Moxifloxacin Versus Ceftriaxone in the Treatment of Primary Pyogenic Liver Abscess

December 1, 2015 updated by: Susan Shin-Jung Lee, Kaohsiung Veterans General Hospital.

Prospective, Randomized, Open-Labeled, Active-Controlled Comparison of Moxifloxacin Versus Ceftriaxone in the Treatment of Primary Pyogenic Liver Abscess: A Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 813
        • Kaohsiung Veterans General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Treatment efficacy
Time Frame: 21 days
21 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaohsiung Veterans General Hospital.

Collaborators

Bayer

Investigators

  • Principal Investigator: Susan Shin-Jung Lee, M.D., M.Sc, Kaohsiung Veterans General Hospital.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

May 6, 2009

First Submitted That Met QC Criteria

May 6, 2009

First Posted (Estimate)

May 7, 2009

Study Record Updates

Last Update Posted (Estimate)

December 2, 2015

Last Update Submitted That Met QC Criteria

December 1, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VGHKS98-CT2-20

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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