Skip to main content

Table 3 Ear assessments and nasopharyngeal carriage at the end of therapy

From: Compared to placebo, long-term antibiotics resolve otitis media with effusion (OME) and prevent acute otitis media with perforation (AOMwiP) in a high-risk population: A randomized controlled trial

  Amoxicillin Placebo  
  n = 52 n = 51  
Mean duration of therapy (months) 5.7 5.2  
Mean age (months) at the end of therapy 11.5 10.2  
Number of children (%) with the following worst ear status at the end of therapy    
  Amoxicillin Placebo Risk Difference
  n = 52 n = 51 [95% CI]
Success (bilateral normal ears at 2 successive monthly visits) 5 (9.6%) 0 +9.6% [1.6, 17.6]
Normal 6 (12%) 0 +12% [3, 20]
OME 28 (54%) 26 (51%) +3% [-16, 22]
AOM without perforation 12 (23%) 11 (22%) +1.5% [-15, 18]
AOM with perforation 5 (10%) 11 (22%) -12% [-26, 2]
Dry perforation 0 1 (2%) -2% [-6, 2]
CSOM 1 (2%) 2 (4%) -2% [-9, 5]
Any suppurative OM† 18 (35%) 24 (47%) -12% [-31, 6]
Any perforation‡ 6 (12%) 14 (27%) -16% [-31, -1]
Any active perforation§ 6 (12%) 13 (26%) -14% [-29, 1]
Bilateral AOM without perforation 4 (8%) 7 (13%) +5% [-6, 17]
Bilateral any perforation‡ 1 (2%) 7 (14%) -12% [-22, -2]
Number of children (%) with nasopharyngeal carriage of the following OM pathogens ¥ at end of therapy    
  Amoxicillin Placebo Risk Difference
  n = 50 n = 47 [95% CI]
Streptococcus pneumoniae 29 (58%) 33 (70%) -12% [-31, 7]
non-capsular Haemophilus influenzae 36 (72%) 29 (62%) +10% [-8, 29]
Moraxella catarrhalis 44 (88%) 43 (91%) -3% [-16,9]
All Spn, NCHi and M.cat 23 (46%) 21 (45%) 1% [-19, 21]
Penicillin non-susceptible Spn‡ 17 (34%) 19 (40%) -6% [-26, 13]
Penicillin resistant Spn†† 1 (2%) 2 (4%) -2.3% [-9, 5]
NCHi beta-lactamase positive 6 (12%) 1 (2%) +10% [-0.03, 20]
  1. AOM, AOMwiP or CSOM; ‡ AOMwiP, dry perforation or CSOM; §AOMwiP or CSOM; ¥ Spn Streptococcus pneumoniae. NCHi non-capsular Haemophilus influenzae. Mcat Moraxella catarrhalis. ‡Penicillin intermediate or resistant Spn (MIC > = 0.1 μg/ml) ††Penicillin resistant Spn (MIC > 1.0 μg/ml)