Safety and tolerability of a standardized treatment regimen for Mycobacterium abscessus otomastoiditis

Background: This study aims to evaluate the drug-induced adverse events of our institutional multidisciplinary clinical pathway for M. abscessus treatment and gives suggestions for monitoring and management of adverse events. Methods: Patients treated according to a published institutional clinical pathway in our tertiary referral centre were included. Main outcome measures were the type and frequency of adverse events documented. In addition, reasons for drug cessation or interruption were evaluated. Results: Ten patients were included (mean age: 8 years old; male: 70 %). All patients suffered from adverse events, in 90 % of the cases leading to pre-term drug interruption (40 %) or even cessation (70 %) of one or more antibiotics. Most common adverse events were gastrointestinal (100 %), weight loss (60 %), elevated liver enzymes (70 %), hypoalbuminemia (90 %) and hypertriglyceridemia (70 %). Most adverse events were likely caused by tigecycline. All children were clinically cured after the treatment and did not suffer from long-term physical adverse events. Conclusions: The multidrug treatment for M. abscessus otomastoiditis is frequently complicated by adverse events. Management by a specialized team is recommended. Frequent clinical monitoring, regular blood tests, audiograms and ECGs are recommended. Prophylactic antiemetics should be administered due to the high frequency of nausea and vomiting, particularly with tigecycline.