Status:
COMPLETED
Moxifloxacin Versus Ceftriaxone in the Treatment of Primary Pyogenic Liver Abscess
Lead Sponsor:
Kaohsiung Veterans General Hospital.
Collaborating Sponsors:
Bayer
Conditions:
Liver Abscess
Eligibility:
All Genders
20+ years
Phase:
PHASE4
Brief Summary
This clinical trial compares the use of moxifloxacin versus ceftriaxone in the treatment of primary pyogenic liver abscess. The trial will include nonpregnant adults presenting with primary liver absc...
Eligibility Criteria
Inclusion
- Age greater or equal to 20 years.
- Clinical diagnosis of liver abscess, supported by an abdominal CT scan, documenting the presence of liver abscess, in the absence of biliary tract stones (except for gallstones without biliary tract dilatation), biliary tract dilatation and biliary tract tumors. Clinical diagnosis of liver abscess includes symptoms of fever, chills, right upper quadrant abdominal pain or knocking tenderness.
- Read, understood and signed informed consent form.
Exclusion
- Presence of septic metastatic infections to the CNS or eye at presentation.
- Cultures positive for an organism resistant to study drugs.
- APACHE II score greater or equal to 20.
- Co-existent disease considered likely to affect the outcome of the study (e.g., biliary tract stones and malignancy).
- Patients with ruptured liver abscess
- Severe hepatic insufficiency (Child-Pugh C) or elevated serum transaminases (GPT) to greater than 5 times the upper limit of normal.
- Patients who are pregnant or lactating.
- Known hypersensitivity to b-lactams or fluoroquinolones.
- Known prolongation of the QT interval.
- Patients with uncorrected hypokalemia.
- Patients receiving class IA (e.g., quinidine, procainamide) or class III (e.g., amiodarone, sotalol) antiarrhythmic agents
- Severe, life-threatening disease with a life expectancy of less than 2 months.
- Pre-treatment with a systemic antibacterial agent for \> 24 hours prior to enrollment within 5 days prior to enrollment.
- Participated in any clinical investigational drug study within 4 weeks of screening.
- Previously entered in this study.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00895089
Start Date
May 1 2009
End Date
December 1 2011
Last Update
December 2 2015
Active Locations (1)
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1
Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan, 813