Empirical vs Tailored Therapy for H. Pylori Infection

NCT ID: NCT04006340

Last Updated: 2019-07-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-04
• Study Completion Date: 2019-08-31

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.

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.

Conditions

Helicobacter Pylori 23S rRNA Clarithromycin Resistance Mutation; Helicobacter Pylori Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Empirical group

Patients receive conventional triple therapy containing esomeprazole 40 mg, amoxicillin 1 g and clarithromycin 500 mg twice a day for 10 days

Group Type: PLACEBO_COMPARATOR

triple therapy

Intervention Type: COMBINATION_PRODUCT

esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg twice a day for 10 days

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.

Group Type: ACTIVE_COMPARATOR

triple therapy

Intervention Type: COMBINATION_PRODUCT

esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg twice a day for 10 days

quadruple therapy

Intervention Type: COMBINATION_PRODUCT

esomeprazole 40 mg and bismuth 300mg twice daily, tetracycline 500 mg four times daily, metronidazole 500mg three times daily for 10 days

dual-priming oligonucleotide-based multiplex (DPO)-PCR test

Intervention Type: DIAGNOSTIC_TEST

Resistance of clarithromycin 23S rRNA point mutation

Interventions

triple therapy

esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg twice a day for 10 days

Intervention Type: 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

Intervention Type: COMBINATION_PRODUCT

dual-priming oligonucleotide-based multiplex (DPO)-PCR test

Resistance of clarithromycin 23S rRNA point mutation

Intervention Type: DIAGNOSTIC_TEST

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Soo-Jeong Cho

Clinical Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Soo-Jeong Cho, M.D., ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Internal Medicine and Liver Research Institute,

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

References

Kim JL, Cho SJ, Chung SJ, Lee A, Choi J, Chung H, Kim SG. Empiric Versus Clarithromycin Resistance-Guided Therapy for Helicobacter pylori Based on Polymerase Chain Reaction Results in Patients With Gastric Neoplasms or Gastric Mucosa-Associated Lymphoid Tissue Lymphoma: A Randomized Controlled Trial. Clin Transl Gastroenterol. 2020 Sep;11(9):e00194. doi: 10.14309/ctg.0000000000000194.

Reference Type: DERIVED

PMID: 33094958 (View on PubMed)

Other Identifiers

1811-029-983

Identifier Type: -

Identifier Source: org_study_id