Effectiveness of Rifabutin for Treatment of Helicobacter Pylori

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT04652284

Recruitment Status : Not yet recruiting

First Posted : December 3, 2020

Last Update Posted : March 10, 2021

See Contacts and Locations

Sponsor:

Information provided by (Responsible Party):

Rabin Medical Center

Study Description

Brief Summary:

The aim of this study is to determine the effectiveness of rifabutin triple therapy for the treatment of H. pylori infection in the Israeli population. Patients with or without a prior history of H. pylori eradication failure will be randomized to receive one of three possible treatments:

Group 1-amoxicillin 1000mg bd and rifabutin 150 mg bd and esomeprazole 40 mg bd Group 2- amoxicillin 1000mg bd and rifabutin 150 mg d and esomeprazole 40 mg bd Group 3- standard of care

Condition or disease	Intervention/treatment	Phase
Helicobacter Infections Resistance Bacterial Gastritis H Pylori	Drug: Rifabutin Drug: Amoxicillin Drug: Esomeprazole Drug: Clarithromycin Drug: Tinidazole	Phase 3

Detailed Description:

Patients who present to the outpatient gastroenterology clinic at our institution with a positive diagnostic test for H pylori will be screened. Included patients will undergo randomisation into 3 groups. Randomization will be performed by a random sequence generator to create equal sized groups in boxes of 12.

Group 1-amoxicillin 1000mg bd and rifabutin 150 mg bd and esomeprazole 40 mg bd Group 2- amoxicillin 1000mg bd and rifabutin 150 mg d and esomeprazole 40 mg bd Group 3- standard of care Standard of care in previously untreated patients will consist of concomitant treatment (amoxicillin 1000mg, clarithromycin 500 mg, tinidazole 500 mg and esomeprazole all given twice daily for 14 days). In previously treated patients standard of care will consist of bismuth quadruple therapy, quinolone based therapy, or other susceptibility guided treatment where available.

Treatment duration will be 14 days in all groups. Patients who are randomised to Group 3 and fail treatment will be offered open label rescue treatment with amoxicillin 1000mg bd, rifabutin 150 mg bd and esomeprazole 40 mg bd (14 days).

Study Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	300 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Intervention Model Description:	Randomized, open-label, non-blinded
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Effectiveness of Rifabutin Triple Therapy for First-line and Rescue Treatment of Helicobacter Pylori Infection
Estimated Study Start Date :	May 1, 2021
Estimated Primary Completion Date :	May 31, 2023
Estimated Study Completion Date :	July 31, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Rifabutin

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Rifabutin full dose oral amoxicillin 1000mg bd and rifabutin 150 mg bd and esomeprazole 40 mg bd 14 days	Drug: Rifabutin 150 mg Other Name: mycobutin® Drug: Amoxicillin 1000 mg Other Name: Amoxil® Drug: Esomeprazole 40 mg Other Name: "nexium"
Active Comparator: Rifabutin low dose oral amoxicillin 1000mg bd and rifabutin 150 mg d and esomeprazole 40 mg bd 14 days	Drug: Rifabutin 150 mg Other Name: mycobutin® Drug: Amoxicillin 1000 mg Other Name: Amoxil® Drug: Esomeprazole 40 mg Other Name: "nexium"
Active Comparator: Standard of Care Standard of care in previously untreated patients will consist of concomitant treatment (oral amoxicillin 1000mg, clarithromycin 500 mg, tinidazole 500 mg and esomeprazole 40 mg all given twice daily for 14 days). In previously treated patients standard of care will consist of bismuth quadruple therapy, quinolone based therapy, or other susceptibility guided treatment where available	Drug: Amoxicillin 1000 mg Other Name: Amoxil® Drug: Esomeprazole 40 mg Other Name: "nexium" Drug: Clarithromycin 500 mg Other Name: Biaxin® Drug: Tinidazole 500 mg Other Name: protocide®

Outcome Measures

Primary Outcome Measures :

