Moxifloxacin Versus Ceftriaxone in the Treatment of Primary Pyogenic Liver Abscess

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Kaohsiung Veterans General Hospital..
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Bayer
Information provided by:
Kaohsiung Veterans General Hospital.
ClinicalTrials.gov Identifier:
NCT00895089
First received: May 6, 2009
Last updated: June 22, 2011
Last verified: May 2010
  Purpose

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 Intervention Phase
Liver Abscess
Drug: Moxifloxacin (Avelox)
Drug: ceftriaxone (Rocephin/Cefin)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Kaohsiung Veterans General Hospital.:

Primary Outcome Measures:
  • Treatment efficacy [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical response [ Time Frame: Day 3, 7 and 14 ] [ Designated as safety issue: No ]
  • Clinical and radiological response [ Time Frame: 21 days ] [ Designated as safety issue: No ]
  • All cause mortality [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
  • Mortality attributable to liver abscess during treatment [ Time Frame: 21 days ] [ Designated as safety issue: No ]
  • Rates of complication (metastatic infections to the central nervous system and/or eyes) [ Time Frame: 21 days ] [ Designated as safety issue: No ]
  • Rates of gastrointestinal colonization of Klebsiella pneumoniae in patients and rates of resistance post-antibiotic use. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: May 2009
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A: Moxifloxacin
Moxifloxacin 400mg IV QD for 14 days, then 400mg PO QD 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 Q12H for 14 days, then cephalexin 1gm PO q6h for 7 days.
Drug: ceftriaxone (Rocephin/Cefin)
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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00895089

Contacts
Contact: Susan Shin-Jung Lee, M.D., M.Sc. +886968971300 ssjlee28@yahoo.com.tw
Contact: Kelly Yen-Yun Ni, R.N. +88673422121 ext 2029 ni0630b@yahoo.com.tw

Locations
Taiwan
Kaohsiung Veterans General Hospital Recruiting
Kaohsiung, Taiwan, 813
Contact: Susan Shin-Jung Lee, M.D., M.Sc.    +886-968971300    ssjlee28@yahoo.com.tw   
Contact: Kelly Yen-Yun Ni, R.N.    +886-73422121 ext 2029    ni0630b@yahoo.com.tw   
Principal Investigator: Susan Shin-Jung Lee, M.D., M.Sc.         
Sub-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.         
Sponsors and Collaborators
Kaohsiung Veterans General Hospital.
Bayer
Investigators
Principal Investigator: Susan Shin-Jung Lee, M.D., M.Sc Kaohsiung Veterans General Hospital.
  More Information

Publications:

Responsible Party: Attending physician, Kaohsiung Veterans General Hospital
ClinicalTrials.gov Identifier: NCT00895089     History of Changes
Other Study ID Numbers: VGHKS98-CT2-20
Study First Received: May 6, 2009
Last Updated: June 22, 2011
Health Authority: Taiwan: Department of Health

Keywords provided by Kaohsiung Veterans General Hospital.:
liver abscess
moxifloxacin
ceftriaxone
treatment

Additional relevant MeSH terms:
Abscess
Liver Abscess
Liver Abscess, Pyogenic
Suppuration
Infection
Inflammation
Pathologic Processes
Abdominal Abscess
Liver Diseases
Digestive System Diseases
Ceftriaxone
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 20, 2014