Effectiveness of Rifabutin for Treatment of Helicobacter Pylori

NCT04652284 | Unknown Phase 3 DMC FDA Drug

• 1 other identifier: 900-20-RMC
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

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

Conditions

Helicobacter Infections; Resistance Bacterial; Gastritis H Pylori

Outcome Measures

Primary Outcomes (1)

• Success of H. pylori treatment

  Negative 13C-urea breath test or Helicobacter pylori Stool Ag

  6 weeks following end of treatment

Secondary Outcomes (2)

• Incidence of treatment-emergent adverse events

  14 days treatment

• Compliance with H. pylori treatment

  14 days treatment

Study Arms (3)

Rifabutin full dose

ACTIVE COMPARATOR

oral amoxicillin 1000mg bd and rifabutin 150 mg bd and esomeprazole 40 mg bd 14 days

Drug: Rifabutin; Drug: Amoxicillin; Drug: Esomeprazole

Rifabutin low dose

ACTIVE COMPARATOR

oral amoxicillin 1000mg bd and rifabutin 150 mg d and esomeprazole 40 mg bd 14 days

Drug: Rifabutin; Drug: Amoxicillin; Drug: Esomeprazole

Standard of Care

ACTIVE COMPARATOR

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; Drug: Esomeprazole; Drug: Clarithromycin; Drug: Tinidazole

Interventions

Rifabutin DRUG

150 mg

Also known as: mycobutin®

Rifabutin full dose; Rifabutin low dose

Amoxicillin DRUG

1000 mg

Also known as: Amoxil®

Rifabutin full dose; Rifabutin low dose; Standard of Care

Esomeprazole DRUG

40 mg

Also known as: "nexium"

Rifabutin full dose; Rifabutin low dose; Standard of Care

Clarithromycin DRUG

500 mg

Also known as: Biaxin®

Standard of Care

Tinidazole DRUG

500 mg

Also known as: protocide®

Standard of Care

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rabin Medical Center: lead

Related Publications (4)

• 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.

  PMID: 33037845 RESULT

• 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.

  PMID: 32365359 RESULT

• 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. doi: 10.1111/j.1365-2036.2006.02793.x.

  PMID: 16441468 RESULT

• 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. doi: 10.1111/j.1572-0241.2001.03452.x.

  PMID: 11197288 RESULT

MeSH Terms

Conditions

Helicobacter Infections

Interventions

Rifabutin; Amoxicillin; Esomeprazole; Clarithromycin; Tinidazole

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Pyridines; Heterocyclic Compounds, 1-Ring; Benzimidazoles; Erythromycin; Macrolides; Polyketides; Lactones; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles

Study Officials

• Doron Boltin, MBBS

  Rabin Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Doron Boltin, MBBS

CONTACT

972504488881; dboltin@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, open-label, non-blinded

Study Record Dates

• First Submitted: November 1, 2020
• First Posted: December 3, 2020
• Study Start: May 1, 2021
• Primary Completion: May 31, 2023
• Study Completion: July 31, 2023
• Last Updated: March 10, 2021

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: will be available following publication of results for a period of 7 years