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

NCT00816140 | Completed Phase 4

• 1 other identifier: 200702009M
• Study Type: interventional
• Target: 432
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Helicobacter Infections

Keywords

Helicobacter pylori; levofloxacin; clarithromycin; ERADICATION RATE

Outcome Measures

Primary Outcomes (1)

• 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).

  One year

Study Arms (2)

Klaricid, triple therapy

ACTIVE COMPARATOR

Klaricid based triple therapy

Drug: Klaricid based triple therapy

Cravit, triple therapy

EXPERIMENTAL

Cravit based triple therapy

Drug: Cravit based triple therapy

Interventions

Cravit based triple therapy DRUG

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

Cravit, triple therapy

Klaricid based triple therapy DRUG

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

Klaricid, triple therapy

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 20427390 DERIVED

MeSH Terms

Conditions

Helicobacter Infections

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Jawtown Lin

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 6, 2007
• First Posted: December 31, 2008
• Study Start: June 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: April 22, 2011

Record last verified: 2011-03

Locations

TW (1)