Helicobacter InfectionsPhase 4NCT00816140
Levofloxacin Versus Clarithromycin Triple Therapy in First-Line Treatment for Helicobacter Pylori Eradication
A Phase 4 study testing Cravit based triple therapy and Klaricid based triple therapy in people with Helicobacter Infections, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Clarithromycin-based triple therapy containing a proton-pump inhibitor (PPI) twice daily, amoxicillin 1g twice daily, and clarithromycin 500 mg twice daily for 7 days is one of the standard firs-line therapy for Helicobacter pylori eradication. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Helicobacter Infections
- What is being tested?
- Cravit based triple therapy and Klaricid based triple therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 432 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2007to Jul 2009
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Asymptomatic subjects or symptomatic patients with H. pylori infection who are aged greater than 20 years and are willing to received eradication therapy for H. pylori
Who cannot join
- Children and teenagers aged less than 20 years
- Previous eradication therapy for H. pylori
- History of gastrectomy
- Gastric malignancy, including adenocarcinoma and lymphoma
- Previous allergic reaction to antibiotics (amoxicillin, clarithromycin, levofloxacin) and prompt pump inhibitors (lansoprazole)
- Use of prompt pump inhibitors (lansoprazole) and antibiotics (amoxicillin, clarithromycin, levofloxacin) in the recent 4 weeks
Show all 10Show fewer
- Active upper GI bleeding in the recent 1 week
- Contraindication to treatment drugs
- Pregnant or lactating women
- Severe concurrent disease or malignancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study of the Levofloxacin-Based and Clarithromycin-Based Triple Therapy in First-Line Treatment for Helicobacter Pylori Eradication and Change of Gut Flora and Drug Susceptibility Before and After Treatment
Clarithromycin-based triple therapy containing a proton-pump inhibitor (PPI) twice daily, amoxicillin 1g twice daily, and clarithromycin 500 mg twice daily for 7 days is one of the standard firs-line therapy for Helicobacter pylori eradication. However, because of unsatisfactory eradication rate (80-85%), the Maastricht III guideline recommended extending the treatment duration to increase the eradication rate. Recently, levofloxacin (500 mg qd)-based triple therapy has been shown to achieve an eradication rate of 90% for both the first- and second-line treatment for H. pylori eradication. Several studies have demonstrated that high dose (750mg) and short-course (5 days) levofloxacin is as effective and well tolerated as traditional dose (500mg) and course (10 days) for treatment of mild-to-severe community acquired pneumonia. The high dose and short-course therapy has the potential to increase patient compliance and reduce bacterial resistance to fluoroquinolones. However, whether increasing the dosage of levofloxacin from 500mg to 750 mg qd can augment the efficacy of triple therapy in eradication of H. pylori and shorten the duration of therapy remains unknown. Although levofloxacin-based regimen was presumed to be more effective, previous reports pointed the concern that resistance to fluoroquinolone and other antibiotics which susceptible to the pumping efflux of bacteriae would increase among the gut flora.
Read the detailed description
Determination of H. pylori status Prior to enrollment, the status of H. pylori infection will be determined by (1) rapid urease test (CLO test, Kimberly-Clark, USA) from antrum biopsy, (2) histological examination (Giemsa stain) of antral and body samples (two from the antral mucosa and two from the corpus mucosa), and (3) culture. Positive in any two of the three tests will be defined as positive for H. pylori infection. After-treatment H. pylori status will be determined by 13C-Urea Breath Test (13C-UBT) at 6 weeks after the completion of treatment. Successful eradication of H. pylori is defined as a negative 13C-UBT result.
Eradication Therapy Using a computer-generated number sequence, patients who meet the inclusion criteria and do not have any one of the exclusion criteria will be randomized to receive one of the following regimens: (1) CALa regimen: clarithromycin 500mg twice daily, amoxicillin 1000mg twice daily, and lansoprazole 30mg twice daily for 7 days, or (2) LALa regimen: levofloxacin 750mg (levofloxacin500 1.5 tablets) once daily, amoxicillin 1000mg twice daily, lansoprazole 30mg twice daily for 7 days (Figure 1). Adverse events will be recorded throughout the trial and during the follow-up period. Patients who do not return for 13C-UBT at 6 weeks after completion of treatment will be considered lost-to-follow-up and will be excluded from the per protocol (PP) analysis.
