Table 1.
Baseline characteristics of the intention-to-treat population
| Intravenous antibiotic therapy (n=137) | Oral antibiotic therapy (n=148) | ||
|---|---|---|---|
| Age group* | |||
| Infants and toddlers (28 days to 23 months) | 42 (31%) | 28 (19%) | |
| Children (2 to 11 years) | 71 (52%) | 92 (62%) | |
| Adolescents (12 to 17 years) | 18 (13%) | 19 (13%) | |
| Adults (18 to 64 years) | 6 (4%) | 9 (6%) | |
| Sex | |||
| Male | 63 (46%) | 67 (45%) | |
| Female | 74 (54%) | 81 (55%) | |
| Pseudomonas aeruginosa | |||
| Naive | 81 (59%) | 93 (63%) | |
| Free | 56 (41%) | 55 (37%) | |
| Pseudomonas aeruginosa confirmed by | |||
| Bronchoscopy lavage | 0 | 3 (2%) | |
| Cough plate | 5 (4%) | 4 (3%) | |
| Cough swab | 91 (66%) | 91 (61%) | |
| Cough swab and sputum sample | 0 | 1 (1%) | |
| Cough swab and throat swab | 0 | 1 (1%) | |
| Oropharyngeal aspirate | 1 (1%) | 0 | |
| Nasopharyngeal aspirate | 0 | 1 (1%) | |
| Sputum sample (not induced) | 34 (25%) | 39 (26%) | |
| Sputum sample (induced) | 3 (2%) | 5 (3%) | |
| Throat swab | 2 (1%) | 3 (2%) | |
| Unknown | 1 (1%) | 0 | |
| Other micro-organisms detected | |||
| Candida albicans | 11 (8%) | 17 (11%) | |
| MRSA† | 0 | 2 (1%) | |
| Burkholderia cepacia complex | 0 | 0 | |
| Aspergillus fumigatus | 2 (1%) | 2 (1%) | |
| Other organisms | 26 (19%) | 31 (21%) | |
| Genotype | |||
| p·Phe508del and p·Phe508del | 70 (51%) | 90 (61%) | |
| p·Phe508del and other | 40 (29%) | 43 (29%) | |
| p·Phe508del and unknown | 4 (3%) | 5 (3%) | |
| Other and other | 12 (9%) | 7 (5%) | |
| Unknown | 11 (8%) | 3 (2%) | |
| Pulmonary exacerbation20 present | 18 (13%) | 17 (11%) | |
| BMI Z score (paediatric)† | n=125; 0·3 (1) | n=131; 0·3 (0·9) | |
| BMI (adults; m/kg2)† | n=6; 24·6 (1·8) | n=9; 23·2 (2·3) | |
| Time from P aeruginosa isolation to treatment initiation (days)† | n=126; 9 (5) | n=145; 7 (5) | |
| FEV1percentage predicted (l)† | n=67; 86·6 (15·8) | n=70; 85·7 (16) | |
| FVC percentage predicted (l)† | n=67; 92·2 (15·5) | n=70; 95·1 (14·5) | |
| FEF25–75 %predicted (l)† | n=44; 72·7 (26·6) | n=53; 70·6 (30·3) | |
| O2 saturation (%)† | n=118; 97·7 (1·4%) | n=133; 97·7 (1·7%) | |
Data are n (%), mean (SD) or n/N (%). MRSA=methicillin resistant Staphylococcus aureus. BMI=body-mass index.
*
Date of birth was not provided for two participants to allow age to be calculated. Age at randomisation was provided after database lock and analysis and added to the baseline table manually.
†
Data not available for all randomly assigned patients.