Empirical vs Tailored Therapy for H. Pylori Infection

• ClinicalTrials.gov Identifier: NCT04006340
• Recruitment Status: Enrolling by invitation
• First Posted: July 5, 2019
• Last Update Posted: July 5, 2019
• Sponsor: Seoul National University Hospital
• Information provided by (Responsible Party): Soo-Jeong Cho, Seoul National University Hospital

Study Description

Brief Summary:

We aimed to compare the efficacy of genotypic resistance-guided tailored therapy vs empirical therapy for eradication of Helicobacter pylori (H. pylori) infection in randomized controlled trials.

Condition or disease	Intervention/treatment	Phase
Helicobacter Pylori 23S rRNA Clarithromycin Resistance Mutation; Helicobacter Pylori Infection	Combination Product: triple therapy; Combination Product: quadruple therapy; Diagnostic Test: dual-priming oligonucleotide-based multiplex (DPO)-PCR test	Not Applicable

Detailed Description:

Empirical therapy is conventional triple therapy (proton pump inhibitor (PPI) standard dose, amoxicillin 1 g and clarithromycin 500 mg twice a day for 10 days). Genotypic resistance-guided tailored therapy is the method which is chosen by DPO-PCR test. While the patients who have positive result of clarithromycin resistance receive the quadruple therapy(PPI standard dose, bismuth 300mg twice daily, tetracycline 500 mg four times daily, metronidazole 500mg three times daily for 10 days), clarithromycin susceptible patients receive the triple therapy.

H. pylori is difficult to cultivate, cultivation of H. pylori and minimum inhibitory concentration test as a resistance test method are very difficult and take a long time. Recently, tailored treatment based on clarithromycin susceptibility has been proposed by dual-priming oligonucleotide-based multiplex (DPO)-PCR test. This is a method to confirm the mutation of A2142G and A2143G by PCR, which are known to be highly related to the resistance of clarithromycin 23S rRNA point mutation. This test is performed only by gastric biopsy. The examination time is also short as several hours, and sensitivity and specificity are about 80-85%.

Antibiotic resistance of H. pylori, especially clarithromycin resistance, is a cause of major failure of its eradication, and Korea 's clarithromycin resistance rate is reported to be about 37%. The eradication rate of standard triple therapy reported in Korea is also unsatisfactory as antibiotic resistance rate of H. pylori increases. The ideal eradication rate for H. pylori is approximately 90%, but in the meta-analysis of the recently reported primary eradication, the overall eradication rate was 74.6% in the intention to treat analysis.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 62 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparison of Empirical and Genotypic Resistance Guided Tailored Therapy for Helicobacter Pylori Infection
• Actual Study Start Date: January 4, 2019
• Estimated Primary Completion Date: August 31, 2019
• Estimated Study Completion Date: August 31, 2019

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Empirical group; Patients receive conventional triple therapy containing esomeprazole 40 mg, amoxicillin 1 g and clarithromycin 500 mg twice a day for 10 days	Combination Product: triple therapy; esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg twice a day for 10 days
Active Comparator: Genotypic resistance-guided tailored group; Patients receive triple or quadruple therapy by resistance-associated mutations in 23S ribosomal RNA which are identified by polymerase chain reaction (PCR). Triple therapy contains esomeprazole 40 mg, amoxicillin 1 g and clarithromycin 500 mg twice a day for 10 days and quadruple therapy contains esomeprazole 40 mg and bismuth 300mg twice daily, tetracycline 500 mg four times daily, metronidazole 500mg three times daily for 10 days.	Combination Product: triple therapy; esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg twice a day for 10 days; Combination Product: quadruple therapy; esomeprazole 40 mg and bismuth 300mg twice daily, tetracycline 500 mg four times daily, metronidazole 500mg three times daily for 10 days; Diagnostic Test: dual-priming oligonucleotide-based multiplex (DPO)-PCR test; Resistance of clarithromycin 23S rRNA point mutation

Outcome Measures

Primary Outcome Measures :

1. Eradication rate [ Time Frame: 13C-UBT at least 4 weeks after completion of treatment ]
   Eradication rate of H. pylori infection

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Patients with H. pylori who had undergone endoscopic resection for gastric neoplasm
• Patients with H. pylori who had diagnosed at peptic ulcer disease, MALT lymphoma

Exclusion Criteria:

• history of gastrectomy
• patients aged younger than 20 years or older than 80 years
• history of H. pylori eradication therapies or other antibiotics therapy within a month
• previous allergic reaction to the study drugs (amoxicillin, clarithromycin, metronidazole, tetracycline, and esomeprazole)
• contraindication to treatment drugs
• pregnant or lactating women
• severe concurrent illness

Contacts and Locations

Locations

Korea, Republic of

Seoul National University Hospital

Seoul, Korea, Republic of, 03080

Sponsors and Collaborators

Seoul National University Hospital

Investigators

• Principal Investigator: Soo-Jeong Cho, M.D., ph.D.; Department of Internal Medicine and Liver Research Institute,

More Information

• Responsible Party: Soo-Jeong Cho, Clinical Associate Professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT04006340
• Other Study ID Numbers: 1811-029-983
• First Posted: July 5, 2019
• Last Update Posted: July 5, 2019
• Last Verified: July 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Infection; Communicable Diseases; Helicobacter Infections; Gram-Negative Bacterial Infections; Bacterial Infections