Safety and tolerability of moxifloxacin for the treatment of disseminated BCGitis in children

BACKGROUND AND OBJECTIVE: Disseminated BCGitis is a rare but serious complication of BCG vaccine in patients with underlying primary immunodeficiency. Fluoroquinolone antibiotics containing antimycobacterial regimen have been considered in the treatment of disseminated BCGitis, but there are limited data about the dosing, safety, and tolerability of fluoroquinolone such as moxifloxacin in children. The aim of this study was to report the experience with the dosing, safety, and tolerability of moxifloxacin in children with disseminated BCGitis. METHOD: This retrospective descriptive study included children who had been diagnosed with disseminated BCGitis and treated with an antimycobacterial regimen including moxifloxacin for more than two weeks from 2007 to 2017 at King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia. RESULT: Ten children were included: six (60.0%) were male and four (40.0%) were female. The primary diagnosis for five patients was Mendelian susceptibility to mycobacterial diseases (MSMD), four patients were diagnosed with severe combined immune deficiency (SCID), and the remaining patient had human immunodeficiency virus (HIV) infection. The overall mean duration of moxifloxacin treatment was 10.1 months. Liver toxicity was recorded in three patients. The most common medications used with moxifloxacin were ethambutol and clarithromycin. Moxifloxacin serum concentration level was determined in 5 patients. No musculoskeletal side effects were reported while the patient was on moxifloxacin. The treated patients showed a different response to an antimycobacterial regimen including moxifloxacin, with mortality in two patients. CONCLUSION: Our study suggests that moxifloxacin is generally tolerated in children and might be considered in disseminated BCGitis cases. Additionally, paying attention to side effects such as liver toxicity is recommended, particularly with the use of other antimycobacterial antibiotics, which could also be hepatotoxic. A moxifloxacin-containing regimen for disseminated BCGitis showed clinical improvement in some patients in this study, although the majority presented the same clinical condition.