Levofloxacin/paracetamol

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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 54-year-old man exhibited a lack of efficacy during treatment with paracetamol and levofloxacin for fever and dyspnoea.

The man, who had a history of end-stage renal disease, underwent a renal allograft in 2015. He had been receiving combined maintenance immunosuppressive therapy with everolimus, prednisone and tacrolimus. On 19 March [year not stated], he was admitted to the emergency room with a 5-day history of fever and dyspnoea. Prior to the admission, he received paracetamol and levofloxacin [routes and dosages not stated] with no effect.

On admission, the man's chest X-ray showed multiple bilateral patchy ground-glass opacities, and subsequently, a diagnosis of Covid-19 associated bilateral pneumonia was made. He had a history of left native kidney radical nephrectomy in 2006, focal clear-cell adenocarcinoma, obstructive sleep apnoea syndrome and hypertension. Concomitantly, he had been receiving enalapril, doxazosin and manidipine. Subsequently, he started receiving off-label treatment with piperacillin/tazobactam (piperacillin 4/tazobactam 0.5) every 8h, azithromycin 250mg once daily and hydroxychloroquine 200mg once daily. His immunosuppressive treatment with everolimus was stopped, while the dosage of tacrolimus was reduced. On day 4 of admission, off-label treatment with lopinavir/ritonavir (lopinavir 400mg/ritonavir 100mg) every 12h was added to his treatment regimen. On day 6, he developed progressive respiratory failure, which required mechanical ventilation in the ICU. At the same time, immunosuppressive treatment was stopped. Subsequently, he started receiving off-label treatment with IV methylprednisolone [6-methylprednisolone] 40mg every 24h. He received a total of 4 doses of lopinavir/ritonavir, and one dose of off-label interferon-β 250µg on day 7. In the first 48h at the ICU, his general condition worsened, and he developed oliguric acute kidney failure with active urine sediment. Hence, he received continuous renal replacement therapy (CRRT). Laboratory findings indicated cytokine-storm. Therefore, he received a 3-day consecutive course of off-label high-dose IV immune globulin (IVIG) 65 g/day (an accumulated 2.2 g/kg) and methylprednisolone 125 mg/day on days 9, 10 and 11. Post-treatment, his condition improved with haemodyanamic stabilisation. Treatment with CRRT was stopped. Afterwards, he received alternative-day renal replacement therapy with haemodialysis for further 13 days. After 23 days, he was extubated and remained in the ICU for a total of 30 days. After recovery of renal function and diuresis, treatment with prednisone and tacrolimus was re-started on day 36, followed by everolimus after one week. On day 41, he tested negative for COVID-19. After 49 days of hospitalisation, he was discharged from the hospital.