Risk of Acute Liver Injury in Users of Antimicrobials

CompletedOBSERVATIONAL
Enrollment

1,299,056

Participants

Timeline

Start Date

July 31, 2001

Primary Completion Date

March 31, 2009

Study Completion Date

March 31, 2009

Conditions
Drug-Induced Liver Injury
Interventions
DRUG

Moxifloxacin (Avelox, BAY12-8039)

Eligible patients who are new users of moxifloxacin during the study period. A new user is defined as a person who has a first recorded dispensing of moxifloxacin during the study period and who has not had a previous recorded dispensing for any of the study antimicrobials during the previous 180 days

DRUG

Amoxicillin, Amoxicillin plus clavulanic acid, Cefuroxime, Clarithromycin, Doxycycline, Levofloxacin, Telithromycin

Eligible patients who are new users of one of the other study antimicrobials (amoxicillin, amoxicillin plus clavulanic acid, cefuroxime, clarithromycin, doxycycline, levofloxacin, or telithromycin) during the study period. A new user is defined as a person who has a first recorded dispensing of a study a study antimicrobial during the study period and who has not had a previous recorded dispensing for any of the study antimicrobials during the previous 180 days.

Trial Locations (1)

Unknown

Many Locations

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

RTI Health Solutions

OTHER

lead

Bayer

INDUSTRY