Efficacy of a tailored PCR-guided triple therapy in the treatment of Helicobacter pylori infection.

Autor: Delchier JC; 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., Bastuji-Garin S; 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., Raymond J; Laboratoire de bactériologie, université Paris VII, hôpital Cochin, AP-HP, 75014 Paris, France., Megraud F; Laboratoire de bactériologie, Centre national de référence des campylobacter et helicobacter, université de Bordeaux, 33076 Bordeaux, France., Amiot A; 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., Cambau E; UMR 1137 Inserm, service de bactériologie, université Paris Diderot, hôpitaux universitaires Lariboisière-Saint-Louis, AP-HP, 75010 Paris, France., Burucoa C; EA 4331 LITEC, service de bactériologie-hygiène, faculté de médecine et de pharmacie, université de Poitiers, CHU de Poitiers, Poitiers, France.
Jazyk: angličtina
Zdroj: Medecine et maladies infectieuses [Med Mal Infect] 2020 Sep; Vol. 50 (6), pp. 492-499. Date of Electronic Publication: 2019 Jun 27.
DOI: 10.1016/j.medmal.2019.06.001
Abstrakt: 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 13 C 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).
(Copyright © 2019 Elsevier Masson SAS. All rights reserved.)
Databáze: MEDLINE
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