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NCT01434173 · ClinicalTrials.gov registry record
Risk of Acute Liver Injury in Users of Antimicrobials
A clinical trial, sponsored by Bayer.
- Completed
- Registry status
- 1,299,056
- Enrollment target
NCT01434173 is a clinical trial that has completed, run by Bayer. The registered enrollment target is 1,299,056 participants.
The verdict
NCT01434173 has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- 1,299,056 participants
- Enrollment target
Study 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.
Interventions
- DRUG Moxifloxacin (Avelox, BAY12-8039)
- DRUG Amoxicillin, Amoxicillin plus clavulanic acid, Cefuroxime, Clarithromycin, Doxycycline, Levofloxacin, Telithromycin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,299,056 participants |
| Start Date | 2001-07 |
| Est. Completion | 2009-03 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01434173
The ClinicalTrials.gov registry entry for NCT01434173 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 1,299,056 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Moxifloxacin (Avelox, BAY12-8039) is the first listed.
NCT01434173 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01434173 about?
NCT01434173 is a clinical study titled "Risk of Acute Liver Injury in Users of Antimicrobials". 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 reaction...
What is the current status of trial NCT01434173?
This trial is currently completed. The enrollment target is 1,299,056 participants. The study started on 2001-07. Estimated completion is 2009-03.
What interventions are being tested in trial NCT01434173?
The interventions under investigation include: Moxifloxacin (Avelox, BAY12-8039) (DRUG), Amoxicillin, Amoxicillin plus clavulanic acid, Cefuroxime, Clarithromycin, Doxycycline, Levofloxacin, Telithromycin (DRUG).
Who is sponsoring clinical trial NCT01434173?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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