Table 2.
Characteristics of patients and exacerbations on day 1 of treatment
| Amoxicillin–clavulanate (n=63) | Azithromycin (n=67) | Placebo (n=67) | ||
|---|---|---|---|---|
| Age, years | 6·7 (3·7–10·0) | 6·1 (3·8–9·4) | 6·3 (4·6–9·5) | |
| Weight, kg | 21·3 (15·4–33·6) | 22·3 (16·9–50·1) | 22·5 (17·1–47·8) | |
| Cough score18 | 3 (3–4) | 3 (3–4) | 3 (2–4) | |
| Days between start of exacerbation and commencing study drug | 3 (2–5) | 3 (3–5) | 4 (3–5) | |
| Fever present | 7/63 (11%) | 13/67 (19%) | 10/67 (15%) | |
| Oxygen saturation, %* | 98 (97–99), n=45 | 98 (98–99), n=46 | 98 (97–100), n=59 | |
| Respiratory rate, breaths per min* | 24 (20–27), n=45 | 24 (22–28), n=46 | 24 (22–26), n=59 | |
| Wheeze present* | 8/48 (17%) | 11/47 (23%) | 10/61 (16%) | |
| Auscultatory crackles* | 18/48 (38%) | 21/47 (45%) | 23/61 (38%) | |
| Abnormal ear, nose, and throat examination* | 36/48 (75%) | 38/47 (81%) | 50/61 (82%) | |
| PC-QOL score15 | 4·6 (2·9–5·7), n=58 | 4·1 (3·2–5·2), n=60 | 4·6 (3·7–5·7), n=61 | |
| White blood cell count, × 109/L* | 9·3 (6·8–11·2), n=18 | 9·2 (6·7–9·8), n=13 | 9·0 (7·6–10·3), n=25 | |
| C-reactive protein concentration, mg/L* | 2·3 (2·0–7·1), n=15 | 2·0 (2·0–2·2), n=18 | 5·7 (2·0–15), n=27 | |
| FEV1% predicted* | 81·0 (73·0–89·0), n=15 | 92·0 (76·0–98·0), n=11 | 86·0 (79·0–96·0), n=23 | |
| Respiratory virus detected* | 31/49 (63%) | 31/51 (61%) | 20/54 (37%) | |
| Atypical bacterial pathogens* | 1/49 (2%) | 5/51 (10%) | 2/54 (4%) | |
| Chlamydia pneumoniae | 0 | 4/51 (8%) | 1/54 (2%) | |
| Mycoplasma pneumoniae | 1/49 (2%) | 1/51 (X%) | 1/54 (2%) | |
Data are median (IQR) or n/N (%). PC-QOL=parent cough-specific quality-of-life.
*
Some children were not seen by a study doctor on day 1 of treatment for their exacerbation, had incomplete information (including blood samples), or were unable to undergo spirometry.