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 75-year-old man developed cytomegalovirus proctitis following reactivation of cytomegalovirus infection following immunosuppressant drug therapy with dexamethasone for COVID-19 pneumonia.

The man, who was overweigh and had uncomplicated well-controlled type 2 diabetes, was diagnosed with severe COVID-19 pneumonia. He therefore admitted. Upon admission, routine blood tests showed an inflammatory syndrome with elevated CRP and neutrophilia with global lymphopenia. He started receiving a 10-day course of off-label treatment with IV dexamethasone 20 mg/day scheduled to be administered for 5 days, followed by 10 mg/day for the further 5 days for the COVID-19 pneumonia. He concomitantly received ceftriaxone and spiramycin for a suspected bacterial super-infection. Four days following initiation of dexamethasone and antimicrobial treatment, his condition was found to be worsened. A 10-day course of off-label treatment with oral lopinavir/ritonavir 400mg twice a day and a 5-day course of off-label SC anakinra 100 mg/day were added to his treatment for the COVID-19 pneumonia. Thereafter, a progressive improvement was noted in his respiratory state with apyrexia and decrease of oxygen requirement. One week later, he developed fever and acute non-bloody diarrhea. An abdominal iodinated contrast agent-enhanced CT scan showed a circumferential thickening of the rectal wall, with peri-rectal fat infiltration and enhancement of rectal mucosa, which was consistent with uncomplicated proctitis. Repeated stool cultures were negative for bacteria and parasites. A fecal multiplex PCR and Clostridioides difficile infection studies were also negative. Subsequently, the diarrhoea worsened, and he was shifted to ICU due to hypovolaemic shock. A colonoscopy revealed multiple uncomplicated diverticula in the sigmoid colon and a circumferential mass of the lower and medial parts of the rectum, which was biopsied. Pathologic examination of the biopsied tissue showed an ulcerated rectal mucosa and a cytopathogenic effect with ballooned cells and cytomegalovirus inclusions. Specific immunohistochemistry staining with an anti-CMV antibody showed positive result on rectal biopsy. Blood cytomegalovirus specific PCR was positive. Two serologies 15-days apart showed stable positive IgG with negative IgM. A diagnosis of proctitis secondary to reactivation of cytomegalovirus infection was thus made.

The man was treated with valganciclovir with a favorable outcome. At the end of valganciclovir treatment, he transited was back to the normal, and remained apyretic. An abdominal CT scan demonstrated complete resolution of the proctitis. Serum cytomegalovirus PCR became undetectable. Due to clinical recovery and the discontinuation of all immunosuppressive agents more than two months before, secondary prophylaxis was not administered. Two months following the completion of the valganciclovir treatment, he underwent a rectosigmoidoscopy.