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
• To investigate the effect of antimicrobial treatment on
relapses of acute otitis media (AOM)
Previous results
Tähtinen, NEJM, 2011
Previous results
Tähtinen, NEJM, 2011
Ruohola, JPIDS, 2017
AIM
• To investigate the effect of antimicrobial treatment on
relapses of acute otitis media (AOM)
METHODS
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
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
At entry
Age, mean (range), mo
Male gender
Family history of OM
Siblings in the household
Day care attendance
Current use of pacifier
Parental smoking
Amox-kla, n=159
16 (6-35)
90 (57%)
89 (56%)
89 (56%)
86 (54%)
79 (50%)
56 (35%)
Placebo, n=155
16 (6-35)
88 (57%)
95 (61%)
91 (59%)
83 (54%)
83 (54%)
46 (30%)
≥4 previous AOM
AOM ≤ previous mo
30 (19%)
36 (23%)
28 (18%)
30 (19%)
Unilateral AOM
Severe bulging of TM
Peaked tympanogram
97/157 (62%)
44 (28%)
32 (20%)
86/153 (56%)
39 (25%)
24 (16%)
RESULTS
At entry
Age, mean (range), mo
Male gender
Family history of OM
Siblings in the household
Day care attendance
Current use of pacifier
Parental smoking
Amox-kla, n=159
16 (6-35)
90 (57%)
89 (56%)
89 (56%)
86 (54%)
79 (50%)
56 (35%)
Placebo, n=155
16 (6-35)
88 (57%)
95 (61%)
91 (59%)
83 (54%)
83 (54%)
46 (30%)
≥4 previous AOM
AOM ≤ previous mo
30 (19%)
36 (23%)
28 (18%)
30 (19%)
Unilateral AOM
Severe bulging of TM
Peaked tympanogram
97/157 (62%)
44 (28%)
32 (20%)
86/153 (56%)
39 (25%)
24 (16%)
RESULTS
At entry
Age, mean (range), mo
Male gender
Family history of OM
Siblings in the household
Day care attendance
Current use of pacifier
Parental smoking
Amox-kla, n=159
16 (6-35)
90 (57%)
89 (56%)
89 (56%)
86 (54%)
79 (50%)
56 (35%)
Placebo, n=155
16 (6-35)
88 (57%)
95 (61%)
91 (59%)
83 (54%)
83 (54%)
46 (30%)
≥4 previous AOM
AOM ≤ previous mo
30 (19%)
36 (23%)
28 (18%)
30 (19%)
Unilateral AOM
Severe bulging of TM
Peaked tympanogram
97/157 (62%)
44 (28%)
32 (20%)
86/153 (56%)
39 (25%)
24 (16%)
RESULTS
At entry
Age, mean (range), mo
Male gender
Family history of OM
Siblings in the household
Day care attendance
Current use of pacifier
Parental smoking
Amox-kla, n=159
16 (6-35)
90 (57%)
89 (56%)
89 (56%)
86 (54%)
79 (50%)
56 (35%)
Placebo, n=155
16 (6-35)
88 (57%)
95 (61%)
91 (59%)
83 (54%)
83 (54%)
46 (30%)
≥4 previous AOM
AOM ≤ previous mo
30 (19%)
36 (23%)
28 (18%)
30 (19%)
Unilateral AOM
Severe bulging of TM
Peaked tympanogram
97/157 (62%)
44 (28%)
32 (20%)
86/153 (56%)
39 (25%)
24 (16%)
RESULTS
At entry
Age, mean (range), mo
Male gender
Family history of OM
Siblings in the household
Day care attendance
Current use of pacifier
Parental smoking
Amox-kla, n=159
16 (6-35)
90 (57%)
89 (56%)
89 (56%)
86 (54%)
79 (50%)
56 (35%)
Placebo, n=155
16 (6-35)
88 (57%)
95 (61%)
91 (59%)
83 (54%)
83 (54%)
46 (30%)
≥4 previous AOM
AOM ≤ previous mo
30 (19%)
36 (23%)
28 (18%)
30 (19%)
Unilateral AOM
Severe bulging of TM
Peaked tympanogram
97/157 (62%)
44 (28%)
32 (20%)
86/153 (56%)
39 (25%)
24 (16%)
RESULTS
At entry
Age, mean (range), mo
Male gender
Family history of OM
Siblings in the household
Day care attendance
Current use of pacifier
Parental smoking
Amox-kla, n=159
16 (6-35)
90 (57%)
89 (56%)
89 (56%)
86 (54%)
79 (50%)
56 (35%)
Placebo, n=155
16 (6-35)
88 (57%)
95 (61%)
91 (59%)
83 (54%)
83 (54%)
46 (30%)
≥4 previous AOM
AOM ≤ previous mo
30 (19%)
36 (23%)
28 (18%)
30 (19%)
Unilateral AOM
Severe bulging of TM
Peaked tympanogram
97/157 (62%)
44 (28%)
32 (20%)
86/153 (56%)
39 (25%)
24 (16%)
RESULTS
At entry
Age, mean (range), mo
Male gender
Family history of OM
Siblings in the household
Day care attendance
Current use of pacifier
Parental smoking
Amox-kla, n=159
16 (6-35)
90 (57%)
89 (56%)
89 (56%)
86 (54%)
79 (50%)
56 (35%)
Placebo, n=155
16 (6-35)
88 (57%)
95 (61%)
91 (59%)
83 (54%)
83 (54%)
46 (30%)
≥4 previous AOM
AOM ≤ previous mo
30 (19%)
36 (23%)
28 (18%)
30 (19%)
Unilateral AOM
Severe bulging of TM
Peaked tympanogram
97/157 (62%)
44 (28%)
32 (20%)
86/153 (56%)
39 (25%)
24 (16%)
RESULTS
Mo
Mo
Amox-kla
n=159
Placebo
n=155
Relapse of AOM
25 (16%)
30 (19%)
(P=0.40)
RESULTS
At entry
Age < 24 mo
Male gender
Family history of OM
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
After treatment period during follow-up
Persistence of MEE
Respiratory viral infection
NP bacterial colonization
RESULTS
At entry
Age < 24 mo
Male gender
Family history of OM
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
After treatment period during follow-up
Persistence of MEE
OR 4.6 (2.1-9.9)
Respiratory viral infection
OR 3.1 (1.4-6.9)
NP bacterial colonization
OR 4.0 (1.5-11.0)
CONCLUSION
• 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
Paula A. Tähtinen
Miia K. Laine