Rescue regimen for treatment failure after first-line regimen Patients who remained positive for H. pylori after the initial treatment as determined by the 13C-UBT will be followed by endoscopy. Biopsy will be done for H. pylori culture and antibiotic susceptibility test. All of them will then be treated with rescue regimen. The rescue regimens will be given in a cross-over manner (Figure 1). Patients who are treated with CALa regimen for 7 days as initial treatment will be treated with LALa regimen for 10 days as rescue treatment. Patients who are treated with LALa regimen for 7 days as initial treatment will be treated with CALa regimen for 10 days as rescue treatment.
Compliance and Adverse Effect Patients' compliance will be assessed by standardized interview at the end of treatment as well as by pill count in the medication boxes returned at the interview. Compliance is considered low when more than 20% of pills is found in the box. At enrollment, the patients will be informed of the common side effects from the studied antibiotics, including diarrhea, taste disturbance, nausea, bloating, loss of appetite, vomiting, abdominal pain, constipation, headache, and skin rash.
- Conditions
- Helicobacter Infections
- Being tested
- Cravit based triple therapy, Klaricid based triple therapy
- Keywords
- Helicobacter pylori, levofloxacin, clarithromycin, ERADICATION RATE
- Medical subject headings
- Helicobacter Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cravit based triple therapyDrug
Levofloxacin based triple therapy
LALa regimen: levofloxacin 750mg (levofloxacin500 1.5 tablets) once daily, amoxicillin 1000mg twice daily, lansoprazole 30mg twice daily for 7 days
Klaricid based triple therapyDrug
Clarithromycin based triple therapy
CALa regimen: clarithromycin 500mg twice daily, amoxicillin 1000mg twice daily, and lansoprazole 30mg twice daily for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Klaricid, triple therapy | Active comparator | Klaricid based triple therapy Receives: Drug: Klaricid based triple therapy |
| Cravit, triple therapy | Experimental | Cravit based triple therapy Receives: Drug: Cravit based triple therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary end-point of the study is to compare the eradication rate of levofloxacin-based therapy (LALa regimen for 7 days) to that achieved with the standard first line regimen (CALa regimen for 7 days).
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2008 (estimated)
- Study startJun 2007
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Helicobacter InfectionsStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- 432 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jawtown Lin, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00816140
- Sponsor's protocol ID
- 200702009M
- Status last verified
- Mar 2011
- First submitted
- 6 Aug 2007
- Last updated
- 22 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Liou JM, Lin JT, Chang CY, Chen MJ, Cheng TY, Lee YC, Chen CC, Sheng WH, Wang HP, Wu MS. Levofloxacin-based and clarithromycin-based triple therapies as first-line and second-line treatments for Helicobacter pylori infection: a randomised comparative trial with crossover design. Gut. 2010 May;59(5):572-8. doi: 10.1136/gut.2009.198309.
PubMed 20427390
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of the Levofloxacin-Based and Clarithromycin-Based Triple Therapy in First-Line Treatment for Helicobacter Pylori Eradication and Change of Gut Flora and Drug Susceptibility Before and After Treatment
- ClinicalTrials.gov ID
- NCT00816140
- Acronym / sponsor ID
- 200702009M
- Conditions
- Helicobacter Infections
- Keywords
- Helicobacter pylori, levofloxacin, clarithromycin, ERADICATION RATE
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 432 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 31 Dec 2008 (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.
Clarithromycin-based triple therapy containing a proton-pump inhibitor (PPI) twice daily, amoxicillin 1g twice daily, and clarithromycin 500 mg twice daily for 7 days is one of the standard firs-line therapy for Helicobacter pylori eradication. However, because of unsatisfactory eradication rate (80-85%), the Maastricht III guideline recommended extending the treatment duration to increase the eradication rate. Recently, levofloxacin (500 mg qd)-based triple therapy has been shown to achieve an eradication rate of 90% for both the first- and second-line treatment for H. pylori eradication. Several studies have demonstrated that high dose (750mg) and short-course (5 days) levofloxacin is as effective and well tolerated as traditional dose (500mg) and course (10 days) for treatment of mild-to-severe community acquired pneumonia. The high dose and short-course therapy has the potential to increase patient compliance and reduce bacterial resistance to fluoroquinolones. However, whether increasing the dosage of levofloxacin from 500mg to 750 mg qd can augment the efficacy of triple therapy in eradication of H. pylori and shorten the duration of therapy remains unknown. Although levofloxacin-based regimen was presumed to be more effective, previous reports pointed the concern that resistance to fluoroquinolone and other antibiotics which susceptible to the pumping efflux of bacteriae would increase among the gut flora.
