Moxifloxacin Versus Ceftriaxone in the Treatment of Primary Pyogenic Liver Abscess

NCT00895089 | Completed Phase 4

• 1 other identifier: VGHKS98-CT2-20
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Liver Abscess

Keywords

liver abscess; moxifloxacin; ceftriaxone; treatment

Outcome Measures

Primary Outcomes (1)

• Treatment efficacy

  21 days

Secondary Outcomes (6)

• 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

Study Arms (2)

A: Moxifloxacin

EXPERIMENTAL

Moxifloxacin 400mg IV once daily for 14 days, then 400mg PO once daily for 7 days.

Drug: Moxifloxacin (Avelox)

B: Ceftriaxone

ACTIVE COMPARATOR

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

Drug: ceftriaxone

Interventions

Moxifloxacin (Avelox) DRUG

moxifloxacin 400 mg IV qd for 14 days, followed by moxifloxacin 400 mg po qd for another 1 week

Also known as: Avelox

A: Moxifloxacin

ceftriaxone DRUG

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

Also known as: Rocephin, Cefin

B: Ceftriaxone

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kaohsiung Veterans General Hospital.: lead
• Bayer: collaborator

Study Sites (1)

Kaohsiung Veterans General Hospital

Kaohsiung City, 813, Taiwan

Location

Related Publications (27)

• 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.

  PMID: 18643760 BACKGROUND

• 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.

  PMID: 18826824 BACKGROUND

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

  PMID: 3532983 BACKGROUND

• 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.

  PMID: 7613255 BACKGROUND

• 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. doi: 10.1086/523006. No abstract available.

  PMID: 17990242 BACKGROUND

• 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. doi: 10.1016/j.jinf.2006.11.008. Epub 2006 Dec 18.

  PMID: 17175028 BACKGROUND

• 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. doi: 10.1007/s00268-003-6963-2. Epub 2003 Nov 14.

  PMID: 14612992 BACKGROUND

• Yeoh KG, Yap I, Wong ST, Wee A, Guan R, Kang JY. Tropical liver abscess. Postgrad Med J. 1997 Feb;73(856):89-92. doi: 10.1136/pgmj.73.856.89.

  PMID: 9122104 BACKGROUND

• 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.

  PMID: 12373305 BACKGROUND

• 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. doi: 10.1258/0049475054036904.

  PMID: 15970044 BACKGROUND

• 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. doi: 10.1111/j.1572-0241.2005.40310.x.

  PMID: 15667489 BACKGROUND

• Nadasy KA, Domiati-Saad R, Tribble MA. Invasive Klebsiella pneumoniae syndrome in North America. Clin Infect Dis. 2007 Aug 1;45(3):e25-8. doi: 10.1086/519424. Epub 2007 Jun 18.

  PMID: 17599300 BACKGROUND

• 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. doi: 10.1080/00365540701266763.

  PMID: 17701725 BACKGROUND

• 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. doi: 10.1007/s10792-007-9111-4. Epub 2007 Aug 1.

  PMID: 17668150 BACKGROUND

• 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. doi: 10.1086/425616. Epub 2004 Nov 9.

  PMID: 15578367 BACKGROUND

• 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.

  PMID: 16438021 BACKGROUND

• 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. doi: 10.1002/hep.20133.

  PMID: 15057896 BACKGROUND

• 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. doi: 10.1086/516369.

  PMID: 9636876 BACKGROUND

• 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.

  PMID: 12380791 BACKGROUND

• 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. doi: 10.2214/AJR.07.2173.

  PMID: 17715080 BACKGROUND

• 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. doi: 10.1128/AAC.48.3.1012-1016.2004.

  PMID: 14982797 BACKGROUND

• 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. doi: 10.1016/s0732-8893(00)00157-7.

  PMID: 10974581 BACKGROUND

• 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.

  PMID: 11605808 BACKGROUND

• 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. doi: 10.1128/AAC.47.7.2088-2092.2003.

  PMID: 12821451 BACKGROUND

• Paterson DL. "Collateral damage" from cephalosporin or quinolone antibiotic therapy. Clin Infect Dis. 2004 May 15;38 Suppl 4:S341-5. doi: 10.1086/382690.

  PMID: 15127367 BACKGROUND

• 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. doi: 10.1007/BF01975484.

  PMID: 2938072 BACKGROUND

• 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. doi: 10.1007/BF02075258.

  PMID: 3438150 BACKGROUND

MeSH Terms

Conditions

Liver Abscess

Interventions

Moxifloxacin; Ceftriaxone

Condition Hierarchy (Ancestors)

Abdominal Abscess; Abscess; Suppuration; Infections; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cefotaxime; Cephacetrile; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds

Study Officials

• Susan Shin-Jung Lee, M.D., M.Sc

  Kaohsiung Veterans General Hospital.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: May 6, 2009
• First Posted: May 7, 2009
• Study Start: May 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2011
• Last Updated: December 2, 2015

Record last verified: 2015-12

Locations

TW (1)