Effectiveness of Rifabutin for Treatment of Helicobacter Pylori

Clalit Health Services

Status and phase: Unknown; Phase 3

Conditions: Helicobacter Infections; Gastritis H Pylori; Resistance Bacterial

Treatments: Drug: Amoxicillin; Drug: Rifabutin; Drug: Tinidazole; Drug: Clarithromycin; Drug: Esomeprazole

Study type: Interventional

Funder types: Other

Identifiers

NCT04652284

900-20-RMC

Details and patient eligibility

About

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

Full 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).

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 3 patient groups

Rifabutin full dose

Active Comparator group

Description:

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

Treatment:

Drug: Esomeprazole

Drug: Rifabutin

Drug: Amoxicillin

Rifabutin low dose

Active Comparator group

Description:

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

Treatment:

Drug: Esomeprazole

Drug: Rifabutin

Drug: Amoxicillin

Standard of Care

Active Comparator group

Description:

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

Treatment:

Drug: Clarithromycin

Drug: Esomeprazole

Drug: Tinidazole

Drug: Amoxicillin