Detailed description
Determination of H. pylori status Prior to enrollment, the status of H. pylori infection will be determined by (1) rapid urease test (CLO test, Kimberly-Clark, USA) from antrum biopsy, (2) histological examination (Giemsa stain) of antral and body samples (two from the antral mucosa and two from the corpus mucosa), and (3) culture. Positive in any two of the three tests will be defined as positive for H. pylori infection. After-treatment H. pylori status will be determined by 13C-Urea Breath Test (13C-UBT) at 6 weeks after the completion of treatment. Successful eradication of H. pylori is defined as a negative 13C-UBT result.
Eradication Therapy Using a computer-generated number sequence, patients who meet the inclusion criteria and do not have any one of the exclusion criteria will be randomized to receive one of the following regimens: (1) CALa regimen: clarithromycin 500mg twice daily, amoxicillin 1000mg twice daily, and lansoprazole 30mg twice daily for 7 days, or (2) LALa regimen: levofloxacin 750mg (levofloxacin500 1.5 tablets) once daily, amoxicillin 1000mg twice daily, lansoprazole 30mg twice daily for 7 days (Figure 1). Adverse events will be recorded throughout the trial and during the follow-up period. Patients who do not return for 13C-UBT at 6 weeks after completion of treatment will be considered lost-to-follow-up and will be excluded from the per protocol (PP) analysis.
Rescue regimen for treatment failure after first-line regimen Patients who remained positive for H. pylori after the initial treatment as determined by the 13C-UBT will be followed by endoscopy. Biopsy will be done for H. pylori culture and antibiotic susceptibility test. All of them will then be treated with rescue regimen. The rescue regimens will be given in a cross-over manner (Figure 1). Patients who are treated with CALa regimen for 7 days as initial treatment will be treated with LALa regimen for 10 days as rescue treatment. Patients who are treated with LALa regimen for 7 days as initial treatment will be treated with CALa regimen for 10 days as rescue treatment.
Compliance and Adverse Effect Patients' compliance will be assessed by standardized interview at the end of treatment as well as by pill count in the medication boxes returned at the interview. Compliance is considered low when more than 20% of pills is found in the box. At enrollment, the patients will be informed of the common side effects from the studied antibiotics, including diarrhea, taste disturbance, nausea, bloating, loss of appetite, vomiting, abdominal pain, constipation, headache, and skin rash.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Klaricid, triple therapy | Active comparator | Drug: Klaricid based triple therapyKlaricid based triple therapy |
| Cravit, triple therapy | Experimental | Drug: Cravit based triple therapyCravit based triple therapy |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Asymptomatic subjects or symptomatic patients with H. pylori infection who are aged greater than 20 years and are willing to received eradication therapy for H. pylori
Key exclusion criteria (10 listed)
- Children and teenagers aged less than 20 years
- Previous eradication therapy for H. pylori
- History of gastrectomy
- Gastric malignancy, including adenocarcinoma and lymphoma
- Previous allergic reaction to antibiotics (amoxicillin, clarithromycin, levofloxacin) and prompt pump inhibitors (lansoprazole)
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 |
|---|---|---|
| Cravit based triple therapyLevofloxacin based triple therapy LALa regimen: levofloxacin 750mg (levofloxacin500 1.5 tablets) once daily, amoxicillin 1000mg twice daily, lansoprazole 30mg twice daily for 7 days | Drug | Cravit, triple therapy |
| Klaricid based triple therapyClarithromycin based triple therapy CALa regimen: clarithromycin 500mg twice daily, amoxicillin 1000mg twice daily, and lansoprazole 30mg twice daily for 7 days | Drug | Klaricid, triple therapy |
Primary outcome
Primary end-point of the study is to compare the eradication rate of levofloxacin-based therapy (LALa regimen for 7 days) to that achieved with the standard first line regimen (CALa regimen for 7 days).
Time frame: One year
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 22 Apr 2011.
- Derived from this study: PubMed 20427390Liou JM, Lin JT, Chang CY, Chen MJ, Cheng TY, Lee YC, Chen CC, Sheng WH, Wang HP, Wu MS. Levofloxacin-based and clarithromycin-based triple therapies as first-line and second-line treatments for Helicobacter pylori infection: a randomised comparative trial with crossover design. Gut. 2010 May;59(5):572-8. doi: 10.1136/gut.2009.198309.
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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.
Jawtown Lin principal investigator
National Taiwan University 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 Cravit based triple therapy and Klaricid based triple therapy in people with Helicobacter Infections, run by National Taiwan University 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 1 inclusion and 10 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 22 Apr 2011. 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?
Primary end-point of the study is to compare the eradication rate of levofloxacin-based therapy (LALa regimen for 7 days) to that achieved with the standard first line regimen (CALa regimen for 7 days). (time frame: One year). 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 NCT00816140, which also lists 1 linked publication.
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 22 Apr 2011.