BCG

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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 37-year-old man developed disseminated BCG infection (BCGosis) and tuberculosis following intra-renal instillation of BCG immunotherapy [dosages and duration of treatment to reaction onset not stated].

The man had been diagnosed with right renal pelvis low grade non-invasive papillary upper tract urothelial carcinoma (UTUC). He had undergone a right flexible ureteroscopy and laser ablation for the management of UTUC. He had been receiving intravesical BCG (Bacillus Calmette-Guerin) immunotherapy with a dose of 100mg powder diluted in 60mL of sodium-chloride [saline] which delivered retrograde via a ureteric catheter into the right pelvi-calyceal system at 60mL per hour. After 2 cycles of intra-renal BCG, he presented with right sided abdominal pain associated with jaundice, fever, myalgia and arthralgia. He did not have any tuberculosis contacts. Upon admission, his laboratory parameters were normal, and liver function test showed mixed obstructive and hepatitic picture. Subsequent CT scan of kidneys, ureters and bladder (KUB) showed mild diffuse dilatation of the right ureter and renal pelvis with minimal amount of peri-ureteric fat stranding. A CT scan of the abdomen showed a distended right ureter down to the vesicoureteric junction, peri-ureteric fat stranding and lymphadenopathy in the aorto-caval space together with splenomegaly and atelectatic changes.

The man started receiving treatment with piperacillin-tazobactam. His febrile temperature spikes persisted. No growth was initially detected on blood cultures. Later, he exhibited shortness of breath and respiratory alkalosis. Subsequent CT pulmonary angiography showed dependent bilateral changes in the lower lobes and signs of mild pulmonary venous congestion. He started receiving empirical treatments with hydrocortisone, pyridoxine, ethambutol and rifampicin for BCGosis. Hydrocortisone was eventually tapered down to prednisolone. Virology tests including hepatitis and immunodeficiency virus were negative. His febrile temperature spikes remained persisted. A repeat CT abdomen scan showed similar results like previous scan. An echocardiogram ruled out infective endocarditis. At the same time, he was contact with a COVID-19 positive patient; however, he did not develop COVID-19 infection. Due to persisting shortness of breath, CT pulmonary angiography was performed which showed only mosaic attenuation in the lungs. He also developed pancytopaenia. The lowest white cell count, platelet count and haemoglobin count was 1.51 × 10 ⁹/L, 6 × 10 ⁹/L and 7.8 g/dL, respectively. Three units of platelets were transfused to maintain platelet levels above 10 × 10 ⁹/L. Subsequent bone marrow biopsy did not show mycobacterial growth. After 3 weeks of submission of blood cultures to the lab, Mycobacterium bovis was cultured and the anti-tuberculosis medications were continued. After 34 days of hospitalisation, he was discharged. Prednisolone was tailored down. His ethambutol therapy was continued for a total of 2 months, and isoniazid and pyridoxine were continued for a total of 6 months. No further complications were reported.