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Moxifloxacin Versus Ceftriaxone in the Treatment of Primary Pyogenic Liver Abscess

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00895089
Recruitment Status : Completed
First Posted : May 7, 2009
Last Update Posted : December 2, 2015
Information provided by (Responsible Party):
Susan Shin-Jung Lee, Kaohsiung Veterans General Hospital.

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 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.

Condition or disease Intervention/treatment Phase
Liver Abscess Drug: Moxifloxacin (Avelox) Drug: ceftriaxone Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : May 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abscess

Arm Intervention/treatment
Experimental: A: Moxifloxacin
Moxifloxacin 400mg IV once daily for 14 days, then 400mg PO once daily for 7 days.
Drug: Moxifloxacin (Avelox)
moxifloxacin 400 mg IV qd for 14 days, followed by moxifloxacin 400 mg po qd for another 1 week
Other Name: Avelox

Active Comparator: B: Ceftriaxone
Ceftriaxone 2gm IV every 12 hours for 14 days, then cephalexin 1gm PO every 6 hours for 7 days.
Drug: ceftriaxone
ceftriaxone 2 gm IV q 12 h for 14 days, followed by cephalexin 1 gm PO q 6 h for 1 week
Other Names:
  • Rocephin
  • Cefin

Primary Outcome Measures :
  1. Treatment efficacy [ Time Frame: 21 days ]

Secondary Outcome Measures :
  1. Clinical response [ Time Frame: Day 3, 7 and 14 ]
  2. Clinical and radiological response [ Time Frame: 21 days ]
  3. All cause mortality [ Time Frame: 21 days ]
  4. Mortality attributable to liver abscess during treatment [ Time Frame: 21 days ]
  5. Rates of complication (metastatic infections to the central nervous system and/or eyes) [ Time Frame: 21 days ]
  6. Rates of gastrointestinal colonization of Klebsiella pneumoniae in patients and rates of resistance post-antibiotic use. [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00895089

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Kaohsiung Veterans General Hospital
Kaohsiung, Taiwan, 813
Sponsors and Collaborators
Kaohsiung Veterans General Hospital.
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Principal Investigator: Susan Shin-Jung Lee, M.D., M.Sc Kaohsiung Veterans General Hospital.


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Responsible Party: Susan Shin-Jung Lee, Attending physician, Kaohsiung Veterans General Hospital. Identifier: NCT00895089     History of Changes
Other Study ID Numbers: VGHKS98-CT2-20
First Posted: May 7, 2009    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: December 2015
Keywords provided by Susan Shin-Jung Lee, Kaohsiung Veterans General Hospital.:
liver abscess
Additional relevant MeSH terms:
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Liver Abscess
Liver Abscess, Pyogenic
Pathologic Processes
Abdominal Abscess
Liver Diseases
Digestive System Diseases
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs