Liver AbscessPhase 4NCT00895089
Moxifloxacin Versus Ceftriaxone in the Treatment of Primary Pyogenic Liver Abscess
A Phase 4 study testing Moxifloxacin (Avelox) and ceftriaxone in people with Liver Abscess, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Liver Abscess
- What is being tested?
- Moxifloxacin (Avelox) and ceftriaxone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2009to Dec 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this 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
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
- Being tested
- Moxifloxacin (Avelox), ceftriaxone
- Keywords
- liver abscess, moxifloxacin, ceftriaxone, treatment
- Medical subject headings
- Liver Abscess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moxifloxacin (Avelox)Drug
Also called Avelox
moxifloxacin 400 mg IV qd for 14 days, followed by moxifloxacin 400 mg po qd for another 1 week
ceftriaxoneDrug
Also called Rocephin, Cefin
ceftriaxone 2 gm IV q 12 h for 14 days, followed by cephalexin 1 gm PO q 6 h for 1 week
| Study group | Role | What they receive |
|---|---|---|
| A: Moxifloxacin | Experimental | Moxifloxacin 400mg IV once daily for 14 days, then 400mg PO once daily for 7 days. Receives: 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. Receives: Drug: ceftriaxone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment efficacy
Measured: 21 days
Secondary outcomes (6)
Clinical response
Measured: Day 3, 7 and 14
Clinical and radiological response
Measured: 21 days
All cause mortality
Measured: 21 days
Mortality attributable to liver abscess during treatment
Measured: 21 days
Rates of complication (metastatic infections to the central nervous system and/or eyes)
Measured: 21 days
Rates of gastrointestinal colonization of Klebsiella pneumoniae in patients and rates of resistance post-antibiotic use.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2009 (estimated)
- Study startMay 2009
- Primary completionDec 2010
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Liver AbscessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Veterans General Hospital.
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Principal investigator, Susan Shin-Jung Lee, Kaohsiung Veterans General Hospital.
- Investigators
- Susan Shin-Jung Lee, M.D., M.Sc, Principal investigator, Kaohsiung Veterans General Hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00895089
- Sponsor's protocol ID
- VGHKS98-CT2-20
- Status last verified
- Dec 2015
- First submitted
- 6 May 2009
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1086/590932.
PubMed 18643760Tsai 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.
PubMed 18826824Liu YC, Cheng DL, Lin CL. Klebsiella pneumoniae liver abscess associated with septic endophthalmitis. Arch Intern Med. 1986 Oct;146(10):1913-6.
PubMed 3532983Chang 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.
PubMed 7613255Yu 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.
PubMed 17990242Chung 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.
PubMed 17175028Tan 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.
PubMed 14612992Yeoh 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.
PubMed 9122104Okano 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.
PubMed 12373305Wiwanitkit 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.
PubMed 15970044Lederman 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.
PubMed 15667489Nadasy 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.
PubMed 17599300Keynan 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.
PubMed 17701725Karama 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.
PubMed 17668150Rahimian 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.
PubMed 15578367
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Open-Labeled, Active-Controlled Comparison of Moxifloxacin Versus Ceftriaxone in the Treatment of Primary Pyogenic Liver Abscess: A Pilot Study
- ClinicalTrials.gov ID
- NCT00895089
- Acronym / sponsor ID
- VGHKS98-CT2-20
- Conditions
- Liver Abscess
- Keywords
- liver abscess, moxifloxacin, ceftriaxone, treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Kaohsiung Veterans General Hospital.University, hospital or other
- Collaborators
- Bayer
- Study start
- May 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 7 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: Moxifloxacin | Experimental | Drug: Moxifloxacin (Avelox)Moxifloxacin 400mg IV once daily for 14 days, then 400mg PO once daily for 7 days. |
| B: Ceftriaxone | Active comparator | Drug: ceftriaxoneCeftriaxone 2gm IV every 12 hours for 14 days, then cephalexin 1gm PO every 6 hours for 7 days. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moxifloxacin (Avelox)Also: Aveloxmoxifloxacin 400 mg IV qd for 14 days, followed by moxifloxacin 400 mg po qd for another 1 week | Drug | A: Moxifloxacin |
| ceftriaxoneAlso: Rocephin, Cefinceftriaxone 2 gm IV q 12 h for 14 days, followed by cephalexin 1 gm PO q 6 h for 1 week | Drug | B: Ceftriaxone |
Primary outcome
Treatment efficacy
Time frame: 21 days
6 secondary outcomes
Clinical response
Time frame: Day 3, 7 and 14
Clinical and radiological response
Time frame: 21 days
All cause mortality
Time frame: 21 days
Mortality attributable to liver abscess during treatment
Time frame: 21 days
Rates of complication (metastatic infections to the central nervous system and/or eyes)
Time frame: 21 days
Rates of gastrointestinal colonization of Klebsiella pneumoniae in patients and rates of resistance post-antibiotic use.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
- Background: PubMed 18643760Lee 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.
- Background: PubMed 18826824Tsai 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.
- Background: PubMed 3532983Liu YC, Cheng DL, Lin CL. Klebsiella pneumoniae liver abscess associated with septic endophthalmitis. Arch Intern Med. 1986 Oct;146(10):1913-6.
- Background: PubMed 7613255Chang 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.
- Background: PubMed 17990242Yu 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.
- Background: PubMed 17175028Chung 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.
- Background: PubMed 14612992Tan 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.
- Background: PubMed 9122104Yeoh 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.
- Background: PubMed 12373305Okano 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.
- Background: PubMed 15970044Wiwanitkit 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.
- Background: PubMed 15667489Lederman 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.
- Background: PubMed 17599300Nadasy 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.
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Liver Abscess
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Shin-Jung Lee, M.D., M.Sc principal investigator
Kaohsiung Veterans General Hospital.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Moxifloxacin (Avelox) and ceftriaxone in people with Liver Abscess, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment efficacy (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00895089, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2015.