Adjunct prednisone in community-acquired pneumonia: 180-day outcome of a multicentre, double-blind, randomized, placebo-controlled trial

Table 2 Overview of primary and secondary endpoints

Endpoints	Placebo (n = 366)	Prednisone (n = 361)	Adjusted HR or OR (95%CI)^a	P value
Primary endpoint
Death from any cause – no. (%)	25 (6.8%)	35 (9.7%)	HR 1.15 (0.68–1.95)	0.601
Secondary endpoints
CAP-related death	7 (1.9%)	6 (1.7%)	OR 0.75 (0.24–2.33)	0.624
Re-Hospitalization – no. (%)	55 (15.0%)	70 (19.4%)	OR 1.33 (0.90–1.96)	0.158
Reason for re-hospitalization – no. (%)
- Recurrent pneumonia	5 (9%)	21 (30%)
- Other infection	3 (5.5%)	4 (5.7%)
- other	41 (74.5%)	39 (55.7%)
- not reported	6 (11%)	6 (8.6%)
Recurrent pneumonia – no. (%)	12 (3.3%)	29 (8.0%)	OR 2.57 (1.29–5.12)	0.007
Secondary infections	35 (9.6%)	62 (17.2%)	OR 1.94 (1.25–3.03)	0.003
Type of infection
- dermatological	1 (3%)	5 (8%)
- urogenital	10 (29%)	9 (15%)
- pulmonary	12 (35%)	18 (30%)
- intestinal	10 (29%)	22 (37%)
- endocardium or foreign body	1 (3%)	4 (7%)
- both urogenital and pulmonary	0 (0%)	2 (3%)
Empyema	7 (1.9%)	3 (0.8%)	OR 0.44 (0.11–1.73)	0.242
New hypertension at day 180	6 (1.6%)	11 (3.0%)	OR 1.90 (0.69–5.18)	0.213
New insulin dependence at day 180	1 (0.3%)	9 (2.5%)	OR 8.73 (1.10–69.62)	0.041

Data are number (%) unless otherwise stated. HR hazard ratio. OR odds ratio. CI confidence interval. CAP community-acquired pneumonia
^aAdjusted for PSI^# and age
^#PSI pneumonia severity index. The PSI is a clinical prediction rule to calculate the probability of morbidity and mortality in patients with community-acquired pneumonia; PSI risk class I corresponds to age ≤ 50 years, and no risk factors (≤50 points), risk class II to < 70 points, risk class III to 71–90 points, risk class IV to 91–130 points, and risk class V to > 130 points [20]

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