Moxifloxacin Versus Ceftriaxone in the Treatment of Primary Pyogenic Liver Abscess
Information source: Kaohsiung Veterans General Hospital.
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Liver Abscess
Intervention: Moxifloxacin (Avelox) (Drug); ceftriaxone (Rocephin/Cefin) (Drug)
Phase: Phase 4
Sponsored by: Kaohsiung Veterans General Hospital.
Official(s) and/or principal investigator(s):
Susan Shin-Jung Lee, M.D., M.Sc, Principal Investigator, Affiliation: Kaohsiung Veterans General Hospital.
Susan Shin-Jung Lee, M.D., M.Sc., Phone: +886968971300, Email: email@example.com
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 abscess based on clinical diagnosis and computed tomography. The trial aims to
determine whether the use of moxifloxacin can effectively treat primary pyogenic liver
abscess and shorten hospitalization. This regimen has the additional benefit of avoiding
nephrotoxic agents, such as aminoglycosides, used frequently in treatment of pyogenic liver
abscess. Development of antibiotic resistance to colonized bacteria in the gastrointestinal
tract will also be evaluated using stool cultures.
Official title: Prospective, Randomized, Open-Labeled, Active-Controlled Comparison of Moxifloxacin Versus Ceftriaxone in the Treatment of Primary Pyogenic Liver Abscess: A Pilot Study
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Treatment efficacy
Clinical and radiological response
All cause mortality
Mortality attributable to liver abscess during treatment
Rates of complication (metastatic infections to the central nervous system and/or eyes)
Rates of gastrointestinal colonization of Klebsiella pneumoniae in patients and rates of resistance post-antibiotic use.
Minimum age: 20 Years.
Maximum age: N/A.
- 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.
- 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.
Locations and Contacts
Susan Shin-Jung Lee, M.D., M.Sc., Phone: +886968971300, Email: firstname.lastname@example.org
Kaohsiung Veterans General Hospital, Kaohsiung 813, Taiwan; Recruiting
Susan Shin-Jung Lee, M.D., M.Sc., Phone: +886-968971300, Email: email@example.com
Kelly Yen-Yun Ni, R.N., Phone: +886-73422121, Ext: 2029, Email: firstname.lastname@example.org
Susan Shin-Jung Lee, M.D., M.Sc., Principal Investigator
Yao-Shen Chen, M.D., Sub-Investigator
Hung-Chin Tsai, M.D., Ph.D., Sub-Investigator
Jui-Kuang Chen, M.D., Sub-Investigator
Cheng-Len Sy, M.D., BSMT, Sub-Investigator
Kuan-Sheng Wu, M.D., Sub-Investigator
Yen-Yun Ni, R.N., Sub-Investigator
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Starting date: May 2009
Last updated: June 22, 2011