Helicobacter Infections Clinical Trial
Official title:
Effectiveness of Rifabutin Triple Therapy for First-line and Rescue Treatment of Helicobacter Pylori Infection
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
Status | Not yet recruiting |
Enrollment | 300 |
Est. completion date | July 31, 2023 |
Est. primary completion date | May 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Rabin Medical Center |
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: Alimen — View Citation
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. 2020 Oct 10. doi: 10.1111/jgh.15294. [Epub ahead of p — View Citation
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. E — View Citation
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):5 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Success of H. pylori treatment | Negative 13C-urea breath test or Helicobacter pylori Stool Ag | 6 weeks following end of treatment | |
Secondary | 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 | 14 days treatment | |
Secondary | Compliance with H. pylori treatment | Assessed by diary entry twice daily. If more than 80% of pills taken, patient considered to be treatment compliant. | 14 days treatment |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00723502 -
Efficacy and Safety Study of Finafloxacin Used in Helicobacter Pylori Infected Patients
|
Phase 2 | |
Recruiting |
NCT03365609 -
A Comparison of Four Different Treatment Regimens of Helicobacter Pylori in Chinese Children
|
N/A | |
Completed |
NCT00005496 -
Inflammation, Infection, and Future Cardiovascular Risk
|
N/A | |
Completed |
NCT01219764 -
A Trial of Standard vs Half Dose Rabeprazole, Clarithromycin, Metronidazole and Amoxicillin in the Treatment of Helicobacter Pylori Infection
|
Phase 4 | |
Completed |
NCT00216450 -
Study of the Safety and Effectiveness of Rabeprazole in Treatment of Helicobacter Pylori Infection in Adults.
|
Phase 4 | |
Completed |
NCT00212225 -
Risk Factors for Gastric Disease in Pediatric Helicobacter Pylori (H. Pylori)
|
N/A | |
Completed |
NCT00083291 -
Helicobacter Pylori and Dry Eye
|
N/A | |
Completed |
NCT02449941 -
Helicobacter Pylori and Proton Pump Inhibitor
|
N/A | |
Completed |
NCT02395458 -
Efficacy on Helicobacter Pylori Eradication With Two Antibiotic Regimens
|
Phase 4 | |
Completed |
NCT00194688 -
Breath Ammonia Method for H. Pylori Detection: Phase II
|
Phase 2 | |
Not yet recruiting |
NCT02126722 -
Endofaster Test for Helicobacter Pylori Detection in Patients on Proton Pump Inhibitor Therapy
|
N/A | |
Active, not recruiting |
NCT01133951 -
Helicobacter Pylori Eradication to Prevent Gastric Cancer
|
N/A | |
Completed |
NCT00669955 -
Efficacy and Safety of Quadruple Therapy in Eradication of H. Pylori: A Comparison to Triple Therapy
|
Phase 3 | |
Completed |
NCT00816140 -
Levofloxacin Versus Clarithromycin Triple Therapy in First-Line Treatment for Helicobacter Pylori Eradication
|
Phase 4 | |
Completed |
NCT00490386 -
Helicobacter Pylori and Acute Alcohol Induced Pancreatitis
|
N/A | |
Withdrawn |
NCT02645201 -
The Effect of Probiotic Combination on Helicobacter Pylori Infection in Children
|
N/A | |
Terminated |
NCT00664209 -
Treating H. Pylori in Parkinson's Patients With Motor Fluctuations
|
Phase 3 | |
Completed |
NCT01922505 -
Eradication Rates of Helicobacter Pylori and Its Affecting Factors
|
Phase 4 | |
Completed |
NCT01792700 -
Long-term Follow up Helicobacter Pylori Reinfection Rate After Second-Line Treatment: Bismuth-Containing Quadruple Therapy Versus Moxifloxacin-Based Triple Therapy
|
Phase 4 | |
Completed |
NCT02970110 -
Specimen Collection Study for H. Pylori Testing
|