Non-invasive Test-guided Tailored Therapy Versus Empiric Treatment for Helicobacter Pylori Infection. (THD-HP)

January 11, 2021 updated by: Alfredo Di Leo, University of Bari

Comparison Between Tailored Therapy Guided by a Non-invasive Antibiotic Susceptibility Test and Empiric Treatment for First-line Helicobacter Pylori Eradication in Patients With Dyspepsia: a Randomized Controlled Trial.

The aim of our study will be to assess in an open-label, multicenter, randomized controlled trial whether a tailored therapy guided by a non-invasive antibiotic susceptibility test on stool samples achieves higher Helicobacter eradication rates than an empiric antibiotic regimen. For this purpose, consecutive patients with dyspeptic symptoms, diagnosis of Helicobacter pylori infection and naïve to eradicating treatments will be allocated to either of the two intervention arms.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Study design:

Eligible subjects will be defined by the positivity to at least 2 out of 4 tests for Helicobacter pylori infection diagnosis (i.e. histology, rapid urease test, urea breath test and serology). Stool samples and gastric biopsy specimens of eligible patients will be analyzed at enrollment, using real time-polymerase chain reaction (RT-PCR) to detect bacterial DNA mutations conferring resistance to amoxicillin, clarithromycin, tetracycline, metronidazole, and levofloxacin. Participants allocated to the tailored intervention arm will receive an antibiotic combination therapy according to the result of stool sample molecular analysis. Participants allocated to the empiric intervention arm will be treated by either a quadruple concomitant or bismuth-containing regimen, according to the 2017 European Helicobacter pylori management guidelines. In all participants, infection eradication will be evaluated 30 days after treatment end, using urea breath test. We will also assess the diagnostic accuracy of the RT-PCR on fecal samples in detecting bacterial antibiotic resistances, using the RT-PCR on gastric biopsy specimens as the reference standard.

Study Type

Interventional

Enrollment (Anticipated)

362

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • presence of dyspeptic symptoms, according to Rome IV criteria;
  • Helicobacter pylori infection diagnosis by the positivity of at least 2 out of 4 diagnostic tests (i.e. histology, rapid urease test, urea breath test, and serology);
  • naive to Helicobacter pylori treatment;
  • written informed consent.

Exclusion Criteria:

  • previous Helicobacter pylori treatment;
  • diagnosis of gastric cancer or other diseases requiring surgery;
  • contraindications to upper endoscopy;
  • chronic diarrhea;
  • known allergy to any drugs used in the intervention and control arm.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tailored therapy

  1. Clarithromycin-sensitive strain (10 day-therapy):

    Pantoprazole 40 mg bid (tablet) Amoxicillin 1000 mg bid (tablet) Clarithromycin 500 mg bid (tablet) Metronidazole 500 mg bid (tablet)

  2. Clarithromycin-resistant and tetracycline-sensitive strain (10 day-therapy):

    Pantoprazole 40 mg bid (tablet) Tetracycline 125 mg + metronidazole 125 mg + bismuth 140 mg in a single tablet (3 tablets qid)

  3. Clarithromycin- and tetracycline-resistant and levofloxacin-sensitive strain (10 day- therapy):

    Pantoprazole 40 mg bid (tablet) Amoxicillin 1000 mg bid (tablet) Levofloxacin 500 mg bid (tablet)

  4. Clarithromycin-, tetracycline- and levofloxacin-resistant strain (10 day-therapy):

Pantoprazole 40 mg bid (tablet) Amoxicillin 1000 mg bid (tablet) Rifabutin 150 mg bid (tablet)
Drug: Pantoprazole 40mg
Proton pump inhibitor
Other Names:
  • Pantorc
Drug: Amoxicillin 1000 MG
Antibiotic
Other Names:
  • Zimox
Drug: Clarithromycin 500mg
Antibiotic
Other Names:
  • Klacid
Drug: Metronidazole
Antibiotic
Other Names:
  • Flagyl
Drug: Tetracycline 125 MG
Antibiotic
Other Names:
  • Ambramicina
Drug: Bismuth Subcitrate
Antibiotic adjuvant
Other Names:
  • Denol
Drug: Rifabutin 150 MG
Antibiotic
Other Names:
  • Mycobutin
Drug: Levofloxacin 500mg
Antibiotic
Other Names:
  • Levoxacin
Active Comparator: Empiric therapy

Either one of the two following 10-day regimens (according to physician's decision):

  1. Pantoprazole 40 mg bid (tablet) Amoxicillin 1000 mg bid (tablet) Clarithromycin 500 mg bid (tablet) Metronidazole 500 mg bid (tablet)
  2. Pantoprazole 40 mg bid (tablet) Tetracycline 125 mg + metronidazole 125 mg + bismuth 140 mg in a single tablet (3 tablets qid)
Drug: Pantoprazole 40mg
Proton pump inhibitor
Other Names:
  • Pantorc
Drug: Amoxicillin 1000 MG
Antibiotic
Other Names:
  • Zimox
Drug: Clarithromycin 500mg
Antibiotic
Other Names:
  • Klacid
Drug: Metronidazole
Antibiotic
Other Names:
  • Flagyl
Drug: Tetracycline 125 MG
Antibiotic
Other Names:
  • Ambramicina
Drug: Bismuth Subcitrate
Antibiotic adjuvant
Other Names:
  • Denol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eradication rate
Time Frame: 30 days
Number of participants achieving Helicobacter pylori eradication
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: 10 days
Any adverse event occurring during the 10-day treatment
10 days
Participants' compliance
Time Frame: 10 days
Number of assumed tablets divided by the total number of prescribed tablets
10 days
Treatment withdrawal
Time Frame: 10 days
Withdrawal of any drug included in the prescribed regimen
10 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy parameters
Time Frame: 30 days
Sensitivity, specificity, positive predictive value, negative predictive value, positive and negative likelihood ratio, and accuracy of the RT-PCR on fecal samples for the detection of antibiotic resistances
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bari

Investigators

  • Principal Investigator: Mariabeatrice Principi, Prof., University of Bari

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2020

Primary Completion (Anticipated)

February 14, 2021

Study Completion (Anticipated)

April 14, 2022

Study Registration Dates

First Submitted

September 25, 2019

First Submitted That Met QC Criteria

September 25, 2019

First Posted (Actual)

September 27, 2019

Study Record Updates

Last Update Posted (Actual)

January 12, 2021

Last Update Submitted That Met QC Criteria

January 11, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Policlinic Hospital 6, Bari

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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