The Efficacy of the 7 Days Tailored Therapy as 2nd Rescue Therapy for Eradication of H. Pylori Infection

Seoul National University

Status: Terminated

Conditions: Helicobacter Infection

Treatments: Procedure: H. pylori culture and antimicrobial susceptibility testing; Drug: 7 days tailored therapy Proton Pump Inhibitor; Drug: Tetracycline; Drug: tripotassium dicitrate bismuthate; Drug: Amoxicillin; Drug: Metronidazole; Drug: Moxifloxacin; Drug: 14 days empirical bismuth quadruple therapy (Proton pump inhibitor)

Study type: Interventional

Funder types: Other

Identifiers

NCT02359331

B1408/285-005

Details and patient eligibility

About

As increasing the antibiotics resistance, the effectiveness of traditional Helicobacter pylori (H. pylori) therapies has been declined coincidentally.

In this study, the investigators evaluated the efficacy of H. pylori eradication between a 7 days personalized therapy for H. pylori infection based on the results of antibiotics resistance by using H. pylori culture and minimal inhibitory concentration (MIC) and the 14 days bismuth contained quadruple 2nd rescue regimens, and the investigators analyzed the prevalence of the antibiotic resistance after 1st eradication of H. pylori in the tailored therapy group.

Full description

The patients who had shown the evidence of persistent H. pylori infection after the 1st eradication were enrolled for this study.

After giving the informed consent about the method and efficacy (ITT and PP analysis) of the 14 days bismuth quadruple 2nd rescue therapy and the 7 days tailored therapy for H. pylori infection based on culture and MIC, the patients were randomly classified into the two regimen group under the patient's agreement and underwent 2nd eradication [14 days bismuth-based quadruple therapy (Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d.), or 7 days tailored therapy based on H. pylori culture and MIC (select the 2nd rescue regimen between 7 days of bismuth-based quadruple therapy or 7 days moxifloxacin-containing triple therapy (PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.) according to antibiotics susceptibility.

This study was designed to evaluate the success of eradication for enrolled participants by methods of an open labelled randomized prospectively.

Enrollment: 370 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• The patients who proved a failure of 1st eradication of H. pylori with Proton pump inhibitor based triple therapy (PPI bid + amoxacillin 1g b.i.d + Clarithromycin 500 mg b.i.d) or sequential therapy (initial 5-day therapy with a combination of PPI b.i.d and amoxicillin 1g b.i.d, followed by 5 days of PPI b.i.d., clarithromycin 500mg b.i.d., and metronidazole 500mg t.i.d) following three methods

  1. positive rapid urease test (CLOtest)
  2. histologic evidence of H. pylori by modified Giemsa staining
  3. positive 13C-Urea breath test

• Male and female Korean Adult (Aged ≥ 18 years)

Exclusion criteria

• Patients who received two or more eradication therapy for H. pylori infection
• H. pylori eradication failure because of poor compliance
• the administration of antibiotics or the consumption of bismuth salts within 4 weeks or the administration of a proton pump inhibitor (PPI) within 2 weeks
• Advanced gastric cancer or other malignancy
• Abnormal liver function or liver cirrhosis
• Abnormal renal function or chronic kidney disease
• Other severe concurrent diseases
• Previous allergic reactions to the study drugs
• Pregnant or lactating women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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370 participants in 2 patient groups

14 days PBMT group

Active Comparator group

Description:

Giving the 14 days bismuth quadruple regimen as 2nd rescue therapy for eradication of persistent H. pylori infection Drug regimen Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d

Treatment:

Drug: Metronidazole

Drug: 14 days empirical bismuth quadruple therapy (Proton pump inhibitor)

Drug: tripotassium dicitrate bismuthate

Drug: Tetracycline

7 days tailored therapy group

Experimental group

Description:

According the antimicrobial susceptibility testing, the H. pylori isolates were resistant to moxifloxacin, 7 days PBMT regimen were prescribed; if the isolates were resistant to metronidazole, 7 days moxiflxacin based triple regimen (PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d) were prescribed.

Treatment:

Drug: Moxifloxacin

Drug: Amoxicillin

Procedure: H. pylori culture and antimicrobial susceptibility testing

Drug: 7 days tailored therapy Proton Pump Inhibitor