Table 1.
Characteristics of randomly allocated participants at enrolment
| Amoxicillin–clavulanate (n=63) | Azithromycin (n=67) | Placebo (n=67) | ||
|---|---|---|---|---|
| Sociodemographic | ||||
| Age, years | 6·0 (3·6–9·5) | 5·9 (3·4–8·7) | 6·0 (3·7–8·6) | |
| Sex | ||||
| Male | 33 (52%) | 33 (49%) | 38 (57%) | |
| Female | 30 (48%) | 34 (51%) | 29 (43%) | |
| Indigenous ethnicity | 28 (44%) | 30 (45%) | 30 (45%) | |
| Medical history | ||||
| Preterm birth (<37 weeks' gestation) | 21/60 (35%) | 10/62 (16%) | 15/64 (23%) | |
| Breastfeeding (ever in infancy) | 45 (71%) | 53 (79%) | 47 (70%) | |
| Tobacco smoke exposure | 14 (22%) | 18 (27%) | 23 (34%) | |
| Age at diagnosis of bronchiectasis, years | 3·3 (1·9–5·8) | 3·3 (1·9–5·5) | 3·2 (1·8–5·8) | |
| Number of lobes affected | 3 (2–3·5) | 2 (2–3) | 3 (2–4) | |
| Number of non-hospitalised exacerbations in past 12 months | 3 (2–5·5) | 3·5 (2–5) | 3 (1–5) | |
| Number of hospitalisations in past 2 years for bronchiectasis exacerbations | 1 (0–2) | 1 (0–2) | 1 (0–1) | |
| Long-term (>4 weeks) use of non-macrolide antibiotics | 6 (10%) | 5 (7%) | 3 (4%) | |
| Trimethoprim–sulfamethoxazole | 6 (10%) | 4 (6%) | 3 (4%) | |
| Doxycycline | 0 | 1 (1%) | 0 | |
| Underlying cause of bronchiectasis | n=62 | n=65 | n=67 | |
| Post-infectious | 44 (71%) | 45 (69%) | 40 (60%) | |
| Idiopathic | 10 (16%) | 12 (18%) | 15 (22%) | |
| Immunodeficiency | 0 | 0 | 2 (3%) | |
| Aspiration | 4 (6%) | 3 (5%) | 7 (10%) | |
| Primary ciliary dyskinesia | 1 (2%) | 2 (3%) | 2 (3%) | |
| Other | 3 (5%) | 3 (5%) | 1 (1%) | |
| Comorbidities | ||||
| Tracheomalacia | 5 (8%) | 11 (16%) | 7 (10%) | |
| Syndromic (eg, trisomy 21) | 3 (5%) | 2 (3%) | 3 (4%) | |
| Asthma | 14 (22%) | 15 (22%) | 15 (22%) | |
| Examination findings | ||||
| Weight at enrolment, kg | 21·7 (15·5–32·3) | 21·55 (16·6–40·9) | 21·2 (15·6–36·4) | |
| Oxygen saturation, % | 99 (98–100), n=52 | 99 (98–99·5), n=60 | 99 (98–100), n=62 | |
| Cough score18 | 1 (0–1) | 1 (0–2) | 1 (0–2) | |
| Digital clubbing | 9 (14%) | 12 (18%) | 13 (19%) | |
| Chest wall deformity | 14 (22%) | 18 (27%) | 15 (22%) | |
| Wheeze at baseline | 1 (2%) | 1 (1%) | 3 (4%) | |
| Crackles at baseline | 2 (3%) | 2 (3%) | 4 (6%) | |
| FEV1% predicted | 91·0 (82·0–100·0), n=33 | 91·0 (81·0–97·0), n=27 | 90·5 (79·0–103·0), n=34 | |
| PC-QOL score15 | 6·1 (4·3–6·8) | 6·3 (5·2–6·9) | 6·5 (4·3–7·0) | |
| Serum biomarkers | ||||
| White blood cell count, × 109/L | 8·2 (7·4–9·3), n=29 | 8·1 (6·7–9·4), n=25 | 8·3 (6·3–9·6), n=30 | |
| C-reactive protein concentration, mg/L | 2 (2–2), n=30 | 2 (2–2), n=25 | 2 (2–2), n=30 | |
Data are median (IQR), n (%), or n/N (%). PC-QOL=parent cough-specific quality-of-life.