Table 2.
Primary and Secondary Study Outcomes
| Study Outcome | Placebo (N = 78) | BCG (N = 72) | Hazard Ratio (95% CI) | p value |
|---|---|---|---|---|
| Incidence at least one new infection until month 12, no. (%)a | 33 (42.3) | 18 (25.0) | 0.55 (0.31–0.97) | 0.039 |
| Respiratory infections of probable viral origin necessitating medical treatment, no. (%) | 14 (17.9) | 3 (4.2) | 0.21 (0.06–0.72) | 0.013 |
| Community-acquired pneumonia, no. (%) | 8 (10.3) | 3 (4.2) | 0.38 (0.10–1.43) | 0.153 |
| Hospital-acquired pneumonia, no. (%) | 2 (2.6) | 0 (0) | – | 0.479 |
| All respiratory infections, no. (%) | 24 (30.1) | 6 (8.3) | 0.25 (0.10–0.60) | 0.002 |
| Intrabdominal infections, no. (%) | 3 (3.8) | 4 (5.6) | 1.39 (0.31–6.21) | 0.667 |
| Urinary tract infections, no. (%) | 6 (7.7) | 8 (11.1) | 1.38 (0.48–3.97) | 0.553 |
| Acute bacterial skin and skin structure infections, no. (%) | 6 (7.7) | 3 (4.2) | 0.51 (0.13–2.02) | 0.335 |
| Bloodstream infection, no. (%) | 2 (2.6) | 0 (0) | – | 0.497 |
| Incidence of second infection until month 12, no. (%) | 9 (11.5) | 5 (6.9) | 0.59 (0.20–1.77) | 0.349 |
| Incidence of third infection until month 12, no. (%) | 3 (3.8) | 1 (1.4) | 0.36 (0.04–3.45) | 0.375 |
| Rate of hospitalization/patient until month 12, mean (SD) | 0.49 (0.72) | 0.43 (0.72) | N/A | 0.383 |
| Patient-infections per year, per 100 patients, no. (%) | 45 (57.7) | 24 (33.3) | N/A | 0.003 |
| Courses of antibiotics until month 12, mean (SD) | 0.69 (1.66) | 0.60 (1.25) | N/A | 0.665 |
| One-year mortality, no. (%) | 14 (17.9) | 10 (13.9) | 0.68 (0.30–1.54) | 0.356 |
CI, confidence interval; N/A, not applicable; SD, standard deviation.
a
Some patients had more than one infection.