A Phase 3 interventional study of Rifabutin and Amoxicillin in Helicobacter Infections, Resistance Bacterial and Gastritis H Pylori, sponsored by Rabin Medical Center. Status unknown. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2021-03-10.
Sponsored by Rabin Medical Center · Phase 3, Interventional, and Treatment
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
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).
6,688 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 300 is above the median of 120 across 4,201 interventional studies indexed under Infections.
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Exclusion Criteria:
oral amoxicillin 1000mg bd and rifabutin 150 mg bd and esomeprazole 40 mg bd 14 days
Drug: Rifabutin · Drug: Amoxicillin · Drug: Esomeprazole
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 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
150 mg
Also known as: mycobutin®
1000 mg
Also known as: Amoxil®
40 mg
Also known as: "nexium"
500 mg
Also known as: Biaxin®
500 mg
Also known as: protocide®
Success of H. pylori treatment
Negative 13C-urea breath test or Helicobacter pylori Stool Ag
Time frame: 6 weeks following end of treatment
Incidence of treatment-emergent adverse events
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
Time frame: 14 days treatment
Compliance with H. pylori treatment
Assessed by diary entry twice daily. If more than 80% of pills taken, patient considered to be treatment compliant.
Time frame: 14 days treatment
No study locations are listed for this record.
Plan to share: Yes — anonymized IPD will be available upon request
Supporting information: Study protocol, Sap, Icf
This study is status unknown, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Rabin Medical Center