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] |