Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04652284
Other study ID # 900-20-RMC
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date May 1, 2021
Est. completion date July 31, 2023

Study information

Verified date October 2020
Source Rabin Medical Center
Contact Doron Boltin, MBBS
Phone 972504488881
Email dboltin@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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).


Recruitment information / eligibility

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

Study Design


Intervention

Drug:
Rifabutin
150 mg
Amoxicillin
1000 mg
Esomeprazole
40 mg
Clarithromycin
500 mg
Tinidazole
500 mg

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Rabin Medical Center

References & Publications (4)

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

Outcome

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
See also
  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 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 NCT01922505 - Eradication Rates of Helicobacter Pylori and Its Affecting Factors Phase 4
Completed NCT02970110 - Specimen Collection Study for H. Pylori Testing