check_circleStudy Completed
Drug-Induced Liver Injury
Bayer Identifier:
14705
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Risk of Acute Liver Injury in Users of Antimicrobials
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.
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.
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
1299056Trial Dates
July 2001 - March 2009Phase
N/ACould I Receive a placebo
NoProducts
Avelox (Moxifloxacin hydrochloride, BAY12-8039)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations, United States |
Primary Outcome
- Incidence ratio of noninfectious acute liver injury fulfilling the International Consensus Meeting criteria for drug-induced liver disorders in the study population during periods of treatment with each of the study antimicrobials and nonusedate_rangeTime Frame:From the first day of full exposure of a study antimicrobial (day after the date of dispensing) to the end of follow-up (up to 8 years)enhanced_encryptionYesSafety Issue:
- Incidence rate ratio of noninfectious acute liver injury fulfilling the International Consensus Meeting criteria for drug-induced liver disorders during treatment with each of the study antimicrobials compared to that during of nonusedate_rangeTime Frame:From the first day of full exposure of a study antimicrobial (day after the date of dispensing) to the end of follow-up (up to 8 years)enhanced_encryptionYesSafety Issue:
Secondary Outcome
- Incidence rate and incidence rate ratio of noninfectious severe hepatocellular injury as defined by the Hy’s Law criteria modified by the FDA Working Group (FDA Working group, 2000; Temple, 2006; Navarro and Senior, 2006)date_rangeTime Frame:From the first day of full exposure of a study antimicrobial (day after the date of dispensing) to the end of follow-up (up to 8 years)enhanced_encryptionYesSafety Issue:
- Incidence rate and incidence rate ratio of noninfectious acute liver failure, defined as acute liver injury with evidence of coagulation abnormality and any degree of mental alteration (encephalopathy) (Polson and Lee, 2005)date_rangeTime Frame:From the first day of full exposure of a study antimicrobial (day after the date of dispensing) to the end of follow-up (up to 8 years)enhanced_encryptionYesSafety Issue:
- Cumulative incidence of noninfections acute liver injury, noninfectious severe hepatocellular injury, and noninfectious acute liver failure at weekly intervals after the start of first episode of treatment with each of the study antimicrobialsdate_rangeTime Frame:From the first day of full exposure of a study antimicrobial (day after the date of dispensing) to the end of follow-up (up to 8 years)enhanced_encryptionYesSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A