Azithromycin/dexamethasone

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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 61-year-old man developed reactivation of human herpesvirus-8 (HHV-8) infection and disseminated Kaposi's sarcoma (KS) during treatment with azithromycin and off-label dexamethasone for COVID-19 pneumonia [not all routes, dosages and outcomes stated; time to reactions onset not clearly stated].

The man was admitted to the hospital on 9 February 2021 for COVID-19 pneumonia. His medical history included diabetes and arterial hypertension, and co-medications included metformin, bisoprolol and unspecified ACE inhibitor. After a few days, due to respiratory failure, he was transferred to the ICU, started on invasive ventilation and remained intubated for 4 days. During that time, he started receiving remdesivir and off-label IV dexamethasone 6mg daily which was increased to 20mg daily. Additionally, he received antibacterial therapy with ceftriaxone and azithromycin. Blood exams showed transient viral-induced lymphopenia for 10 days. His HIV test was found to be negative. Later, he was transferred to the another hospital for neuromotor rehabilitation. Due to jugular thrombosis in the site of previous central venous catheterisation, enoxaparin sodium [enoxaparin] was added in his treatment. He received dexamethasone therapy for 10 days. He had no signs and symptoms of other infections at that time. At the beginning of March 2021, while in rehabilitation facility, he experienced high fever and abdominal pain. Laboratory workup showed anaemia, thrombocytopenia and high inflammatory markers. Meanwhile, his enoxaparin sodium therapy was discontinued, and he was started on empirical antibacterial therapy with piperacillin/tazobactam and levofloxacin. However, after a week, his clinical condition further deteriorated. Therefore, he was treated with meropenem and linezolid. In view of persistent clinical condition and limited diagnostic resources in the rehabilitation, he was readmitted to the current hospital at the beginning of April 2021. Based on clinical conditions, uncontrolled sepsis, reactivation of a latent infection and a de-novo malignant haematological disease were in differential. Biochemistry revealed anaemia, increased inflammatory parameters, inflammatory aspect of lymphocytes and neutrophils, thrombocytopenia with macro-platelets and hypergammaglobulinaemia. Infectious aetiology and autoimmune panel showed negative results. Neck ultrasound demonstrated multiple non-colliquate and partly confuent adenopathies. Abdomen CT scan showed cholecystitis, splenomegaly, mild pleural effusion, ascending colon coprostasis with proximal dilatation and abdominal and inguinal lymph adenomegalies. His piperacillin/tazobactam therapy was switched to ertapenem and received blood transfusion resulting in improvement in haemoglobin and platelet count was noted with normalisation of inflammatory parameters. A diagnosis of cholecystitis and parainfectious cytopenia was made while awaiting for results of lymph node biopsy, and he was discharged. In May 2021, the histology of the lymph nodal core needle biopsy specimen demonstrated KS. Therefore, he was re-admitted to the hospital. At physical examination, he had purple skin lesions on his forearms, palms, legs and palate, which had appeared a few days before. Over the following 24h, he developed comparable skin lesions on the thorax. The diagnosis of KS was re-confirmed on skin and palate biopsies. GI tract endoscopy did not show suspected lesions. An HHV-8 DNA was detected in plasma. No other active infections were found. The full-body CT scan showed a disseminated disease including liver and spleen lesions, lung parenchymal nodules, inguinal and axillary lymph nodes and deep lymph adenomegalies below and above the diaphragm.

The man was treated with liposomal doxorubicin. After 3 cycles of the well-tolerated chemotherapy, a partial improvement in his skin and mucosal lesions were noted.