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Trial record 14 of 21 for:    "Bacterial Infectious Disease" | "Guaifenesin"

Tailored Therapy for Helicobacter Pylori Treatment in Patients With Penicillin Allergy

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ClinicalTrials.gov Identifier: NCT03708848
Recruitment Status : Recruiting
First Posted : October 17, 2018
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
Hong Lu, MD, Shanghai Jiao Tong University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Drug: Esomeprazole Drug: Bismuth Potassium Citrate Drug: Clarithromycin Drug: Metronidazole Drug: Levofloxacin Drug: Tetracycline Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Intervention Model: Single Group Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Antibiotic Susceptibility-based Tailored Therapy for Helicobacter Pylori Treatment in Patients With Penicillin Allergy: a Prospective Clinical Trial
Actual Study Start Date : January 3, 2018
Estimated Primary Completion Date : January 31, 2019
Estimated Study Completion Date : March 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
Drug Information available for: Penicillins

Arm Intervention/treatment
Experimental: Tailored Therapy
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
Proton pump inhibitor

Drug: Bismuth Potassium Citrate
Gastric mucosal protective drug with anti-H. pylori effect

Drug: Clarithromycin
antibiotic for H. pylori eradication

Drug: Metronidazole
antibiotic for H. pylori eradication

Drug: Levofloxacin
antibiotic for H. pylori eradication

Drug: Tetracycline
antibiotic for H. pylori eradication




Primary Outcome Measures :
  1. Helicobacter pylori eradication rate [ Time Frame: Six weeks after completion of therapy ]
    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).


Secondary Outcome Measures :
  1. Rate of adverse effects [ Time Frame: Within 7 days after completion of therapy ]
    The subjects were asked to grade the severity of adverse events according to their influence on daily activities, experienced as "mild" (transient and well tolerated), "moderate" (causing discomfort and partially interfering with daily activities), or "severe" (causing considerable interference with daily activities)

  2. Compliance rate [ Time Frame: Within 7 days after completion of therapy ]
    Compliance was defined as poor when they had taken less than 80% of the total medication.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Administration of antibiotics, bismuth, antisecretory drugs in 8 weeks prior to inclusion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03708848


Contacts
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Contact: Laisheng Luo, M.D 86+18758279101 luolaishengzju@163.com

Locations
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China, Shanghai
Renji Hospital, School of Medicine, Shanghai Jiao Tong University Recruiting
Shanghai, Shanghai, China, 200127
Contact: Laisheng Luo, M.D.    86+18758279101    luolaishengzju@163.com   
Principal Investigator: Hong Lu, M.D.,Ph.D         
Sub-Investigator: Laisheng Luo, M.D.         
Sub-Investigator: Lou Yu, M.D         
Sub-Investigator: Xiaohua Long, M.D.         
Sub-Investigator: Xiao Liang, M.D.,Ph.D         
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
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Principal Investigator: Hong Lu, M.D.,Ph.D. Renji Hospital, School of Medicine, Shanghai Jiao Tong University

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Responsible Party: Hong Lu, MD, Medical Doctor of Division of Gastroenterology and Hepatology of Renji Hospital,Professor of Medicine, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT03708848     History of Changes
Other Study ID Numbers: rjkls2017197
First Posted: October 17, 2018    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Hong Lu, MD, Shanghai Jiao Tong University School of Medicine:
Helicobacter pylori
Tailored therapy
Penicillin allergy
Antimicrobial susceptibility testing

Additional relevant MeSH terms:
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Gram-Negative Bacterial Infections
Bacterial Infections
Hypersensitivity
Helicobacter Infections
Drug Hypersensitivity
Immune System Diseases
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Anti-Bacterial Agents
Metronidazole
Clarithromycin
Levofloxacin
Ofloxacin
Penicillins
Tetracycline
Antibiotics, Antitubercular
Citric Acid
Sodium Citrate
Esomeprazole
Bismuth
Potassium Citrate
Anti-Infective Agents
Antitubercular Agents
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Antiprotozoal Agents
Antiparasitic Agents