Intraluminal Mono-antibiotic Therapy for Helicobacter Pylori Infection - A Comparison of Levofloxacin Powder and Levofloxacin Solution
Condition: Helicobacter Pylori Infection
MeSH terms: Infections; Helicobacter Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      Helicobacter pylori (H. pylori) is an important causal factor of chronic gastritis, peptic
      ulcer disease, gastric cancer and gastric lymphoma. The World Health Organization classified
      H. pylori as a Group 1 carcinogen in 1994. Endoscopic examination is indicated to confirm the
      above diagnosis for patient with H. pylori infection. The eradication of H. pylori can reduce
      the recurrence rate of peptic ulcer disease and even has the potential to prevent gastric
      cancer. H. pylori is the most common chronic bacterial infection in humans. The prevalence of
      H. pylori is about 30-50% in the Western adult population. It is estimated that about 50% of
      people are infected with this bacterium in Taiwan.

      Triple therapy which contains a proton pump inhibitor and two antibiotics among
      clarithromycin, amoxicillin, and metronidazole is the most commonly used regimen for H.
      pylori eradication. The treatment duration is 7 to 14 days. However, the eradication rate of
      standard triple therapy has fallen below 80% in many countries due to the worldwide
      increasing prevalence of antibiotic resistant strains.

      Several strategies have been proposed to increase the eradication rate in the first line
      therapy or as a rescue therapy, including extending the treatment duration to 14 days,
      increasing the doses of antibiotics, the use of four or even five drugs regimen (sequential,
      concomitant, quadruple or quintuple therapy), and other antibiotics such as levofloxacin.
      However, these therapies may increase the side effects and costs of treatment, decrease the
      compliance of patients and increase the rate of worldwide antibiotic resistance steadily. The
      WHO has listed H. Pylori as one of 16 antibiotic-resistant bacteria that have the greatest
      threat to human health in February, 2017.

      The most commonly used oral antibiotics for the treatment of H. pylori are
      Amoxicillin、Clarithromycin、Metronidazole、Levofloxacin and Tetracycline.

      However, with the increasing rates of antibiotic-resistance for Clarithromycin and
      Metronidazole, the Clarithromycin and Metronidazole were replaced by Levofloxacin as a first
      line or second line treatment in some area. However, the eradication rate of
      Levofloxacin-containing triple therapy is suboptimal in many countries. The investigators aim
      to compare the efficacy of different formulation between Levofloxacin Powder and Levofloxacin
      Solution in the Intraluminal levofloxacin therapy, and to improve the eradication efficacy of
      one-week Levofloxacin-containing triple therapy via the Intraluminal therapy.
    

Detailed description: 
      During the endoscopic examination, patient is sedated with intravenous Dormicum 5mg
      (5mg/1ml/amp), the vital signs will be closely monitored by physiological monitor (PHILIPS
      SureSigns VM6). The treatment will be terminated immediately if unstable vital sign detected
      or if patient asks for termination. Patients will receive tests to evaluate H. pylori
      colonization in the gastric cardia (UFT300) and duodenal bulb (CLO). With endoscope
      apparatus, the gastric mucus is irrigated with acetylcysteine solution and the pH value of
      gastric juice will be measured with the pH test strips before irrigation and after
      irrigation.

      The investigators randomly assigned medicaments containing different formulation (powder or
      solution ) of levofloxacin to dispense on the surface of gastric mucosa and duodenal mucosa
      of duodenal bulb. After the intraluminal therapy, patients will rest for 30 to 60 minutes and
      go home if the effect of sedation subsided. Patients can take meal if no abdominal
      discomfort. C13-Urea breath test (UBT) will be used to assess the existence of H. pylori 6
      weeks after the intraluminal therapy. Patients failed to achieve intraluminal eradication of
      H. pylori will be randomly assigned to 7-day or 14-day levofloxacin-containing triple therapy
      (levofloxacin 500 mg once daily, amoxicillin 1 g twice daily, and esomeprazole 40 mg twice
      daily). The C13-UBT will be used to assess the existence of H. pylori 6 weeks after the oral
      antibiotic therapy. The overall eradication rates of the intraluminal therapy plus the oral
      antibiotics therapies will be evaluated.
    

Intervention name(s): Levofloxacin film-coated tablet; Levofloxacin intravenous solution
Intervention type(s): Drug; Drug
Intervention description(s): 50 participants are randomly assigned to receive intraluminal eradication of H. pylori.
with medicaments containing levofloxacin powder or levofloxacin solution.; 50 participants are randomly assigned to receive intraluminal eradication of H. pylori.
with medicaments containing levofloxacin powder or levofloxacin solution.
Other intervention name(s): Leflodal film-coated tablet; Cravit intravenous solution
Intervention MeSH terms: Levofloxacin; Ofloxacin; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 50 participants are randomly assigned to receive intraluminal eradication of H. pylori.
with medicaments containing levofloxacin powder or levofloxacin solution. Patients failed to achieve intraluminal eradication of H. pylori will be randomly assigned to 7-day or 14-day levofloxacin-containing triple therapy (levofloxacin 500 mg once daily, amoxicillin 1 g twice daily, and esomeprazole 40 mg twice daily).
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Levofloxacin; Amoxicillin; Proton pump inhibitor; Helicobacter Pylori