Effectiveness of Rifabutin for Treatment of Helicobacter Pylori

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2023-07-31

Brief Summary

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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

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Detailed Description

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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).

Conditions

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Helicobacter Infections Resistance Bacterial Gastritis H Pylori

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, open-label, non-blinded

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rifabutin full dose

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

Group Type ACTIVE_COMPARATOR

Rifabutin

Intervention Type DRUG

150 mg

Amoxicillin

Intervention Type DRUG

1000 mg

Esomeprazole

Intervention Type DRUG

40 mg

Rifabutin low dose

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

Group Type ACTIVE_COMPARATOR

Rifabutin

Intervention Type DRUG

150 mg

Amoxicillin

Intervention Type DRUG

1000 mg

Esomeprazole

Intervention Type DRUG

40 mg

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

Group Type ACTIVE_COMPARATOR

Amoxicillin

Intervention Type DRUG

1000 mg

Esomeprazole

Intervention Type DRUG

40 mg

Clarithromycin

Intervention Type DRUG

500 mg

Tinidazole

Intervention Type DRUG

500 mg

Interventions

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Rifabutin

150 mg

Intervention Type DRUG

Amoxicillin

1000 mg

Intervention Type DRUG

Esomeprazole

40 mg

Intervention Type DRUG

Clarithromycin

500 mg

Intervention Type DRUG

Tinidazole

500 mg

Intervention Type DRUG

Other Intervention Names

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mycobutin® Amoxil® "nexium" Biaxin® protocide®

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No