Success of H. pylori treatment [ Time Frame: 6 weeks following end of treatment ]
Negative 13C-urea breath test or Helicobacter pylori Stool Ag

Secondary Outcome Measures :

Incidence of treatment-emergent adverse events [ Time Frame: 14 days treatment ]
Daily entry of Likert scale (0-10) for the following parameters: diarrhea, nausea, abdominal pain, dyspepsia, reflux, loss of appetite, asthenia and others (free text). Adverse effects leading to treatment discontinuation. Serious adverse events leading to leading to patient's hospitalization, disability, or death, or to birth defects on pregnant patients
Compliance with H. pylori treatment [ Time Frame: 14 days treatment ]
Assessed by diary entry twice daily. If more than 80% of pills taken, patient considered to be treatment compliant.

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	18 Years to 99 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients presenting to outpatient clinic with evidence of H. pylori infection

Exclusion Criteria:

allergy to any of the study drugs
prior exposure to rifamycin drugs
inability to provide informed consent
pregnancy or lactation
liver disease
haematological disease
renal failure
active malignancy
immune suppression
patients not expected to benefit from Helicobacter pylori eradication

Contacts and Locations

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): NCT04652284

Contacts

Layout table for location contacts

Contact: Doron Boltin, MBBS	972504488881	dboltin@gmail.com

Sponsors and Collaborators

Rabin Medical Center

Investigators

Layout table for investigator information

Principal Investigator:	Doron Boltin, MBBS	Rabin Medical Center

More Information

Publications of Results:

Gingold-Belfer R, Niv Y, Levi Z, Boltin D. Rifabutin triple therapy for first-line and rescue treatment of Helicobacter pylori infection: A systematic review and meta-analysis. J Gastroenterol Hepatol. 2021 Jun;36(6):1392-1402. doi: 10.1111/jgh.15294. Epub 2020 Oct 29.

Graham DY, Canaan Y, Maher J, Wiener G, Hulten KG, Kalfus IN. Rifabutin-Based Triple Therapy (RHB-105) for Helicobacter pylori Eradication: A Double-Blind, Randomized, Controlled Trial. Ann Intern Med. 2020 Jun 16;172(12):795-802. doi: 10.7326/M19-3734. Epub 2020 May 5.

Borody TJ, Pang G, Wettstein AR, Clancy R, Herdman K, Surace R, Llorente R, Ng C. Efficacy and safety of rifabutin-containing 'rescue therapy' for resistant Helicobacter pylori infection. Aliment Pharmacol Ther. 2006 Feb 15;23(4):481-8. Erratum in: Aliment Pharmacol Ther. 2006 Jul 15;24(2):439.

Perri F, Festa V, Clemente R, Villani MR, Quitadamo M, Caruso N, Bergoli ML, Andriulli A. Randomized study of two "rescue" therapies for Helicobacter pylori-infected patients after failure of standard triple therapies. Am J Gastroenterol. 2001 Jan;96(1):58-62.

Layout table for additonal information

Responsible Party:	Rabin Medical Center
ClinicalTrials.gov Identifier:	NCT04652284
Other Study ID Numbers:	900-20-RMC
First Posted:	December 3, 2020 Key Record Dates
Last Update Posted:	March 10, 2021
Last Verified:	October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	anonymized IPD will be available upon request
Supporting Materials:	Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF)
Time Frame:	will be available following publication of results for a period of 7 years

Layout table for additional information

Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No
Product Manufactured in and Exported from the U.S.:	No

Additional relevant MeSH terms:

Layout table for MeSH terms

Infections Helicobacter Infections Gastritis Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Stomach Diseases Gram-Negative Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses Amoxicillin Clarithromycin Rifabutin Tinidazole Esomeprazole	Anti-Bacterial Agents Anti-Infective Agents Anti-Ulcer Agents Gastrointestinal Agents Proton Pump Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Protein Synthesis Inhibitors Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Antibiotics, Antitubercular Antitubercular Agents Alkylating Agents Antitrichomonal Agents Antiprotozoal Agents

To Top