Status:
COMPLETED
Risk of Acute Liver Injury in Users of Antimicrobials
Lead Sponsor:
Bayer
Collaborating Sponsors:
RTI Health Solutions
Conditions:
Drug-Induced Liver Injury
Eligibility:
All Genders
18+ years
Brief 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 t...
Detailed Description
Study design is called 'Cohort study with nested case-control analysis"
Eligibility Criteria
Inclusion
- 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
- Pregnant women
- Patients with chronic alcoholism or cirrhosis
- Patients with history of acute and/or chronic infectious hepatitis or HIV/AIDS
Key Trial Info
Start Date :
July 1 2001
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
1299056 Patients enrolled
Trial Details
Trial ID
NCT01434173
Start Date
July 1 2001
End Date
March 1 2009
Last Update
July 8 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Many Locations, Delaware, United States