drugset / Trial / NCT02726269
Triple Therapy Versus Levofloxacin-based Therapy for Helicobacter Pylori Eradication in Mexico.
Phase 3
Completed
230 enrolled
Asofarma de México S.A de C.V.
Centro InmunoQ, Mexico City · collabCentro Médico ABC Observatorio, Mexico City · collabHospital Ángeles Metropolitano, Mexico City · collabHospital Ángeles, Clínica Londres, Mexico City · collabTorre Mayo, Metepec, State of Mexico · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The goal of this trial is to compare the non-inferiority efficacy and safety of two different treatment schemes: pantoprazole 80 mg + levofloxacin 500 mg + azithromycin 500 mg once daily (PLA, test) vs. clarithromycin 500 mg + lansoprazole 30 mg + amoxicillin 1 g twice daily (CLA, reference), each during 10 days, over Helicobacter Pylori (HP) eradication. Both schemes will be tested in treatment-naive patients, with biopsy-based diagnosis for HP infection. One month after finishing each treatment, C13-urea breath testing will be required to verify HP eradication. Biopsies will also be taken to identify Clarithromycin-resistance mutations in HP strains by fluorescence in situ hybridization (FISH).
Timeline
- Start
- 2012-06
- Primary completion
- 2014-03
- Completion
- 2014-05
Publications
- Background Cuadrado-Lavin A, Salcines-Caviedes JR, Carrascosa MF, Dierssen-Sotos T, Cobo M, Campos MR, Ayestaran B, Fernandez-Pousa A, Gonzalez-Colominas E, Aresti-Zarate S, Hernandez M, Pascual EL. Levofloxacin versus clarithromycin in a 10 day triple therapy regimen for first-line Helicobacter pylori eradication: a single-blind randomized clinical trial. J Antimicrob Chemother. 2012 Sep;67(9):2254-9. doi: 10.1093/jac/dks209. Epub 2012 Jun 11.
- Background Chihu L, Ayala G, Mohar A, Hernandez A, Herrera-Goepfert R, Fierros G, Gonzalez-Marquez H, Silva J. Antimicrobial resistance and characterization of Helicobacter pylori strains isolated from Mexican adults with clinical outcome. J Chemother. 2005 Jun;17(3):270-6. doi: 10.1179/joc.2005.17.3.270.
- Background Piaggio G, Elbourne DR, Pocock SJ, Evans SJ, Altman DG; CONSORT Group. Reporting of noninferiority and equivalence randomized trials: extension of the CONSORT 2010 statement. JAMA. 2012 Dec 26;308(24):2594-604. doi: 10.1001/jama.2012.87802.
- Ladron-de-Guevara L, Bornstein-Quevedo L, Gonzalez-Huezo S, Castaneda-Romero B, Costa FG, di Silvio-Lopez M. Helicobacter pylori eradication in Mexico with a levofloxacin-based scheme versus standard triple therapy: Results from an open-label, randomized, noninferiority phase iiib trial. Rev Gastroenterol Mex (Engl Ed). 2019 Jul-Sep;84(3):274-283. doi: 10.1016/j.rgmx.2018.04.005. Epub 2018 Jul 27. English, Spanish.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Amoxicillin | Other / unclassified | 1 g | Oral |
| Subject | Azithromycin | Small molecule | 500 mg | Oral |
| Comparator | Clarithromycin | Small molecule | 500 mg | Oral |
| Comparator | Lansoprazole | Other / unclassified | 30 mg | Oral |
| Subject | Levofloxacin | Small molecule | 500 mg | Oral |
| Subject | Pantoprazole | Other / unclassified | 80 mg | Oral |