Moxifloxacin Versus Ceftriaxone in the Treatment of Primary Pyogenic Liver Abscess

Phase 4

Completed

• Conditions: Liver Abscess
• Interventions: Drug: Moxifloxacin (Avelox); Drug: ceftriaxone

• Registration Number: NCT00895089
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-05-06
• Study First Submitted QC: 2009-05-06
• Study First Posted: 2009-05-07
• Primary Completion: 2010-12
• Study Completion: 2011-12
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-01
• Last Update Posted: 2015-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A: Moxifloxacin	Moxifloxacin (Avelox)	Moxifloxacin 400mg IV once daily for 14 days, then 400mg PO once daily for 7 days.
B: Ceftriaxone	ceftriaxone	Ceftriaxone 2gm IV every 12 hours for 14 days, then cephalexin 1gm PO every 6 hours for 7 days.

Primary Outcome Measures

Name	Time	Method
Treatment efficacy	21 days

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Kaohsiung Veterans General Hospital; 🇨🇳 Kaohsiung, Taiwan