Risk of Acute Liver Injury in Users of Antimicrobials

Status Completed

Clinical Trial 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 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.

Clinical Trial Description

Study design is called 'Cohort study with nested case-control analysis" ;

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Drug-Induced Liver Injury

Clinical Trial Details

NCT number	NCT01434173
Study type	Observational
Source	Bayer
Contact
Status	Completed
Phase	N/A
Start date	July 2001
Completion date	March 2009

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05517668` - Evaluation of the Efficacy of Fomepizole in the Treatment of Acetaminophen Overdose	Phase 2
Recruiting	`NCT05060289` - A Prognostic Model for Drug-induced Liver Injury in China
Completed	`NCT03092817` - Adjunctive Corticosteroids for Tuberculous Meningitis in HIV-infected Adults (The ACT HIV Trial)	Phase 3
Completed	`NCT03211208` - Assessing Antibiotic Induced Liver Injury for Stratification of Tuberculosis Patients
Completed	`NCT02182167` - A Trial Of Intravenous N-Acetylcysteine In The Management Of Antituberculous Drug-Induced Hepatitis	Phase 2/Phase 3
Not yet recruiting	`NCT02061826` - Establishment of Drug-induced Liver Injury Databases and Application of Circulating microRNA(miRNA)	N/A
Completed	`NCT03665402` - A Pharamcogenomic Study for Isoniazid According to NAT2 Polymorphism Status	N/A
Not yet recruiting	`NCT03091244` - Surveillance for Early Liver Injuries Caused by Xianlin Gubao Capsule.	N/A
Not yet recruiting	`NCT03091218` - Surveillance for Early Liver Injuries Caused by Runzao Zhiyang Capsule.	N/A
Not yet recruiting	`NCT03060252` - Surveillance for Early Liver Injuries Caused by Zhuanggu Guanjie Pill	N/A
Not yet recruiting	`NCT03091608` - Surveillance for Early Liver Injuries Caused by Xianlin Gubao Granule	N/A
Not yet recruiting	`NCT03091556` - Surveillance for Early Liver Injuries Caused by Xianlin Gubao Pill.	N/A
Completed	`NCT02407964` - A Retrospective Study on Drug Induced Liver Injury in China	N/A
Active, not recruiting	`NCT05144217` - Impact of Silymarin Dosages to Decrease Drug-induced Elevated Liver Enzymes Compared to Placebo	Phase 2/Phase 3
Completed	`NCT01705041` - Preliminary Evaluation of a Point-Of-Care Liver Function Test	N/A
Recruiting	`NCT02086708` - Ultrasound Method to Measure Fibrosis of the Liver in Children	N/A
Recruiting	`NCT05465642` - Alterations of Gut Microbiota and Serum Biochemical Markers in DILI Patients
Completed	`NCT05532345` - Discrimination of DILI and AIH by Artificial Intelligence
Completed	`NCT03602703` - Immune Responses in Hepatocellular Carcinoma Patients After Treatment With Direct Acting Antiviral Drugs
Active, not recruiting	`NCT03100786` - Leukotriene A4 Hydrolase Stratified Trial of Adjunctive Corticosteroids for HIV-uninfected Adults With Tuberculous Meningitis	Phase 3