Non-invasive Test-guided Tailored Therapy Versus Empiric Treatment for Helicobacter Pylori Infection.

NCT04107194 | Unknown Phase 3

• 1 other identifier: Policlinic Hospital 6, Bari
• Study Type: interventional
• Target: 362
• Locations: 1 country
• Sites: 1

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.

Conditions

Helicobacter Pylori Infection; Antibiotic Resistant Infection; Antibiotic Resistant Strain

Outcome Measures

Primary Outcomes (1)

• Eradication rate

  Number of participants achieving Helicobacter pylori eradication

  30 days

Secondary Outcomes (3)

• Adverse events

  10 days

• Participants' compliance

  10 days

• Treatment withdrawal

  10 days

Other Outcomes (1)

• Diagnostic accuracy parameters

  30 days

Study Arms (2)

Tailored therapy

EXPERIMENTAL

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; Drug: Amoxicillin 1000 MG; Drug: Clarithromycin 500mg; Drug: Metronidazole; Drug: Tetracycline 125 MG; Drug: Bismuth Subcitrate; Drug: Rifabutin 150 MG; Drug: Levofloxacin 500mg

Empiric therapy

ACTIVE COMPARATOR

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; Drug: Amoxicillin 1000 MG; Drug: Clarithromycin 500mg; Drug: Metronidazole; Drug: Tetracycline 125 MG; Drug: Bismuth Subcitrate

Interventions

Pantoprazole 40mg DRUG

Proton pump inhibitor

Also known as: Pantorc

Empiric therapy; Tailored therapy

Amoxicillin 1000 MG DRUG

Antibiotic

Also known as: Zimox

Empiric therapy; Tailored therapy

Clarithromycin 500mg DRUG

Antibiotic

Also known as: Klacid

Empiric therapy; Tailored therapy

Metronidazole DRUG

Antibiotic

Also known as: Flagyl

Empiric therapy; Tailored therapy

Tetracycline 125 MG DRUG

Antibiotic

Also known as: Ambramicina

Empiric therapy; Tailored therapy

Bismuth Subcitrate DRUG

Antibiotic adjuvant

Also known as: Denol

Empiric therapy; Tailored therapy

Rifabutin 150 MG DRUG

Antibiotic

Also known as: Mycobutin

Tailored therapy

Levofloxacin 500mg DRUG

Antibiotic

Also known as: Levoxacin

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:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Bari: lead

Study Sites (1)

Michele Barone

Bari, BA, 70124, Italy

RECRUITING

Related Publications (5)

• Malfertheiner P, Megraud F, O'Morain CA, Gisbert JP, Kuipers EJ, Axon AT, Bazzoli F, Gasbarrini A, Atherton J, Graham DY, Hunt R, Moayyedi P, Rokkas T, Rugge M, Selgrad M, Suerbaum S, Sugano K, El-Omar EM; European Helicobacter and Microbiota Study Group and Consensus panel. Management of Helicobacter pylori infection-the Maastricht V/Florence Consensus Report. Gut. 2017 Jan;66(1):6-30. doi: 10.1136/gutjnl-2016-312288. Epub 2016 Oct 5.

  PMID: 27707777 RESULT

• Iannone A, Giorgio F, Russo F, Riezzo G, Girardi B, Pricci M, Palmer SC, Barone M, Principi M, Strippoli GF, Di Leo A, Ierardi E. New fecal test for non-invasive Helicobacter pylori detection: A diagnostic accuracy study. World J Gastroenterol. 2018 Jul 21;24(27):3021-3029. doi: 10.3748/wjg.v24.i27.3021.

  PMID: 30038469 RESULT

• Giorgio F, Ierardi E, Sorrentino C, Principi M, Barone M, Losurdo G, Iannone A, Giangaspero A, Monno R, Di Leo A. Helicobacter pylori DNA isolation in the stool: an essential pre-requisite for bacterial noninvasive molecular analysis. Scand J Gastroenterol. 2016 Dec;51(12):1429-1432. doi: 10.1080/00365521.2016.1216592. Epub 2016 Aug 9.

  PMID: 27687850 RESULT

• Drossman DA. Functional Gastrointestinal Disorders: History, Pathophysiology, Clinical Features and Rome IV. Gastroenterology. 2016 Feb 19:S0016-5085(16)00223-7. doi: 10.1053/j.gastro.2016.02.032. Online ahead of print.

  PMID: 27144617 RESULT

• De Francesco V, Giorgio F, Hassan C, Manes G, Vannella L, Panella C, Ierardi E, Zullo A. Worldwide H. pylori antibiotic resistance: a systematic review. J Gastrointestin Liver Dis. 2010 Dec;19(4):409-14.

  PMID: 21188333 RESULT

MeSH Terms

Interventions

Pantoprazole; Amoxicillin; Clarithromycin; Metronidazole; Tetracycline; bismuth tripotassium dicitrate; Rifabutin; Levofloxacin

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Erythromycin; Macrolides; Polyketides; Lactones; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Lactams, Macrocyclic; Macrocyclic Compounds; Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines

Study Officials

• Mariabeatrice Principi, Prof.

  University of Bari

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michele Barone, Prof.

CONTACT

+39 3477157666; michele.barone@uniba.it

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of University of Bari

Model Details: Open-label, multicenter, parallel-arm randomized controlled trial

Study Record Dates

• First Submitted: September 25, 2019
• First Posted: September 27, 2019
• Study Start: January 14, 2020
• Primary Completion: February 14, 2021
• Study Completion: April 14, 2022
• Last Updated: January 12, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)