Levofloxacin Versus Clarithromycin Triple Therapy in First-Line Treatment for Helicobacter Pylori Eradication

This study has been completed.
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00816140
First received: August 6, 2007
Last updated: April 21, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Helicobacter Infections
Drug: Cravit based triple therapy
Drug: Klaricid based triple therapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 432
Study Start Date: June 2007
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Klaricid, triple therapy
Klaricid based triple therapy
Drug: Klaricid based triple therapy

Clarithromycin based triple therapy

CALa regimen: clarithromycin 500mg twice daily, amoxicillin 1000mg twice daily, and lansoprazole 30mg twice daily for 7 days

Experimental: Cravit, triple therapy
Cravit based triple therapy
Drug: Cravit based triple therapy

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


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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Active upper GI bleeding in the recent 1 week
  • Contraindication to treatment drugs
  • Pregnant or lactating women
  • Severe concurrent disease or malignancy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00816140

Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 10002
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Jawtown Lin National Taiwan University Hospital
  More Information

No publications provided by National Taiwan University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00816140     History of Changes
Other Study ID Numbers: 200702009M
Study First Received: August 6, 2007
Last Updated: April 21, 2011
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Helicobacter pylori
levofloxacin
clarithromycin
ERADICATION RATE

Additional relevant MeSH terms:
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Clarithromycin
Levofloxacin
Ofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 16, 2014