Risk of Acute Liver Injury in Users of Antimicrobials
Status:
Completed
Trial end date:
2009-03-01
Target enrollment:
Participant gender:
Summary
Moxifloxacin is a broad-spectrum antibacterial agent used to treat common community-acquired
respiratory tract infections, complicated intra-abdominal infections, and pelvic inflammatory
disease. In the clinical development program, moxifloxacin was associated with some hepatic
adverse drug reactions. To evaluate further the hepatic safety profile of moxifloxacin, a
retrospective cohort study with nested case-control analysis will be conducted to assess the
rate of noninfectious acute liver injury among new users of moxifloxacin and of other
antimicrobials prescribed for similar indications, including amoxicillin, amoxicillin plus
clavulanic acid, cefuroxime, clarithromycin, doxycycline, levofloxacin, and telithromycin.
The study will be implemented in the population included in the HealthCore Integrated
Research Database (HIRD). Eligible patients are adults aged 18 years and older with
continuous enrollment in the HIRD for at least 6 months before their first claim for a
prescription for a study antimicrobial. Follow-up will start at the date of the first
prescription until the date of the earliest of the following events: noninfectious acute
liver injury, occurrence of an exclusion criterion, end of study period, disenrollment from
database, or death. Patients with chronic alcoholism or cirrhosis, infectious hepatitis,
HIV/AIDS, or pregnant women will not be included.