Effect of antimicrobial treatment on relapses of acute otitis media

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Presentation transcript:

Effect of antimicrobial treatment on relapses of acute otitis media Finland 100 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

AIM Finland 100 To investigate the effect of antimicrobial treatment on relapses of acute otitis media (AOM)

Previous results Finland 100 Tähtinen, NEJM, 2011

Previous results Finland 100 Tähtinen, NEJM, 2011 Ruohola, JPIDS, 2017

AIM Finland 100 To investigate the effect of antimicrobial treatment on relapses of acute otitis media (AOM)

METHODS Finland 100 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

METHODS 746 enrollment visits  322 randomized Finland 100 746 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

RESULTS Finland 100 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%)

RESULTS Finland 100 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%)

RESULTS Finland 100 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%)

RESULTS Finland 100 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%)

RESULTS Finland 100 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%)

RESULTS Finland 100 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%)

RESULTS Finland 100 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%)

RESULTS Finland 100 Mo Amox-kla Placebo Mo n=159 n=155 Relapse of AOM 25 (16%) 30 (19%) (P=0.40)

RESULTS Finland 100 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

RESULTS Finland 100 At entry After treatment period during follow-up Age < 24 mo Persistence of MEE OR 4.6 (2.1-9.9) Male gender Respiratory viral infection OR 3.1 (1.4-6.9) Family history of OM NP bacterial colonization OR 4.0 (1.5-11.0) Siblings in the household Day care attendance Current use of pacifier Parental smoking OR 2.0 (1.1-3.9) ≥4 previous AOM AOM ≤ previous mo Unilateral AOM Severe bulging of TM Peaked tympanogram

CONCLUSION Finland 100 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

ACKNOWLEDGEMENTS Finland 100 Paula A. Tähtinen Miia K. Laine