Risk of Acute Liver Injury in Users of Antimicrobials

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Collaborator: RTI Health Solutions
• Treatments: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Infective Agents; Cefuroxime; Cefuroxime axetil; Clarithromycin; Clavulanic Acid; Clavulanic Acids; Doxycycline; Levofloxacin; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination; Ofloxacin; Telithromycin

Criteria

Inclusion Criteria:

• All persons meeting the following criteria during the study period (July 1, 2001, through March 31, 2009) are eligible for study inclusion:

• First insurance claim for a dispensing of one of the study antimicrobials during the study period ("new users")

• Aged 18 years old or older

• Continuous enrollment in the study database for at least 6 months prior to start of follow-up (which is the date of the first claim for any of the study antimicrobials)

• Patient data defined as acceptable for research purposes according to the quality criteria of the HIRD

Exclusion Criteria:

• Pregnant women

• Patients with chronic alcoholism or cirrhosis

• Patients with history of acute and/or chronic infectious hepatitis or HIV/AIDS