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Moxifloxacin Versus Ceftriaxone in the Treatment of Primary Pyogenic Liver Abscess

Information source: Kaohsiung Veterans General Hospital.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Liver Abscess

Intervention: Moxifloxacin (Avelox) (Drug); ceftriaxone (Rocephin/Cefin) (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Kaohsiung Veterans General Hospital.

Official(s) and/or principal investigator(s):
Susan Shin-Jung Lee, M.D., M.Sc, Principal Investigator, Affiliation: Kaohsiung Veterans General Hospital.

Overall contact:
Susan Shin-Jung Lee, M.D., M.Sc., Phone: +886968971300, Email: ssjlee28@yahoo.com.tw

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Treatment efficacy

Secondary outcome:

Clinical response

Clinical and radiological response

All cause mortality

Mortality attributable to liver abscess during treatment

Rates of complication (metastatic infections to the central nervous system and/or eyes)

Rates of gastrointestinal colonization of Klebsiella pneumoniae in patients and rates of resistance post-antibiotic use.

Eligibility

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Susan Shin-Jung Lee, M.D., M.Sc., Phone: +886968971300, Email: ssjlee28@yahoo.com.tw

Kaohsiung Veterans General Hospital, Kaohsiung 813, Taiwan; Recruiting
Susan Shin-Jung Lee, M.D., M.Sc., Phone: +886-968971300, Email: ssjlee28@yahoo.com.tw
Kelly Yen-Yun Ni, R.N., Phone: +886-73422121, Ext: 2029, Email: ni0630b@yahoo.com.tw
Susan Shin-Jung Lee, M.D., M.Sc., Principal 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., Sub-Investigator
Additional Information

Related publications:

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Tsai FC, Huang YT, Chang LY, Wang JT. Pyogenic liver abscess as endemic disease, Taiwan. Emerg Infect Dis. 2008 Oct;14(10):1592-600. doi: 10.3201/eid1410.071254.

Liu YC, Cheng DL, Lin CL. Klebsiella pneumoniae liver abscess associated with septic endophthalmitis. Arch Intern Med. 1986 Oct;146(10):1913-6.

Chang FY, Chou MY. Comparison of pyogenic liver abscesses caused by Klebsiella pneumoniae and non-K. pneumoniae pathogens. J Formos Med Assoc. 1995 May;94(5):232-7.

Yu WL, Chan KS, Ko WC, Lee CC, Chuang YC. Lower prevalence of diabetes mellitus in patients with Klebsiella pneumoniae primary liver abscess caused by isolates of K1/K2 than with non-K1/K2 capsular serotypes. Clin Infect Dis. 2007 Dec 1;45(11):1529-30; author reply 1532-3.

Chung DR, Lee SS, Lee HR, Kim HB, Choi HJ, Eom JS, Kim JS, Choi YH, Lee JS, Chung MH, Kim YS, Lee H, Lee MS, Park CK; Korean Study Group for Liver Abscess. Emerging invasive liver abscess caused by K1 serotype Klebsiella pneumoniae in Korea. J Infect. 2007 Jun;54(6):578-83. Epub 2006 Dec 18.

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Starting date: May 2009
Last updated: June 22, 2011

Page last updated: August 23, 2015

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