Intraluminal Mono-antibiotic Therapy for Helicobacter Pylori Infection - A Comparison of Levofloxacin Powder and Levofloxacin Solution

NCT03832465 | Completed Phase 4

• 1 other identifier: 18MMHIS168
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Helicobacter Pylori Infection

Keywords

Levofloxacin; Amoxicillin; Proton pump inhibitor; Helicobacter Pylori

Outcome Measures

Primary Outcomes (1)

• Eradication rate of the intraluminal Levofloxacin therapy

  A Comparison of different formulation between Levofloxacin Powder and Levofloxacin solution

  C13-UBT will be used to assess the existence of H. pylori 6 weeks after the intraluminal therapy.

Secondary Outcomes (3)

• Incidence of adverse effects of the intraluminal Levofloxacin therapy

  within 7 days after finishing the intraluminal therapies

• Eradication rates of 7-day or 14-day levofloxacin-containing triple therapy

  C13-UBT will be used to assess the existence of H. pylori 6 weeks after the levofloxacin-containing triple herapies.

• The overall eradication rate

  3-6 months after finishing the intraluminal therapy

Study Arms (2)

Intraluminal Levofloxacin powder therapy

EXPERIMENTAL

Group A Crashed powder of film-coated Levofloxacin Tablet (1 gm) for the Intraluminal therapy

Drug: Levofloxacin film-coated tablet

Intraluminal Levofloxacin solution therapy

ACTIVE COMPARATOR

Group B Intravenous solution of Levofloxacin (1 gm) for the Intraluminal therapy

Drug: Levofloxacin intravenous solution

Interventions

Levofloxacin film-coated tablet DRUG

50 participants are randomly assigned to receive intraluminal eradication of H. pylori. with medicaments containing levofloxacin powder or levofloxacin solution.

Also known as: Leflodal film-coated tablet

Intraluminal Levofloxacin powder therapy

Levofloxacin intravenous solution DRUG

50 participants are randomly assigned to receive intraluminal eradication of H. pylori. with medicaments containing levofloxacin powder or levofloxacin solution.

Also known as: Cravit intravenous solution

Intraluminal Levofloxacin solution therapy

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged between 20 years and 75 years
• Patients have H. pylori infection and have not treated with oral antibiotics
• Patients are willing to receive the intraluminal therapy. The written informed consents will be obtained from all patients prior to enrollment.

You may not qualify if:

• Children and teenagers aged less than 20 years or adult greater than 75 years
• Contraindication for endoscopic examination or food retention in the gastric lumen.
• History of gastrectomy; Gastroduodenal stenosis、deformity or obstruction; Gastroduodenal malignancy, including adenocarcinoma and lymphoma
• Contraindication to treatment drugs: previous allergic reaction to Proton pump inhibitors, Amoxicillin, Levofloxacin, Acetylcystein, and pregnant or lactating women
• Severe concurrent acute or chronic illness: renal failure, decompensated cirrhosis of liver, incurable malignant disease
• Patients who cannot give informed consent by himself or herself.

Sponsors & Collaborators

• Mackay Memorial Hospital: lead

Study Sites (1)

Division of Gastroenterology and Department of Internal Medicine, Mackay Memorial Hospital, Taipei, Taiwan

Taipei, 10449, Taiwan

Location

Study Officials

• Tai-cherng Liou, MD

  Division of Gastroenterology and Department of Internal Medicine, Mackay Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Model Details: 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).

Study Record Dates

• First Submitted: February 5, 2019
• First Posted: February 6, 2019
• Study Start: June 14, 2019
• Primary Completion: July 1, 2020
• Study Completion: December 27, 2020
• Last Updated: February 5, 2021

Record last verified: 2021-02

Locations

TW (1)