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Completed

NCT Number: NCT00895089

Moxifloxacin Versus Ceftriaxone in the Treatment of Primary Pyogenic Liver Abscess

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kaohsiung Veterans General Hospital

Kaohsiung City, 813, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Moxifloxacin (Avelox)

Drug

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

Other names: Avelox

Ceftriaxone

Drug

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

Other names: Rocephin, Cefin

Primary outcomes

  1. Treatment efficacy

    Time frame: 21 days

Secondary outcomes

  1. Clinical response

    Time frame: Day 3, 7 and 14

  2. Clinical and radiological response

    Time frame: 21 days

  3. All cause mortality

    Time frame: 21 days

  4. Mortality attributable to liver abscess during treatment

    Time frame: 21 days

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

    Time frame: 21 days

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

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Kaohsiung Veterans General Hospital.

Other

Collaborators

  • Bayer

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
May 7, 2009
Registry last updated
Dec 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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