J-C Delchier1, S Bastuji-Garin2, J Raymond3, F Megraud4, A Amiot5, E Cambau6, C Burucoa7. 1. Inserm, centre d'investigation clinique 1430 et plateforme de ressources biologiques, département de gastroentérologie, université Paris Est Créteil (UPEC), hôpital Henri-Mondor, AP-HP, 94010 Créteil cedex, France. 2. Service santé publique et unité de recherche clinique (URC-Mondor), hôpital Henri-Mondor, AP-HP, 94010 Créteil, France; LIC EA4393 (laboratoire d'investigation clinique), université Paris Est (UPE), 94010 Créteil, France. 3. Laboratoire de bactériologie, université Paris VII, hôpital Cochin, AP-HP, 75014 Paris, France. 4. Laboratoire de bactériologie, Centre national de référence des campylobacter et helicobacter, université de Bordeaux, 33076 Bordeaux, France. 5. Inserm, centre d'investigation clinique 1430 et plateforme de ressources biologiques, département de gastroentérologie, université Paris Est Créteil (UPEC), hôpital Henri-Mondor, AP-HP, 94010 Créteil cedex, France. Electronic address: aurelien.amiot@aphp.fr. 6. UMR 1137 Inserm, service de bactériologie, université Paris Diderot, hôpitaux universitaires Lariboisière-Saint-Louis, AP-HP, 75010 Paris, France. 7. EA 4331 LITEC, service de bactériologie-hygiène, faculté de médecine et de pharmacie, université de Poitiers, CHU de Poitiers, Poitiers, France.
Abstract
INTRODUCTION: Resistance to clarithromycin and fluoroquinolones is increasing in many countries. We aimed to assess the efficacy of a tailored PCR-guided triple therapy versus an empirical triple therapy in the treatment of H. pylori infection. PATIENTS AND METHODS: French multicenter prospective open-label randomized study to assess H. pylori and resistance to clarithromycin and levofloxacin with GenoType HelicoDR® test. Patients of the control group were treated with empirical therapy of proton pump inhibitor (PPI), amoxicillin, and clarithromycin for 7 days. Patients of the experimental group with clarithromycin-susceptible strains, clarithromycin-resistant/levofloxacin-susceptible strains, and with clarithromycin-resistant/levofloxacin-resistant strains received tailored therapy of PPI, amoxicillin, and clarithromycin for 7 days, PPI, amoxicillin, and levofloxacin for 10 days, and PPI, amoxicillin, and metronidazole for 14 days, respectively. H. pylori eradication was assessed by 13C urea breath test at least 28 days after the end of treatment. RESULTS: We included 526 patients: 260 (49.4%) were randomly assigned to empirical triple therapy and 266 (50.6%) to tailored therapy. Clarithromycin and levofloxacin resistances were 23.3% and 12.8%, respectively. Follow-up urea breath test was available for 415 (78.9%) patients. Tailored therapy was superior to empirical therapy in terms of eradication (85.5% vs. 73.1%, RR=1.85, 95%CI [1.25-2.78], p=0.003). Findings were consistent in the susceptibility analysis using multiple imputation (RR=1.61, 95%CI [1.14-2.27], P=0.003) and per-protocol analysis (RR=1.89, 95%CI [0.25-2.78], p=0.003). CONCLUSION: In a country with a high level of clarithromycin resistance, tailored PCR-guided therapy was superior to empirical triple therapy for H. pylori eradication (https://www.ClinicalTrials.gov: NCT01168063).
RCT Entities:
INTRODUCTION: Resistance to clarithromycin and fluoroquinolones is increasing in many countries. We aimed to assess the efficacy of a tailored PCR-guided triple therapy versus an empirical triple therapy in the treatment of H. pylori infection. PATIENTS AND METHODS: French multicenter prospective open-label randomized study to assess H. pylori and resistance to clarithromycin and levofloxacin with GenoType HelicoDR® test. Patients of the control group were treated with empirical therapy of proton pump inhibitor (PPI), amoxicillin, and clarithromycin for 7 days. Patients of the experimental group with clarithromycin-susceptible strains, clarithromycin-resistant/levofloxacin-susceptible strains, and with clarithromycin-resistant/levofloxacin-resistant strains received tailored therapy of PPI, amoxicillin, and clarithromycin for 7 days, PPI, amoxicillin, and levofloxacin for 10 days, and PPI, amoxicillin, and metronidazole for 14 days, respectively. H. pylori eradication was assessed by 13C urea breath test at least 28 days after the end of treatment. RESULTS: We included 526 patients: 260 (49.4%) were randomly assigned to empirical triple therapy and 266 (50.6%) to tailored therapy. Clarithromycin and levofloxacin resistances were 23.3% and 12.8%, respectively. Follow-up urea breath test was available for 415 (78.9%) patients. Tailored therapy was superior to empirical therapy in terms of eradication (85.5% vs. 73.1%, RR=1.85, 95%CI [1.25-2.78], p=0.003). Findings were consistent in the susceptibility analysis using multiple imputation (RR=1.61, 95%CI [1.14-2.27], P=0.003) and per-protocol analysis (RR=1.89, 95%CI [0.25-2.78], p=0.003). CONCLUSION: In a country with a high level of clarithromycin resistance, tailored PCR-guided therapy was superior to empirical triple therapy for H. pylori eradication (https://www.ClinicalTrials.gov: NCT01168063).
Authors: Rebecca Marrero Rolon; Scott A Cunningham; Jayawant N Mandrekar; Erin T Polo; Robin Patel Journal: J Clin Microbiol Date: 2021-04-20 Impact factor: 5.948