Moxifloxacin Versus Ceftriaxone in the Treatment of Primary Pyogenic Liver Abscess

Liver Abscess Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00895089
• Other study ID #: VGHKS98-CT2-20
• Status: Completed
• Phase: Phase 4
• First received: May 6, 2009
• Last updated: December 1, 2015
• Start date: May 2009
• Est. completion date: December 2011

Study information

• Verified date: December 2015
• Source: Kaohsiung Veterans General Hospital.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Abscess
• Liver Abscess
• Liver Abscess, Pyogenic

Intervention

Drug:
• Moxifloxacin (Avelox)
moxifloxacin 400 mg IV qd for 14 days, followed by moxifloxacin 400 mg po qd for another 1 week
• ceftriaxone
ceftriaxone 2 gm IV q 12 h for 14 days, followed by cephalexin 1 gm PO q 6 h for 1 week

Locations

Country	Name	City	State
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung

Sponsors (2)

Lead Sponsor	Collaborator
Kaohsiung Veterans General Hospital.	Bayer

Country where clinical trial is conducted

Taiwan, 

References & Publications (27)

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Chang SC, Fang CT, Hsueh PR, Chen YC, Luh KT. Klebsiella pneumoniae isolates causing liver abscess in Taiwan. Diagn Microbiol Infect Dis. 2000 Aug;37(4):279-84. — View Citation

Chen YW, Chen YS, Lee SS, Yen MY, Wann SR, Lin HH, Huang WK, Liu YC. A pilot study of oral fleroxacin once daily compared with conventional therapy in patients with pyogenic liver abscess. J Microbiol Immunol Infect. 2002 Sep;35(3):179-83. — View Citation

Cheng HP, Siu LK, Chang FY. Extended-spectrum cephalosporin compared to cefazolin for treatment of Klebsiella pneumoniae-caused liver abscess. Antimicrob Agents Chemother. 2003 Jul;47(7):2088-92. — View Citation

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. — View Citation

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Edmiston CE, Krepel CJ, Seabrook GR, Somberg LR, Nakeeb A, Cambria RA, Towne JB. In vitro activities of moxifloxacin against 900 aerobic and anaerobic surgical isolates from patients with intra-abdominal and diabetic foot infections. Antimicrob Agents Chemother. 2004 Mar;48(3):1012-6. — View Citation

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Tan YM, Chee SP, Soo KC, Chow P. Ocular manifestations and complications of pyogenic liver abscess. World J Surg. 2004 Jan;28(1):38-42. Epub 2003 Nov 14. — View Citation

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. — View Citation

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Wang JH, Liu YC, Lee SS, Yen MY, Chen YS, Wang JH, Wann SR, Lin HH. Primary liver abscess due to Klebsiella pneumoniae in Taiwan. Clin Infect Dis. 1998 Jun;26(6):1434-8. — View Citation

Wiwanitkit V. Causative agents of liver abscess in HIV-seropositive patients: a 10-year case series in Thai hospitalized patients. Trop Doct. 2005 Apr;35(2):115-7. — View Citation

Yeoh KG, Yap I, Wong ST, Wee A, Guan R, Kang JY. Tropical liver abscess. Postgrad Med J. 1997 Feb;73(856):89-92. — View Citation

Yu SC, Ho SS, Lau WY, Yeung DT, Yuen EH, Lee PS, Metreweli C. Treatment of pyogenic liver abscess: prospective randomized comparison of catheter drainage and needle aspiration. Hepatology. 2004 Apr;39(4):932-8. — View Citation

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. — View Citation

Zerem E, Hadzic A. Sonographically guided percutaneous catheter drainage versus needle aspiration in the management of pyogenic liver abscess. AJR Am J Roentgenol. 2007 Sep;189(3):W138-42. — View Citation

* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment efficacy		21 days	No
Secondary	Clinical response		Day 3, 7 and 14	No
Secondary	Clinical and radiological response		21 days	No
Secondary	All cause mortality		21 days	Yes
Secondary	Mortality attributable to liver abscess during treatment		21 days	No
Secondary	Rates of complication (metastatic infections to the central nervous system and/or eyes)		21 days	No
Secondary	Rates of gastrointestinal colonization of Klebsiella pneumoniae in patients and rates of resistance post-antibiotic use.		3 months	No