Placebo | Azithromycin | p-value | |
Subjects n | 43 | 40 | |
Donor age at transplantation yrs | 44.0 (37.0–54.0) | 51.0 (36.5–57.5) | 0.20 |
Recipient age at transplantation yrs | 55.1 (44.2–59.4) | 56.1 (47.7–61.2) | 0.76 |
Males/females | 20/23 (46.5/53.5) | 17/23 (42.5/57.5) | 0.71 |
Underlying disease | 0.57 | ||
Emphysema (COPD) | 24 (55.8) | 17 (42.5) | |
Pulmonary fibrosis | 10 (23.3) | 9 (22.5) | |
Cystic fibrosis | 6 (13.9) | 8 (20.0) | |
α1-Antitrypsin deficiency | 2 (4.7) | 1 (2.5) | |
Pulmonary arterial hypertension | 0 (0.0) | 2 (5.0) | |
Asthma | 1 (2.3) | 1 (2.5) | |
Bronchiectasis | 0 (0.0) | 1 (2.5) | |
Lymphangioleiomyomatosis | 0 (0.0) | 1 (2.5) | |
Type of transplantation | 0.23 | ||
SSLTx | 33 (76.7) | 26 (65.0) | |
SLTx | 10 (23.3) | 12 (30.0) | |
HLTx | 0 (0.0) | 2 (5.0) | |
Donor–recipient CMV mismatch# | 9 (20.9) | 9 (22.5) | 0.86 |
Ischaemic time¶ min | 344.0±108.7 | 341.4±86.6 | 0.88 |
PGD score+ | |||
Mean PGD score T0–T48 | 1.97±0.76 | 1.80±0.82 | 0.32 |
Highest PGD score T0–T48 | 2.49±0.75 | 2.23±0.83 | 0.17 |
ICU stay after transplantation days | 8.9±6.7 | 7.5±5.3 | 0.33 |
Hospitalisation after transplantation days | 30.9±8.7 | 34.9±25.2 | 0.82 |
Time from transplantation to start study treatment days | 36.1±9.4 | 35.8±12.0 | 0.50 |
Total duration of study treatment days | 498.2±224.7 | 565.7±224.5 | 0.17 |
Duration of total follow-up days | 1013.0±371.6 | 997.8±303.0 | 0.57 |
Data are presented as median (interquartile range), n (%) or mean±sd, unless otherwise stated. Patients' characteristics for the patients of the placebo-arm (n = 43) and of the azithromycin-arm (n = 40). Groups were compared using unpaired, two-tailed t-tests, Mann–Whitney tests or Chi-squared tests. COPD: chronic obstructive pulmonary disease; SSLTx: sequential single-lung transplant; SLTx: single-lung transplant; HLTx: heart–lung transplant; CMV: cytomegalovirus; PGD: primary graft dysfunction; ICU: intensive care unit. #: CMV mismatch was defined as a CMV-positive donor and a CMV-negative recipient; ¶: ischaemic time was calculated from the time of ischaemia registered for the second lung in case of bilateral transplantation, the heart–lung block in case of heart–lung transplantation or for the first lung in case of unilateral transplantation; +: PGD was assessed at 0, 12, 24 and 48 h after transplantation, and mean PGD score was calculated for each patient using PGD score at every time-point during this 48-h interval.