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Moxifloxacin Versus Ceftriaxone in the Treatment of Primary Pyogenic Liver Abscess

Primary Purpose

Liver Abscess

Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Moxifloxacin (Avelox)
ceftriaxone
Sponsored by
Kaohsiung Veterans General Hospital.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Abscess focused on measuring liver abscess, moxifloxacin, ceftriaxone, treatment

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Kaohsiung Veterans General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A: Moxifloxacin

B: Ceftriaxone

Arm Description

Moxifloxacin 400mg IV once daily for 14 days, then 400mg PO once daily for 7 days.

Ceftriaxone 2gm IV every 12 hours for 14 days, then cephalexin 1gm PO every 6 hours for 7 days.

Outcomes

Primary Outcome Measures

Treatment efficacy

Secondary Outcome Measures

Clinical response
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.

Full Information

First Posted
May 6, 2009
Last Updated
December 1, 2015
Sponsor
Kaohsiung Veterans General Hospital.
Collaborators
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT00895089
Brief Title
Moxifloxacin Versus Ceftriaxone in the Treatment of Primary Pyogenic Liver Abscess
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 Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kaohsiung Veterans General Hospital.
Collaborators
Bayer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Abscess
Keywords
liver abscess, moxifloxacin, ceftriaxone, treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A: Moxifloxacin
Arm Type
Experimental
Arm Description
Moxifloxacin 400mg IV once daily for 14 days, then 400mg PO once daily for 7 days.
Arm Title
B: Ceftriaxone
Arm Type
Active Comparator
Arm Description
Ceftriaxone 2gm IV every 12 hours for 14 days, then cephalexin 1gm PO every 6 hours for 7 days.
Intervention Type
Drug
Intervention Name(s)
Moxifloxacin (Avelox)
Other Intervention Name(s)
Avelox
Intervention Description
moxifloxacin 400 mg IV qd for 14 days, followed by moxifloxacin 400 mg po qd for another 1 week
Intervention Type
Drug
Intervention Name(s)
ceftriaxone
Other Intervention Name(s)
Rocephin, Cefin
Intervention Description
ceftriaxone 2 gm IV q 12 h for 14 days, followed by cephalexin 1 gm PO q 6 h for 1 week
Primary Outcome Measure Information:
Title
Treatment efficacy
Time Frame
21 days
Secondary Outcome Measure Information:
Title
Clinical response
Time Frame
Day 3, 7 and 14
Title
Clinical and radiological response
Time Frame
21 days
Title
All cause mortality
Time Frame
21 days
Title
Mortality attributable to liver abscess during treatment
Time Frame
21 days
Title
Rates of complication (metastatic infections to the central nervous system and/or eyes)
Time Frame
21 days
Title
Rates of gastrointestinal colonization of Klebsiella pneumoniae in patients and rates of resistance post-antibiotic use.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Shin-Jung Lee, M.D., M.Sc
Organizational Affiliation
Kaohsiung Veterans General Hospital.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaohsiung Veterans General Hospital
City
Kaohsiung
ZIP/Postal Code
813
Country
Taiwan

12. IPD Sharing Statement

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Moxifloxacin Versus Ceftriaxone in the Treatment of Primary Pyogenic Liver Abscess

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