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Liver Abscess | Moxifloxacin Versus Ceftriaxone in the Treatment of Primary Pyogenic Liver Abscess

Liver Abscess research study

What is the primary objective of this 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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Liver Abscess

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Moxifloxacin (Avelox)moxifloxacin 400 mg IV qd for 14 days, followed by moxifloxacin 400 mg po qd for another 1 week

Drug:ceftriaxoneceftriaxone 2 gm IV q 12 h for 14 days, followed by cephalexin 1 gm PO q 6 h for 1 week

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

A: MoxifloxacinMoxifloxacin 400mg IV once daily for 14 days, then 400mg PO once daily for 7 days.

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

Study Status

Completed

Start Date: May 2009

Completed Date: December 2011

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Treatment efficacy

Secondary Outcome: Clinical response

Study sponsors, principal investigator, and references

Principal Investigator: Susan Shin-Jung Lee, M.D., M.Sc

Lead Sponsor: Kaohsiung Veterans General Hospital.

Collaborator: Bayer

More information:https://clinicaltrials.gov/show/NCT00895089

Lee SS, Chen YS, Tsai HC, Wann SR, Lin HH, Huang CK, Liu YC. Predictors of septic metastatic infection and mortality among patients with Klebsiella pneumoniae liver abscess. Clin Infect Dis. 2008 Sep 1;47(5):642-50. doi: 10.1086/590932.

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