check_circleStudy Completed

Drug-Induced Liver Injury

Bayer Identifier:

14705

ClinicalTrials.gov Identifier:

NCT01434173

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.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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


  • - 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
July 2001 - March 2009
Phase
N/A
Could I Receive a placebo
No
Products
Avelox (Moxifloxacin hydrochloride, BAY12-8039)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
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 nonuse
    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_encryption
    Safety Issue:
    Yes
  • 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 nonuse
    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_encryption
    Safety Issue:
    Yes

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_encryption
    Safety Issue:
    Yes
  • 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_encryption
    Safety Issue:
    Yes
  • 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 antimicrobials
    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_encryption
    Safety Issue:
    Yes

Trial design

Risk of Acute Liver Injury in Users of Antimicrobials in the HealthCore Integrated Research Database Population
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to Bayer Healthcare products.