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An event is serious (based on the ICH definition) when the patient outcome is:
* death
* life-threatening
* hospitalisation
* disability
* congenital anomaly
* other medically important event
A 43-year-old man developed Klebsiella pneumoniae infection during off-label treatment with dexamethasone for COVID-19.
The man admitted to the emergency department with shortness of breath. Prior to the admission, he was found COVID-19 positive and started receiving off-label treatment with IM dexamethasone 16 mg/day in the home isolation. Six days later, he developed shortness of breath, fever and cough with purulent sputum and presented to the emergency department. Upon admission, his vital sign measurement showed heart rate 115bpm, BP 80/60 mmHg, body temperature 38.5°C and oxygen saturation 82%. His chest CT showed ground-glass opacity and condensation along with peribronchial lines in his right lower lobe of the lung. His laboratory tests showed glucose 332 mg/dL, LDH 530 mg/dL, high-sensitive C-reactive protein 25 mg/L, leukocytes 17.6 × 10 9/L, procalcitonin 12 ng/mL, neutrophils 15.2 × 10 9/L and lymphocytes 1.4 × 10 9/L. He had acute respiratory distress syndrome requiring invasive ventilation. Thus, culture of the bronchoalveolar lavage fluid was tested that showed Klebsiella pneumoniae infection. He also received off-label treatment with tocilizumab and convalescent-anti-SARS-CoV-2-plasma [convalescent plasma] for COVID-19. It was considered that he had Klebsiella pneumoniae infection due to dexamethasone [duration of treatment to reaction onset not stated].
Unspecified antibiotic and insulin were given; however, the man died ten days later [outcome and cause of death not stated].