Trial Condition(s):

Drug-Induced Liver Injury

Risk of Acute Liver Injury in Users of Antimicrobials

Bayer Identifier:

14705

ClinicalTrials.gov Identifier:

NCT01434173

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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

Trial Summary

Enrollment Goal
1299056
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
Avelox (Moxifloxacin hydrochloride, BAY12-8039)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, United States

Status
Completed
 

Trial Design