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Trial record 84 of 215 for:    TETRACYCLINE

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

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ClinicalTrials.gov Identifier: NCT04107194
Recruitment Status : Not yet recruiting
First Posted : September 27, 2019
Last Update Posted : September 27, 2019
Sponsor:
Information provided by (Responsible Party):
Alfredo Di Leo, University of Bari

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Antibiotic Resistant Infection Antibiotic Resistant Strain Drug: Pantoprazole 40mg Drug: Amoxicillin 1000 MG Drug: Clarithromycin 500mg Drug: Metronidazole Drug: Tetracycline 125 MG Drug: Bismuth Subcitrate Drug: Rifabutin 150 MG Drug: Levofloxacin 500mg Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 362 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Open-label, multicenter, parallel-arm randomized controlled trial
Masking: Single (Outcomes Assessor)
Masking Description: Investigators performing urea breath test 30 days after the end of the treatment (assessment of the primary outcome: eradication rate) will not be aware of participants' allocation and received therapy. Moreover, two independent investigators will perform RT-PCR on stool samples and gastric biopsy specimens, blinded to the other test results.
Primary Purpose: Treatment
Official Title: 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.
Estimated Study Start Date : October 14, 2019
Estimated Primary Completion Date : February 14, 2021
Estimated Study Completion Date : April 14, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

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 Name: Pantorc

Drug: Amoxicillin 1000 MG
Antibiotic
Other Name: Zimox

Drug: Clarithromycin 500mg
Antibiotic
Other Name: Klacid

Drug: Metronidazole
Antibiotic
Other Name: Flagyl

Drug: Tetracycline 125 MG
Antibiotic
Other Name: Ambramicina

Drug: Bismuth Subcitrate
Antibiotic adjuvant
Other Name: Denol

Drug: Rifabutin 150 MG
Antibiotic
Other Name: Mycobutin

Drug: Levofloxacin 500mg
Antibiotic
Other Name: 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 Name: Pantorc

Drug: Amoxicillin 1000 MG
Antibiotic
Other Name: Zimox

Drug: Clarithromycin 500mg
Antibiotic
Other Name: Klacid

Drug: Metronidazole
Antibiotic
Other Name: Flagyl

Drug: Tetracycline 125 MG
Antibiotic
Other Name: Ambramicina

Drug: Bismuth Subcitrate
Antibiotic adjuvant
Other Name: Denol




Primary Outcome Measures :
  1. Eradication rate [ Time Frame: 30 days ]
    Number of participants achieving Helicobacter pylori eradication


Secondary Outcome Measures :
  1. Adverse events [ Time Frame: 10 days ]
    Any adverse event occurring during the 10-day treatment

  2. Participants' compliance [ Time Frame: 10 days ]
    Number of assumed tablets divided by the total number of prescribed tablets

  3. Treatment withdrawal [ Time Frame: 10 days ]
    Withdrawal of any drug included in the prescribed regimen


Other Outcome Measures:
  1. 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



Information from the National Library of Medicine

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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:

  • 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.

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): NCT04107194


Contacts
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Contact: Michele Barone, Prof. +39 3477157666 michele.barone@uniba.it

Locations
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Italy
Michele Barone
Bari, BA, Italy, 70124
Sponsors and Collaborators
University of Bari
Investigators
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Principal Investigator: Mariabeatrice Principi, Prof. University of Bari

Publications of Results:
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Responsible Party: Alfredo Di Leo, Professor of University of Bari, University of Bari
ClinicalTrials.gov Identifier: NCT04107194     History of Changes
Other Study ID Numbers: Policlinic Hospital 6, Bari
First Posted: September 27, 2019    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019
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
Additional relevant MeSH terms:
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Tetracycline
Infection
Communicable Diseases
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Anti-Bacterial Agents
Amoxicillin
Metronidazole
Clarithromycin
Levofloxacin
Ofloxacin
Rifabutin
Bismuth tripotassium dicitrate
Pantoprazole
Bismuth
Anti-Infective Agents
Antibiotics, Antitubercular
Antitubercular Agents
Antiprotozoal Agents
Antiparasitic Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Anti-Infective Agents, Urinary
Renal Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors