Tailored Therapy for Helicobacter Pylori Treatment in Patients With Penicillin Allergy

NCT03708848 | Completed Phase 4 DMC

• 1 other identifier: rjkls2017197
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

Increasing drug resistance presents a significant challenge to the efficacies of common empiric eradication regimens for Helicobacter pylori treatment in the mainland of China. Tailored therapy may be the best choice to achieve good efficacy, especially in patients with penicillin allergy. Few studies had evaluated the patients with penicillin allergy.This study is designed to evaluate the efficacy and safety of antibiotic sensitivity-based tailored therapy for Helicobacter pylori treatment in the patients with penicillin allergy.

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pylori; Tailored therapy; Penicillin allergy; Antimicrobial susceptibility testing

Outcome Measures

Primary Outcomes (1)

• Helicobacter pylori eradication rate

  Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was defined as negative result from urea breath test (\<4‰) (4‰ as the cutoff value).

  Six weeks after completion of therapy

Secondary Outcomes (2)

• Rate of adverse effects

  Within 7 days after completion of therapy

• Compliance rate

  Within 7 days after completion of therapy

Study Arms (1)

Tailored Therapy

EXPERIMENTAL

Medications will be adjusted according to clarithromycin，metronidazole and levofloxacin sensitivity. All drugs will be prescribed for 14 days.(1) When three of them or clarithromycin and metronidazole are sensitive, esomeprazole 20mg bid, clarithromycin 0.5g bid and metronidazole 0.4g bid will be prescribed. (2) When two of them (levofloxacin and clarithromycin or metronidazole) are sensitive, esomeprazole 20mg bid, levofloxacin 0.5g qd plus clarithromycin 0.5g bid or metronidazole 0.4g bid will be prescribed. (3) When one of them (clarithromycin or levofloxacin) is sensitive, esomeprazole 20mg bid, bismuth Potassium Citrate 600mg bid, metronidazole 0.4g qid plus clarithromycin 0.5g bid or levofloxacin 0.5g qd will be prescribed.(4) When only metronidazole or none of them is sensitive, esomeprazole 20mg bid, bismuth Potassium Citrate 600mg bid, metronidazole 0.4g qid plus tetracycline 0.4g qid will be prescribed.

Drug: Esomeprazole; Drug: Bismuth Potassium Citrate; Drug: Clarithromycin; Drug: Metronidazole; Drug: Levofloxacin; Drug: Tetracycline

Interventions

Esomeprazole DRUG

Proton pump inhibitor

Tailored Therapy

Bismuth Potassium Citrate DRUG

Gastric mucosal protective drug with anti-H. pylori effect

Tailored Therapy

Clarithromycin DRUG

antibiotic for H. pylori eradication

Tailored Therapy

Metronidazole DRUG

antibiotic for H. pylori eradication

Tailored Therapy

Levofloxacin DRUG

antibiotic for H. pylori eradication

Tailored Therapy

Tetracycline DRUG

antibiotic for H. pylori eradication

Tailored Therapy

Eligibility Criteria

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

You may qualify if:

• Participants with penicillin allergy who have non-ulcer functional dyspepsia or scarred peptic ulcer disease
• Ability and willingness to participate in the study and to sign and give informed consent
• confirmed H. pylori infection

You may not qualify if:

• Patients without penicillin allergy
• Less than 18 years old
• With previous gastric surgery
• Major systemic diseases
• Pregnancy or lactation
• Allergy to any of the study drugs

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200127, China

Location

Related Publications (1)

• Luo L, Huang Y, Liang X, Ji Y, Yu L, Lu H. Susceptibility-guided therapy for Helicobacter pylori-infected penicillin-allergic patients: A prospective clinical trial of first-line and rescue therapies. Helicobacter. 2020 Aug;25(4):e12699. doi: 10.1111/hel.12699. Epub 2020 May 19.

  PMID: 32428369 DERIVED

MeSH Terms

Interventions

Esomeprazole; Clarithromycin; Metronidazole; Levofloxacin; Tetracycline

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Erythromycin; Macrolides; Polyketides; Lactones; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Hong Lu, M.D.,Ph.D.

  Renji Hospital, School of Medicine, Shanghai Jiao Tong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor of Division of Gastroenterology and Hepatology of Renji Hospital,Professor of Medicine

Model Details: After antimicrobial susceptibility testing of Helicobacter pylori from biopsy samples, according to antibiotic resistance pattern of each one, give esomeprazole 20mg bid, bismuth potassium citrate 600mg bid and two sensitive ones of clarithromycin, metronidazole,levofloxacin and tetracycline.

Study Record Dates

• First Submitted: January 13, 2018
• First Posted: October 17, 2018
• Study Start: December 5, 2018
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: December 10, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)