Moxifloxacin Versus Ceftriaxone in the Treatment of Primary Pyogenic Liver Abscess - Full Text View

Sponsor:	Kaohsiung Veterans General Hospital.
Collaborator:	Bayer
Information provided by:	Kaohsiung Veterans General Hospital.
ClinicalTrials.gov Identifier:	NCT00895089

Purpose

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.

Condition	Intervention	Phase
Liver Abscess	Drug: moxifloxacin (Avelox) Drug: ceftriaxone (Rocephin/Cefin)	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Prospective, Randomized, Open-Labeled, Active-Controlled Comparison of Moxifloxacin Versus Ceftriaxone in the Treatment of Primary Pyogenic Liver Abscess: A Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics

Drug Information available for: Ceftriaxone Ceftriaxone Sodium Moxifloxacin Moxifloxacin hydrochloride

U.S. FDA Resources

Further study details as provided by Kaohsiung Veterans General Hospital.:

Primary Outcome Measures:

Treatment efficacy [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical response [ Time Frame: Day 3, 7 and 14 ] [ Designated as safety issue: No ]
Clinical and radiological response [ Time Frame: 21 days ] [ Designated as safety issue: No ]
All cause mortality [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
Mortality attributable to liver abscess during treatment [ Time Frame: 21 days ] [ Designated as safety issue: No ]
Rates of complication (metastatic infections to the central nervous system and/or eyes) [ Time Frame: 21 days ] [ Designated as safety issue: No ]
Rates of gastrointestinal colonization of Klebsiella pneumoniae in patients and rates of resistance post-antibiotic use. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	48
Study Start Date:	May 2009
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Moxifloxacin 400mg IV QD for 14 days, then 400mg PO QD for 7 days.	Drug: moxifloxacin (Avelox) moxifloxacin 400 mg IV qd for 14 days, followed by moxifloxacin 400 mg po qd for another 1 week
B: Active Comparator Ceftriaxone 2gm IV Q12H for 14 days, then cephalexin 1gm PO q6h for 7 days.	Drug: ceftriaxone (Rocephin/Cefin) ceftriaxone 2 gm IV q 12 h for 14 days, followed by cephalexin 1 gm PO q 6 h for 1 week

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age greater or equal to 18 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).
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00895089

Contacts

Contact: Susan Shin-Jung Lee, M.D., M.Sc.	+886968971300	ssjlee28@yahoo.com.tw
Contact: Kelly Yen-Yun Ni, R.N.	+88673422121 ext 2029	ni0630b@yahoo.com.tw

Locations

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

Sponsors and Collaborators

Kaohsiung Veterans General Hospital.

Bayer

Investigators

Principal Investigator:

Susan Shin-Jung Lee, M.D., M.Sc

Kaohsiung Veterans General Hospital.

More Information

Publications:

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.

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

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. No abstract available.

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.

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.

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

Okano H, Shiraki K, Inoue H, Kawakita T, Yamamoto N, Deguchi M, Sugimoto K, Sakai T, Ohmori S, Murata K, Nakano T. Clinicopathological analysis of liver abscess in Japan. Int J Mol Med. 2002 Nov;10(5):627-30.

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.

Lederman ER, Crum NF. Pyogenic liver abscess with a focus on Klebsiella pneumoniae as a primary pathogen: an emerging disease with unique clinical characteristics. Am J Gastroenterol. 2005 Feb;100(2):322-31. Review.

Nadasy KA, Domiati-Saad R, Tribble MA. Invasive Klebsiella pneumoniae syndrome in North America. Clin Infect Dis. 2007 Aug 1;45(3):e25-8. Epub 2007 Jun 18.

Keynan Y, Karlowsky JA, Walus T, Rubinstein E. Pyogenic liver abscess caused by hypermucoviscous Klebsiella pneumoniae. Scand J Infect Dis. 2007;39(9):828-30.

Karama EM, Willermain F, Janssens X, Claus M, Van den Wijngaert S, Wang JT, Verougstraete C, Caspers L. Endogenous endophthalmitis complicating Klebsiella pneumoniae liver abscess in Europe: case report. Int Ophthalmol. 2008 Apr;28(2):111-3. Epub 2007 Aug 1.

Rahimian J, Wilson T, Oram V, Holzman RS. Pyogenic liver abscess: recent trends in etiology and mortality. Clin Infect Dis. 2004 Dec 1;39(11):1654-9. Epub 2004 Nov 9.

Harris PJ, Laczek JT, Polish RD, Fraser SL. Two cases of Klebsiella pneumoniae primary liver abscesses; an emerging clinical entity among diabetics. Hawaii Med J. 2005 Dec;64(12):306-7, 325.

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.

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.

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.

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.

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.

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.

Sheng WH, Wang JT, Chen YC, Chang SC, Luh KT. In vitro activity of moxifloxacin against common clinical bacterial isolates in Taiwan. J Microbiol Immunol Infect. 2001 Sep;34(3):178-84.

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.

Paterson DL. "Collateral damage" from cephalosporin or quinolone antibiotic therapy. Clin Infect Dis. 2004 May 15;38 Suppl 4:S341-5.

Van Saene JJ, Van Saene HK, Geitz JN, Tarko-Smit NJ, Lerk CF. Quinolones and colonization resistance in human volunteers. Pharm Weekbl Sci. 1986 Feb 21;8(1):67-71.

de Vries-Hospers HG, Welling GW, van der Waaij D. Influence of quinolones on throat- and faecal flora of healthy volunteers. Pharm Weekbl Sci. 1987 Dec 11;9 Suppl:S41-4.

Responsible Party:	Kaohsiung Veterans General Hospital ( Attending physician )
Study ID Numbers:	VGHKS98-CT2-20
Study First Received:	May 6, 2009
Last Updated:	November 2, 2009
ClinicalTrials.gov Identifier:	NCT00895089 History of Changes
Health Authority:	Taiwan: Department of Health

Keywords provided by Kaohsiung Veterans General Hospital.:

liver abscess
moxifloxacin
ceftriaxone
treatment

Additional relevant MeSH terms:

Anti-Infective Agents
Abdominal Abscess
Liver Diseases
Ceftriaxone
Infection
Pharmacologic Actions
Inflammation
Anti-Bacterial Agents

Pathologic Processes
Digestive System Diseases
Liver Abscess
Moxifloxacin
Therapeutic Uses
Abscess
Liver Abscess, Pyogenic
Suppuration

ClinicalTrials.gov processed this record on February 08, 2010