Moxifloxacin Versus Ceftriaxone in the Treatment of Primary Pyogenic Liver Abscess

Study Overview
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Brief Summary
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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.

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

Conditions
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Liver Abscess

Intervention / Treatment
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* Drug: Moxifloxacin (Avelox)
* Drug: ceftriaxone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A: Moxifloxacin<br>Moxifloxacin 400mg IV once daily for 14 days, then 400mg PO once daily for 7 days. | Drug: Moxifloxacin (Avelox)<br>* moxifloxacin 400 mg IV qd for 14 days, followed by moxifloxacin 400 mg po qd for another 1 week<br>* Other names: Avelox;|
| Active Comparator: B: Ceftriaxone<br>Ceftriaxone 2gm IV every 12 hours for 14 days, then cephalexin 1gm PO every 6 hours for 7 days. | Drug: ceftriaxone<br>* ceftriaxone 2 gm IV q 12 h for 14 days, followed by cephalexin 1 gm PO q 6 h for 1 week<br>* Other names: Cefin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment efficacy |  | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response |  | Day 3, 7 and 14 | 
| Clinical and radiological response |  | 21 days | 
| All cause mortality |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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liver abscess, moxifloxacin, ceftriaxone, treatment