%) 46 (30%) ≥4 previous AOM 30 (19%) 28 (18%) AOM ≤ previous mo 36 (23%) 30 (19%) Unilateral AOM 97/157 (62%) 86/153 (56%) Severe bulging of TM 44 (28%) 39 (25%) Peaked tympanogram 32 (20%) 24 (16%)

10. RESULTS
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At entry Amox-kla, n=159 Placebo, n=155 Age, mean (range), mo 16 (6-35) 16 (6-35) Male gender 90 (57%) 88 (57%) Family history of OM 89 (56%) 95 (61%) Siblings in the household 89 (56%) 91 (59%) Day care attendance 86 (54%) 83 (54%) Current use of pacifier 79 (50%) 83 (54%) Parental smoking 56 (35%) 46 (30%) ≥4 previous AOM 30 (19%) 28 (18%) AOM ≤ previous mo 36 (23%) 30 (19%) Unilateral AOM 97/157 (62%) 86/153 (56%) Severe bulging of TM 44 (28%) 39 (25%) Peaked tympanogram 32 (20%) 24 (16%)

11. RESULTS
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At entry Amox-kla, n=159 Placebo, n=155 Age, mean (range), mo 16 (6-35) 16 (6-35) Male gender 90 (57%) 88 (57%) Family history of OM 89 (56%) 95 (61%) Siblings in the household 89 (56%) 91 (59%) Day care attendance 86 (54%) 83 (54%) Current use of pacifier 79 (50%) 83 (54%) Parental smoking 56 (35%) 46 (30%) ≥4 previous AOM 30 (19%) 28 (18%) AOM ≤ previous mo 36 (23%) 30 (19%) Unilateral AOM 97/157 (62%) 86/153 (56%) Severe bulging of TM 44 (28%) 39 (25%) Peaked tympanogram 32 (20%) 24 (16%)

12. RESULTS
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At entry Amox-kla, n=159 Placebo, n=155 Age, mean (range), mo 16 (6-35) 16 (6-35) Male gender 90 (57%) 88 (57%) Family history of OM 89 (56%) 95 (61%) Siblings in the household 89 (56%) 91 (59%) Day care attendance 86 (54%) 83 (54%) Current use of pacifier 79 (50%) 83 (54%) Parental smoking 56 (35%) 46 (30%) ≥4 previous AOM 30 (19%) 28 (18%) AOM ≤ previous mo 36 (23%) 30 (19%) Unilateral AOM 97/157 (62%) 86/153 (56%) Severe bulging of TM 44 (28%) 39 (25%) Peaked tympanogram 32 (20%) 24 (16%)

13. RESULTS
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At entry Amox-kla, n=159 Placebo, n=155 Age, mean (range), mo 16 (6-35) 16 (6-35) Male gender 90 (57%) 88 (57%) Family history of OM 89 (56%) 95 (61%) Siblings in the household 89 (56%) 91 (59%) Day care attendance 86 (54%) 83 (54%) Current use of pacifier 79 (50%) 83 (54%) Parental smoking 56 (35%) 46 (30%) ≥4 previous AOM 30 (19%) 28 (18%) AOM ≤ previous mo 36 (23%) 30 (19%) Unilateral AOM 97/157 (62%) 86/153 (56%) Severe bulging of TM 44 (28%) 39 (25%) Peaked tympanogram 32 (20%) 24 (16%)

14. RESULTS
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At entry Amox-kla, n=159 Placebo, n=155 Age, mean (range), mo 16 (6-35) 16 (6-35) Male gender 90 (57%) 88 (57%) Family history of OM 89 (56%) 95 (61%) Siblings in the household 89 (56%) 91 (59%) Day care attendance 86 (54%) 83 (54%) Current use of pacifier 79 (50%) 83 (54%) Parental smoking 56 (35%) 46 (30%) ≥4 previous AOM 30 (19%) 28 (18%) AOM ≤ previous mo 36 (23%) 30 (19%) Unilateral AOM 97/157 (62%) 86/153 (56%) Severe bulging of TM 44 (28%) 39 (25%) Peaked tympanogram 32 (20%) 24 (16%)

15. RESULTS
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Mo Amox-kla Placebo Mo n=159 n=155 Relapse of AOM 25 (16%) 30 (19%) (P=0.40)

16. RESULTS
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At entry After treatment period during follow-up Age < 24 mo Persistence of MEE Male gender Respiratory viral infection Family history of OM NP bacterial colonization Siblings in the household Day care attendance Current use of pacifier Parental smoking ≥4 previous AOM AOM ≤ previous mo Unilateral AOM Severe bulging of TM Peaked tympanogram

17. RESULTS
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At entry After treatment period during follow-up Age < 24 mo Persistence of MEE OR 4.6 ( ) Male gender Respiratory viral infection OR 3.1 ( ) Family history of OM NP bacterial colonization OR 4.0 ( ) Siblings in the household Day care attendance Current use of pacifier Parental smoking OR 2.0 ( ) ≥4 previous AOM AOM ≤ previous mo Unilateral AOM Severe bulging of TM Peaked tympanogram

18. CONCLUSION
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Treatment of AOM with an antimicrobial with adequate coverage does not affect the development of a relapse after AOM
Persistence of MEE, subsequent respiratory viral infection, nasopharyngeal bacterial colonization, and parental smoking predispose young children to a relapse of AOM

19. ACKNOWLEDGEMENTS
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Paula A. Tähtinen
Miia K. Laine