14‐day tailored PCR‐guided triple therapy versus 14‐day non‐Bismuth concomitant quadruple therapy for Helicobacter pylori eradication: A multicenter, open‐label randomized noninferiority controlled trial

• Published in: Helicobacter (Cambridge, Mass.) Vol. 29; no. 2; pp. e13076 - n/a
• Main Authors: Amiot, Aurelien, Hacoon, Jérémy, Heluwaert, Frederic, Mion, François, Lamarque, Dominique, Moussata, Driffa, Mimouni, Maroua, Delchier, Jean‐Charles, Durand‐Zaleski, Isabelle, Audureau, Etienne, Bastuji‐Garin, Sylvie, Kedzia, Cecile, Samia, Baloul, Dalila, Selmane, Amel, Gouja, Petitdidier, Nicolas, Gagniere, Charlotte, Martin, Antoine, Levy, Michael, Nebbad, Biba, Sarlord, Helene, Dauwalder, Olivier, Roure‐Sobas, Chantal, Combes, Isabelle, Bland, Stephane, Bazin, Thomas, Lartigue, Marie‐Frederique
• Format: Journal Article
• Language: English
• Published: England Wiley Subscription Services, Inc 01.03.2024
• Subjects: Adult; Aged; Amoxicillin; Amoxicillin - administration & dosage; Amoxicillin - therapeutic use; Anti-Bacterial Agents - administration & dosage; Anti-Bacterial Agents - therapeutic use; Antibiotics; Bismuth; Clarithromycin; Clarithromycin - administration & dosage; Clarithromycin - therapeutic use; Cost analysis; Drug Therapy, Combination; Eradication; Female; Helicobacter Infections - drug therapy; Helicobacter Infections - microbiology; Helicobacter pylori; Helicobacter pylori - drug effects; Humans; Levofloxacin; Levofloxacin - administration & dosage; Levofloxacin - therapeutic use; Lower bounds; Male; Metronidazole; Metronidazole - administration & dosage; Metronidazole - therapeutic use; Middle Aged; Omeprazole; PCR; Polymerase Chain Reaction - methods; resistance; tailored therapy; Therapy; Treatment Outcome; Young Adult; tailored therapy; Helicobacter pylori; eradication; PCR; resistance
• ISSN: 1083-4389; 1523-5378
• DOI: 10.1111/hel.13076

Background The systematic use of susceptibility testing and tailored first‐line treatment for Helicobacter pylori eradication has yet to be established. Aim To compare 14‐day tailored PCR‐guided triple therapy to 14‐day non‐Bismuth concomitant quadruple therapy for first‐line Helicobacter pylori eradication. Patients and Methods We performed a multicenter, parallel‐group, randomized noninferiority controlled trial. Naive adult patients with Helicobacter pylori infection were treated with 14‐day tailored PCR‐guided triple therapy (esomeprazole 40 mg and amoxicillin 1000 mg b.d. plus clarithromycin 500 mg or levofloxacin 500 mg b.d. according to clarithromycin susceptibility) or 14‐day non‐Bismuth concomitant quadruple therapy (esomeprazole 40 mg, amoxicillin 1000 mg, clarithromycin 500 mg, and metronidazole 500 mg b.d.). The primary endpoint was H. pylori eradication. Results We screened 991 patients for eligibility and randomized 241 patients. The first‐line eradication rate was 99.2% in the tailored PCR‐guided group and 95.9% in the control group (ITT population; absolute difference of +3.30%, with a lower bound of CI at −0.68%). Both first‐line therapies were well tolerated, with a formally significant difference in favor of the tailored PCR‐guided group (61.4% vs. 41.2%, p = 0.003). Economic analyses revealed a lower cost of the tailored PCR‐guided arm, with a 92% chance of being jointly more effective and less expensive than the control arm in the ITT population. Conclusion In a country with a high level of clarithromycin resistance, the results of our study demonstrated the noninferiority of 14‐day tailored PCR‐guided triple therapy as a first‐line H. pylori eradication therapy compared to 14‐day non‐Bismuth quadruple therapy (ClinicalTrials.gov NCT02576236).